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Depressed patients who have become victim of violence are prone to revictimization. However, no evidence-based interventions aimed at reducing revictimization in this group exist. This multicenter randomized controlled trial evaluated the effectiveness of an internet-based emotion regulation training (iERT) added to TAU in reducing revictimization, emotion dysregulation, and depressive symptoms in recently victimized, depressed patients compared to TAU alone. Adult outpatients (N = 153) with a depressive disorder who had experienced threat, physical assault, or sexual assault within the previous three years were randomly allocated to TAU+iERT (n = 74) or TAU (n = 79). TAU involved psychotherapy (mainly cognitive behavioral therapy [77.8 %]). iERT comprised six guided online sessions focused on the acquisition of adaptive emotion regulation skills. The primary outcome measure was the number of revictimization incidents at 12 months after baseline, measured with the Safety Monitor. Analyses were performed according to the intention-to-treat principle. Both groups showed a large decrease in victimization incidents. Mixed-model negative binomial regression analyses showed that TAU+iERT was not effective in reducing revictimization compared to TAU (IRR = 0.97; 95%CI = 0.64,1.46; p =.886). Linear mixed-model analyses demonstrated that TAU+iERT yielded a larger reduction of emotion dysregulation (B = −7.217; p =.046; Cohens d = 0.33), but not depressive symptoms (B = −1.041; p =.607) than TAU. The study was underpowered to detect small treatment effects. Additionally, uptake of iERT was quite low. Although TAU+iERT resulted in a larger decrease of emotion dysregulation than TAU alone, it was not effective in reducing revictimization and depressive symptoms. Patients' revictimization risk substantially decreased during psychotherapy. • Online emotion regulation training improved emotion regulation in depressed patients. • iERT did not reduce revictimization rates or depressive symptoms compared to TAU. • Violent victimization rates decreased substantially during psychotherapy. [ABSTRACT FROM AUTHOR]

Subjective support could ameliorate the adverse effect of (pre)frailty on depressive symptoms. However, there is scarce evidence regarding subjective support-focused intervention in preventing depression among (pre)frail community-dwelling older adults. This study aims to explore the effectiveness of subjective support-focused cognitive behavioral therapy (SS-CBT) in preventing depression among this group of population. A total of 100 community-dwelling (pre)frail older adults were recruited from six communities in a Chinese city and were randomized to an 8-week SS-CBT group or a wait-list control group. Depressive symptoms and subjective support were assessed at baseline (T0), and at 8 week (T1), 12 week (T2), 16 week (T3) after randomization. Generalized estimating equation was used to examine the effectiveness of SS-CBT on depressive symptoms and subjective support. Hierarchical linear regression models and Bootstrapping method were used to examine whether subjective support mediated the effectiveness of SS-CBT on depressive symptoms. Participants in SS-CBT group reported significant reduction in depressive symptoms (Wald χ 2 = 20.800, p < 0.001) and improvement in subjective support (Wald χ 2 = 92.855, p < 0.001) compared to those in wait-list control group. Changes in subjective support mediated the effectiveness of SS-CBT on changes in depressive symptoms. Restricted regions to recruit participants, inclusion of the most motivated participants, lack of diagnosis of depression, potential experimenter bias and contamination, short follow-up period, and lack of an active control group. The findings support the benefits of SS-CBT in preventing depression among (pre)frail community-dwelling older adults, and provide insight into possible mechanisms. • (Pre)frail older adults are more likely to experience depression. • Subjective support is effective in protecting depression. • Cognitive behavioral therapy has the potential to improve subjective support. [ABSTRACT FROM AUTHOR]

Discrepancies between sleep diaries and actigraphy occur among individuals with insomnia. Cognitive behavioural therapy for insomnia (CBT-I) improves insomnia but the impact on discrepancy is unclear. This study examined CBT-I's effects on actigraphy-diary discrepancy and explored sleep-related beliefs and attitudes as a mediator. Participants were 108 (age M ± SD = 47.23 ± 12.42, 67.60 % female) adults with insomnia and major depressive disorder from the Treatment of Insomnia and Depression study. They were randomized to 7 sessions of CBT-I or sham Quasi-Desensitization Therapy for Insomnia (DTI), plus 16 weeks of antidepressants. Two weeks of actigraphy and sleep diary were collected at baseline, mid-treatment, end-treatment. Differences between sleep diary and actigraphy total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated. Participants completed Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) at baseline and mid-treatment. At baseline, diary (versus actigraphy) TST was shorter (1.1 ± 1.41h), whilst SOL (21.64 ± 41.25min) and WASO (17.45 ± 61.99min) were longer. Mixed effects models using daily data showed that after adjusting for age and sex, participants in the CBT-I group (versus DTI) showed greater reduction in all actigraphy-diary discrepancy domains (all p-values <.01), reductions evident from mid-treatment. Group differences on actigraphy-diary discrepancy reductions in TST, SOL, and SE (not WASO) were mediated by changes in DBAS from baseline to mid-treatment (all p-values <.05). Changes in discrepancy did not mediate insomnia symptom changes (p-values >.39). CBT-I reduced actigraphy-diary discrepancy in individuals with comorbid insomnia and depression; this reduction was associated with improved sleep-related attitudes, a therapeutic target of CBT-I. TRIAD (Treatment of Insomnia and Depression): Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants. Prospectively registered with Clinical Trials (NCT00767624). MH078924, MH078961, MH079256. • Individuals with insomnia and depression reported shorter and worse sleep compared to actigraphy measures. • CBT-I reduced actigraphy-diary discrepancy in these individuals. • Discrepancy reduction was associated with improved sleep-related attitudes and beliefs. [ABSTRACT FROM AUTHOR]

This paper summarizes the results of the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study and its implications for psychological treatment of adolescents with moderate to severe unipolar major depression. IMPACT was a pragmatic, superiority, randomized controlled trial conducted in the United Kingdom, which compared the clinical and cost-effectiveness of short-term psychoanalytic therapy (STPP), cognitive−behavioral therapy (CBT), and a brief psychosocial intervention (BPI) in reducing depression symptoms in 465 adolescents with unipolar major depression, aged 11 to 17 years. Although this was a clinically heterogeneous group of adolescents, some symptoms (eg, sleep and concentration difficulties, irritability/anger) were common and disabling. The trial reported no significant difference among the 3 treatments in reducing depression symptoms. One year after treatment, 84% of participants showed improvement in depressive symptoms (<50% of baseline symptoms) and improved psychosocial functioning, achieving this through different symptom reduction trajectories. Although participants attended fewer treatment sessions than planned, the 3 treatments were delivered with fidelity to their respective models. Ending treatment without therapist agreement occurred in 37% of cases. This was not associated with outcomes by treatment group. Adolescents emphasized the importance of the therapeutic relationship in all 3 treatments. Results suggest that although most adolescents respond to time-limited, structured psychological therapy, subgroups of depressed adolescents are likely to need additional treatment or support. These include adolescents who live in complex circumstances and/or who believe that their needs are not met in therapy, some who stop treatment early, and the 16% to 18% of adolescents who do not respond to treatment. Improving Mood and Preventing Relapse With Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy; https://www.isrctn.com ; ISRCTN83033550. [ABSTRACT FROM AUTHOR]

Up to 79 % of older adults with depression do not receive treatments commensurate with guideline recommendations. Metacognitive Training-Silver (MCT-Silver) is a low-intensity group training, which aims to reduce depressive symptoms by targeting (meta)cognitive beliefs. A randomized controlled trial comparing MCT-Silver (n = 41) to cognitive remediation (n = 39) was conducted with older adults with major depressive disorder and/or dysthymia. Clinician-rated depression (Hamilton Depression Rating Scale [HDRS, primary outcome]), self-reported depression (Beck Depression Inventory-II [BDI-II]), negative cognitive beliefs, positive metacognitive beliefs, rumination, health status, quality of life, and neurocognitive functioning were assessed at baseline, eight weeks (post) and three months (follow-up). Both groups demonstrated moderate to large reductions in depression. No superior effects of MCT-Silver on clinician-rated depression (HDRS) were detected. MCT-Silver led to greater reductions in self-reported depression and rumination at post- and follow-up. Despite this, scores at post- and follow-up assessments were similar for both groups. MCT-Silver's effect on depressive symptoms was moderated by baseline rumination, positive metacognitive beliefs and previous treatment experience. MCT-Silver was evaluated as superior according to patient appraisals. Conclusions are limited by divergent findings on measures of depression and that the study was conducted during the COVID-19 pandemic. Whereas no superior effect of MCT-Silver was found for the primary outcome, there was a significant effect of MCT-Silver for self-reported depression and rumination. Patients endorsing rumination and positive metacognitive beliefs as well as those without previous psychological treatment may benefit more from MCT-Silver. • We evaluated the efficacy of metacognitive training for depression in later life (MCT-Silver). • 80 patients were randomized to MCT-Silver or a cognitive remediation (CR) group. • MCT-Silver demonstrated statistically significant effects beyond CR on self-reported depression and rumination. • Despite statistically significant effects, total scores at post- and follow-up were similar between groups. [ABSTRACT FROM AUTHOR]

People with HIV (PHW) are at greater risk of depression than the general population. Insight into the time-to-treatment-response and predictors of response to psychotherapy may improve implementation in primary care. We assessed depression treatment response among 80 participants in a trial of cognitive-behavioral therapy for adherence and depression (CBT-AD) for PWH with MDD and suboptimal antiretroviral therapy (ART) adherence. Participants self-reported depressive symptoms (CES D) at each therapy session. Clinicians assessed participants' depression (HAM D), along with potential predictors of response, every four months for one year. Latent class analyses examined classes of responders for the active and the post-treatment phases. Regression analyses identified predictors of class membership for each phase. During the active treatment phase (CES D) we identified an early response (at session 2 and with continued trajectory of improvement) and a non-response group. There were also two classes during post-treatment (HAM-D): early responders (4-month) and late responders (12-month). Distress aversion was associated with lower likelihood of early response to CBT-AD (aOR = 0.74, 95%CI[0.56–0.90], p =.009), and social support was associated with increased likelihood of early response (aOR = 2.24, 95%CI[1.07–5.46], p =.045). Self-reported depression during the treatment phase may have resulted from social desirability bias. Most participants responded to CBT-AD early during treatment (89 %) and had sustained improvements in depression by 4 months (80 %). Distress aversion was a risk factor for late response, and social support was protective. Future research is needed to assess the optimal dose of CBT-AD in resource limited settings. • Cognitive Behavioural Therapy effectively treats depression and adherence in Persons with HIV. It therefore improves rates of viral suppression, more than treatment as usual. • Early self-reported improvements in depression most likely are the result of being in a trial. Improvement continued to occur throughout the acute treatment phase. • Clinician-rated depression over 4, 8 and 12 months also occurred, with steep improvement seen at 4 months. • Whether or not shorter durations of therapy, delivered by nurses, is effective remains to be explored. [ABSTRACT FROM AUTHOR]

The primary objective of this research was to assess the impact of a novel, peer-directed intervention (iNSPiRED) on diabetes distress (DD) among veterans with type 2 diabetes and DD. Secondary objectives were to assess iNSPiRED's impact on anxiety, depression, and diabetes self-management behaviors. A single-blinded, randomized, parallel-group trial was conducted. Participants (n = 218) were recruited through a Veterans Affairs medical center and community agencies in a major metropolitan area from September 2019 through January 2022. Certified mental health peer specialists delivered iNSPiRED, a three-month goal-setting and resource navigation intervention. Outcomes were assessed at baseline, postintervention, and month six. Multilevel random-intercept linear regression models with treatment x time interaction terms were used to assess treatment effects. Frequency of following a healthy eating plan was higher for iNSPiRED vs usual care at month three relative to baseline (B = 0.58; p = 0.03) after adjusting for race and socioeconomic status. No other treatment effects differed significantly from zero (ps ≥ 0.05). Peer-directed interventions have the potential to deliver low-cost, highly scalable care. However, based on the largely negative findings of the current study, it is likely that more intense, multimodal interventions are needed to address DD. • Diabetes distress (DD) is linked to poor diabetes outcomes and quality of life. • A peer-led intervention (iNSPiRED) targeting DD and related outcomes was tested. • iNSPiRED participants improved more in frequency of healthy eating vs usual care. • No other treatment effects differed significantly from zero (ps ≥ 0.05). • More intense, multimodal interventions may be needed to address DD. [ABSTRACT FROM AUTHOR]

To synthesize results of six controlled trials of self-care interventions for depression and/or anxiety, focusing on five trials in which lay guidance was compared to self-directed use of the same self-care tools. The trials were conducted in Canada in different target populations. Self-care tools were adapted to each population. Guidance was provided in 3–15 calls over a period of 6–26 weeks. Depression and/or anxiety were assessed at follow-up (6–26 weeks). Pooled analyses used a meta-analytic approach. Engagement with the self-care tools was compared using the standardized difference or Cohen's d effect size. In studies with homogeneous outcomes (three for depression, four for anxiety), the pooled effect sizes of guidance vs. self-directed use of the self-care tools were 0.36 (95% CI 0.10, 0.62, N = 235) for depression and 0.21 (95% CI -0.03, 0.44, N = 285) for anxiety. Guidance consistently led to greater engagement with the tools. The intervention model is a potentially sustainable and accessible alternative to professionally guided self-care for people with mild-moderate depression. Factors which may have limited implementation success include: co-interventions, reduced number of guide calls (3 vs 6 or more), and delivery to dyads (patient-caregiver). [ABSTRACT FROM AUTHOR]

Transcutaneous auricular vagus nerve stimulation (taVNS) is used for treating depression but the efficacy and safety have not been well assessed. This study was conducted to evaluate the efficacy and safety of taVNS in depression. The retrieval databases included English databases of PubMed, Web of Science, Embase, the Cochrane Library and PsycINFO, and Chinese databases of CNKI, Wanfang, VIP and Sino Med, and the retrieval period was from their inception to November 10, 2022. The clinical trial registers (ClinicalTrials.gov and Chinese Clinical Trial Registry) were also searched. Standardized mean difference and the risk ratio were used as the effect indicator and the effect size was represented by the 95 % confidence interval. Revised Cochrane risk-of-bias tool for randomized trials and the Grades of Recommendation, Assessment, Development and Evaluation system were used to assess the risk of bias and quality of evidence respectively. Totally, 12 studies of 838 participants were included. taVNS could significantly improve depression and reduce Hamilton Depression Scale scores. Low to very low evidence showed that taVNS had higher response rates than sham-taVMS and comparable response rates compared to antidepressants (ATD) and that taVNS combined with ATD had comparable efficacy to ATD with fewer side effects. The number of studies in subgroups was small and the evidence quality was low to very low. taVNS is an effective and safe method for alleviating depression scores and had a comparable response rate to ATD. • taVNS is an effective and safe method for mild to moderate depression. • taVNS has significantly higher response rate than sham-taVNS. • taVNS has comparable effect than antidepressants in reducing Hamilton Depression Scale scores with less side effects. [ABSTRACT FROM AUTHOR]

Unsatisfactory responses to major depressive disorder (MDD) therapeutics available necessitated up-to-date treatment approaches. This study sought to investigate the efficacy and tolerability of adjunctive l -theanine, a green tea constituent with neuropsychotropic effects, for MDD. Sixty MDD (DSM-5) patients were equally assigned to receive sertraline (100 mg/d) plus either l -theanine (200 mg/d) or matched placebo in a six-week randomized, parallel-group, double-blind, placebo-controlled study. The participants were assessed using the Hamilton depression rating scale (HDRS) at baseline and weeks 2, 4, and 6. Changes in scores, early improvement, response and remission rates, and adverse events were compared between the groups. Twenty-five participants in each group, a total of 50 patients, completed the study. All baseline characteristics were similar between the groups. The general linear model repeated-measures analysis demonstrated a significant time-treatment interaction effect for HDRS during the trial (p -value = 0.014), indicating more remarkable symptom improvement in the l -theanine group. A greater reduction in HDRS scores was observed in the l -theanine group from baseline to weeks 2, 4, and 6 (p -values = 0.02, 0.03, and 0.01, respectively). All patients responded to sertraline plus l -theanine until week 6. l -theanine was superior to placebo regarding response to treatment and remission rates at week 6 (p -values = 0.05 and 0.02, respectively). The frequency of side effects was comparable between the groups. The small sample size and short study period were the limitations. l -theanine adjunct to sertraline outperforms placebo in treating MDD in a safe manner. Further long-term, large-scale studies are recommended to confirm this evidence. • l -theanine is an amino acid found naturally in green tea, black tea, and mushrooms. • It is beneficial and tolerable in depression, obtained from a gold-standard design. • l -theanine has been reported to modulate GABA, serotonin, and dopamine levels. • It may also exert effects through the glutamatergic and neuroimmune mechanisms. [ABSTRACT FROM AUTHOR]

Psychotic depression has a high rate of relapse. The study aims were to identify a prediction model of risk of relapse of psychotic depression and examine whether predictors moderated the effect of treatment on relapse. One hundred and twenty-six men and women aged 18–85 years, who experienced sustained remission or near-remission of psychotic depression with sertraline plus olanzapine, participated in a 36-week randomized controlled trial that compared sertraline plus olanzapine with sertraline plus placebo in preventing relapse (NCT01427608). Cox regression analyses were performed to identify significant predictors of relapse and to model the combined role of significant predictors. Concordance statistic was calculated to determine the accuracy of the best fit multivariable models in predicting relapse. Finally, interaction terms were tested for each significant predictor to examine whether they moderated the effect of treatment on risk of relapse. Lifetime number of depressive episodes, severity of residual depressive symptoms at the time of randomization, and psychomotor disturbance both at acute enrollment when participants were depressed and at the time of randomization predicted risk of relapse. Multivariable models had 69–70% accuracy in predicting relapse. Psychomotor disturbance was associated with increased risk of relapse in the sertraline plus olanzapine group compared with sertraline plus placebo, whereas the other predictors did not moderate the effect of treatment on relapse. Future research is needed to determine whether a combination of clinical and biological variables can further increase the accuracy of prediction of relapse of psychotic depression. • Psychotic depression has a high rate of relapse. • Identify predictors and moderators of risk of relapse of remitted psychotic depression. • Lifetime number of depressive episodes, residual depressive symptoms, and psychomotor disturbance predicted relapse. • Multivariable models had 69–70% accuracy in predicting relapse. • Psychomotor disturbance moderated the effect of randomized treatment on relapse. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials (RCTs) of vitamin D (VitD) supplementation for depression have yielded inconsistent results. We conducted the first RCT of VitD supplementation with multipoint serum 25(OH)D assessments in major depressive disorder (MDD) patients with concurrent severe VitD deficiency.Methods: We randomized antidepressant-free depressed adults with mean baseline 25(OH)D of 11.5 ng/ml to VitD (60,000 IU every 5 days; n = 31) or placebo (n = 28) for 12 weeks. All patients also received escitalopram (10-20 mg/day). Patients were rated at baseline and at the end of weeks 4, 8, and 12. Serum 25(OH)D was estimated at baseline, week 8, and week 12.Results: In an intent-to-treat analysis, mean Hamilton Depression Scale scores dropped from 25.7 to 5.7 and from 25.8 to 5.0 in VitD and placebo groups, respectively (primary outcome; P = 0.92). VitD and placebo groups did not differ on other objective and subjective ratings of depression, or on global ratings. Similar findings characterized completer analyses. No significant correlations were observed between 25(OH)D levels and depression ratings across the course of the study. Importantly, endpoint escitalopram doses were 4 mg/day higher in placebo than in VitD patients, and 4 mg/day higher in VitD deficient than in VitD sufficient patients.Limitations: A ceiling effect with escitalopram may have prevented the discovery of benefits with VitD supplementation.Conclusions: VitD supplementation does not improve antidepressant outcomes with flexibly dosed escitalopram. VitD deficient depressed patients may require higher antidepressant doses to experience benefits similar to those whose deficiency is corrected by VitD supplementation. [ABSTRACT FROM AUTHOR]

Several data indicate that the success of pharmacological treatment in major depressive disorder (MDD) is still unsatisfactory. The reasons for the low response and remission rates are multiple and depend on environmental and biological factors intrinsic to the disease and drug treatments. Pharmacogenetic (PG) tests have the potential to increase efficacy predicting outcome and to reduce antidepressant discontinuation due to side effects. Several studies investigated the utility of PG tests for antidepressants in MDD with interesting but contrasting results. To date most of them are observational studies with no comparator group, and few are randomized controlled trials (RCTs). The aim of this review is to provide an evaluation of the state of art on clinical methodologic features of RCTs with PG tests for antidepressant drugs in MDD, offering suggestions and favoring new insights that could be useful in the implementation of future trials. Several limitations concerning study design, generalization of results, duration of trials, patients group studied, and cost-effectiveness ratio were found, and a number of barriers have been noted in the adoption of PG tests into clinical practice. Despite some preliminary positive results, there is the need for larger and longer‐term RCT studies, with the goal to capture the real impact of PG tests, also with stratified analysis concerning MDD features in terms of severity and antidepressant treatment failures in different ethnicity cohorts. [ABSTRACT FROM AUTHOR]

• A home-delivered non-pharmacological intervention contributed to reducing the immediate total and social loneliness of homebound older adults. • The decrease in perceived social loneliness mediated the improvement of depressive symptom levels. • Social loneliness may be a relevant target of intervention to improve depressive symptomatology. The present study aimed to explore whether the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered ten-week cognitive-emotional intervention, was effective in reducing self-reported loneliness among homebound older adults presenting mild cognitive impairment and psychological symptomatology. Effects of HEPPI in total, social, and emotional loneliness, compared with a treatment-as-usual group, were investigated at post-intervention and 3-month follow-up. In addition, the potential role of social and emotional loneliness as mediators of the HEPPI impact on episodic memory and symptoms of depression and anxiety was examined. This study built upon the data of a previously conducted randomized controlled trial. Participants were randomly assigned to the HEPPI group (n = 98) or the treatment-as-usual group (n = 101) and completed baseline, post-intervention, and 3-month follow-up assessments, including measures of loneliness (UCLA - Loneliness scale), episodic memory (Wechsler Memory Scale-III), depressive symptoms (Geriatric Depression Scale-30), and anxiety symptoms (Geriatric Anxiety Inventory). Data were analyzed on an intention-to-treat basis employing linear mixed models and mediation analyses for repeated measures. ClinicalTrials.gov identifier: NCT05499767. Compared with usual care controls, the HEPPI participants reported a significant immediate decrease in total and social loneliness, but these effects were not maintained at a 3-month follow-up. The reduction in immediate perceived social loneliness significantly mediated the improvement of depressive symptoms. The current findings suggest that HEPPI potentially reduced total and social loneliness of the homebound older population immediately post-intervention, and such decrease in social loneliness may be a relevant mechanism for improving their short-term depressive symptomatology. [ABSTRACT FROM AUTHOR]

Mindfulness apps have become popular tools for addressing symptoms of depression and anxiety. Since the publication of earlier meta-analyses evaluating the efficacy of mindfulness apps for depression and anxiety symptoms, over 20 randomized controlled trials (RCTs) have been conducted. There is a need for an updated meta-analysis that quantifies the effects of mindfulness apps on these symptoms and tests for potential moderators.. Random effects meta-analyses were conducted on 45 RCTs. Small, significant effect sizes were found for symptoms of depression (N comp = 46, N = 5852, g = 0.24, 95% CI = 0.17, 0.31, NNT = 13.57) and anxiety (N comp = 48, N = 6082, g = 0.28, 95% CI = 0.21, 0.35, NNT = 11.47) in favour of mindfulness apps over control groups. This effect was not explained by symptom deterioration in participants allocated to control groups. Effects remained stable when restricting analyses to lower risk of bias and larger sample trials. No significant moderators were observed, except trials that offered monetary compensation produced larger effects on depression. Non-significant effects were observed when comparing mindfulness apps to active therapeutic comparisons (g = −0.15 depression, g = 0.10 anxiety), though the number of studies was low. Growing evidence indicates that mindfulness apps can acutely reduce symptoms of depression and anxiety, although higher quality studies with longer follow-ups are needed. • Conducted a meta-analysis of 45 trials of mindfulness apps on depression and anxiety. • Mindfulness apps led to small improvements in depression and anxiety relative to controls. • Mindfulness was not significantly different to active therapeutic comparisons. • Mindfulness apps may help improve symptoms of depression and anxiety to a modest degree. [ABSTRACT FROM AUTHOR]

Background: In spite of numerous options, the most efficacious treatment for major depressive disorder (MDD) remains elusive. Algorithm-guided treatments (AGTs) are proposed to address inadequate remission and optimize treatment delivery. This study aimed to evaluate the clinical benefit of AGTs for MDD, and to explore specific moderators of treatment outcomes for individual patients.Methods: The study recruited 987 patients with MDD across eight hospitals who were randomly assigned to AGT with escitalopram (AGT-E), AGT with mirtazapine (AGT-M), or treatment-as-usual (TAU). The outcomes were symptom remission, response rate, early improvement rate, subsymptom clusters improvement over time, the mean time to first remission, relapse rate at 6-months posttreatment follow-up, quality of life (QOL), and adverse events.Resutls: No significant differences were observed across groups in outcome, except that TAU showed significantly poorer QOL, higher relapse rates at 6-months posttreatment follow-up, and marginally significantly worse maximal burden of adverse events than the AGT groups. After 6 weeks of treatment initiation, remission rate did not significantly increase with extended treatment. AGT-M outperformed the TAU and AGT-E in treating sleep symptoms. AGT-E was less effective than AGT-M and TAU in patients with severe depression and somatic symptoms (DSSS). The superiority of TAU over AGTs was observed in recurrent MDD patients.Conclusion: Although the superiority of AGTs over TAU was limited by failure of alternative subsequent treatment, AGTs outperformed in QOL and relapse rate. Types of disease episode and DSSS were regarded as specific moderators in treatment of depression. These findings might contribute to future research on targeted antidepressant treatment. [ABSTRACT FROM AUTHOR]

Background: There is a need for high-quality research regarding exercise interventions for persons with anxiety disorders. We investigate whether a 12-week exercise intervention, with different intensities, could reduce anxiety symptoms in patients with anxiety disorders.Methods: 286 patients were recruited from primary care in Sweden. Severity of symptoms was self-assessed using the Beck Anxiety Inventory (BAI) and the Montgomery Åsberg Depression Rating Scale (MADRS-S). Participants were randomly assigned to one of two group exercise programs with cardiorespiratory and resistance training and one control/standard treatment non-exercise group, with 1:1:1 allocation.Results: Patients in both exercise groups showed larger improvements in both anxiety and depressive symptoms compared to the control group. No differences in effect sizes were found between the two groups. To study a clinically relevant improvement, BAI and MADRS-S were dichotomized with the mean change in the control group as reference. In adjusted models the odds ratio for improved symptoms of anxiety after low-intensity training was 3.62 (CI 1.34-9.76) and after moderate/high intensity 4.88 (CI 1.66-14.39), for depressive symptoms 4.96 (CI 1.81-13.6) and 4.36 (CI 1.57-12.08) respectively. There was a significant intensity trend for improvement in anxiety symptoms.Limitations: The use of self-rating measures which bears the risk of an under- or overestimation of symptoms.Conclusions: A 12-week group exercise program proved effective for patients with anxiety syndromes in primary care. These findings strengthen the view of physical exercise as an effective treatment and could be more frequently made available in clinical practice for persons with anxiety issues. [ABSTRACT FROM AUTHOR]

Background: Previous studies have indicated that statins can reduce the severity of depressive symptoms. However, the optimal choice of statin remains unclear. Therefore, we conducted a network meta-analysis to determine the optimal statin for treating depression.Method: We performed a pairwise and network meta-analysis by searching the PubMed, Embase, and Cochrane Library databases on October 29th, 2020. Eligible studies were randomized controlled trials that reported on changes in depressive symptoms. The Cochrane Collaboration tool was used to assess risk of bias. We tested for possible inconsistency globally by using a χ2-test and locally by calculating inconsistency factors for each comparison in closed loops. The ranking probabilities of being at each possible rank for each intervention were estimated. Comparison-adjusted funnel plots were obtained to assess publication bias. Sensitivity analysis was also performed.Results: We identified 13 studies that matched our inclusion criteria. The risks of bias were mostly low. None of the global or local tests found significance. Compared with placebo, atorvastatin significantly reduced the severity of depressive symptoms (mean difference -3.46, 95% confidence interval -5.26 to -1.67). Atorvastatin had the first and second rank with probabilities of 44.9% and 39.0%, respectively. Comparison-adjusted funnel plots revealed no significant publication bias.Limitations: Low similarity of included studies and a relative large treatment effect of a single study were observed.Conclusions: In this first network meta-analysis, atorvastatin, with high intensity and a lipophilic effect, was identified as the optimal choice of statin for treating depression. [ABSTRACT FROM AUTHOR]

Background: Meru Health Program (MHP) is a therapist-guided, 8-week intervention for depression delivered via smartphone. The aim was to test its efficacy in patients with clinical depression in a Finnish university student health service.Methods: Patients (n=124, women 72.6%, mean age 25y) were stratified based on antidepressant status, and randomized into intervention group receiving MHP plus treatment as usual (TAU), and control group receiving TAU only. Depression, measured by the Patient Health Questionnaire-9 (PHQ-9) scale, was the primary outcome. After baseline (T0), follow-ups were at mid-intervention (T4), immediately post-intervention (T8); 3 months (T20), and 6 months (T32) post-intervention.Results: The intervention group and control group did not have significant differences in depression outcomes throughout end of treatment and follow-up. Among secondary outcomes, increase in resilience (d=0.32, p=0.03) and mindfulness (d=0.57, p=0.002), and reduction in perceived stress (d=-0.52, p=0.008) were greater in MHP+TAU versus TAU at T32; no differences were found in anxiety, sleep disturbances, and quality of life between groups. Post-hoc comparisons of patients on antidepressants showed significantly greater reduction in depression at T32 for MHP+TAU versus TAU (d=-0.73, p=0.01); patients not on antidepressants showed no between-group differences.Limitations: Limitations include unknown characteristics of TAU, potential bias from patients and providers not being blinded to treatment group, and failure to specify examination of differences by antidepressant status in the protocol.Conclusions: Most outcomes, including depression, did not significantly differ between MHP+TAU and TAU. Exploratory analysis revealed intervention effect at the end of the 6-month follow-up among patients on antidepressant medication. [ABSTRACT FROM AUTHOR]

Background: The treatment effect of multi-component LM interventions on depressive symptoms has not yet been examined.Methods: We systematically searched six databases from inception to February 2020 to identify randomized controlled trials (RCTs) involving any multi-component LM interventions (physical activity, nutritional advice, sleep management, and/or stress management) on depressive symptoms relative to care as usual (CAU), waitlist (WL), no intervention (NI), or attention control (AC) comparisons.Results: Fifty studies with 8,479 participants were included. Multi-component LM interventions reduced depressive symptoms significantly relative to the CAU (p >.001; d = 0.20) and WL/NI (p > .01; d = 0.22) comparisons at immediate posttreatment. However, no significant difference was found when compared with AC. The intervention effects were maintained in the short-term (1- to 3-month follow-up) relative to the CAU comparison (p > .05; d = 0.25), but not in the medium- and long-term. The moderator analyses examining the effect of multi-component LM interventions compared with CAU suggested that the number of lifestyle factors adopted was a significant moderator. Although disease type was not a significant moderator, there was a tendency that the clinical effect of multi-component LM interventions was stronger (d = 0.45) in those diagnosed with major depression. No publication bias was detected.Limitations: Low number of RCTs available in some subgroup analyses prevented from finding meaningful effects. Results may not be extended to major depression, because data on secondary depression were captured.Conclusion: Multi-component LM interventions appeared to be effective in mitigating depressive symptoms; however, the magnitude of the clinical effect was small. Future research is needed to assess more comprehensive and individualized LM interventions which have a greater emphasis on motivational and compliance aspects and focus solely on individuals with depression. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to investigate the effectiveness of a Computer-based Cognitive Behavioral Therapy (CCBT) and identify the characteristics of depressed adolescents that participated in the CCBT program.Methods: Screening tests for depression and help-seeking variables were conducted in school-aged Korean adolescents (n= 376, mean age=15.71 years, 53.7% female). The number of adolescents that scored above the threshold for mild depression (PHQ-9, CES-D) was 139. Fifty adolescents agreed to participate in the randomized controlled trial (RCT) of CCBT program. Twenty-five adolescents were randomly assigned to the treatment group, and the other 25 to the waitlist control group. The treatment group engaged in CCBT with therapeutic support. To identify variables affecting the outcomes, the quality of their homework compliance also was assessed.Results: Participants (n=50) who agreed to participate in the CCBT program demonstrated different help-seeking attitudes - a greater recognition of the need for help and lower interpersonal openness - compared to the adolescents (n=87) who did not participate (t = -2.93, p < .01; t = 3.50, p < .001). The treatment group showed significant improvements in depression, self-esteem, and quality of life compared to the waitlist group. Adolescents with high homework compliance showed a significant decrease in the depression scores compared to adolescents with low homework compliance.Limitations: Small sample size, no follow-up assessments.Conclusion: CCBT could be an effective alternative for depressed adolescents, especially those who tend to have low interpersonal openness. To improve the effects of CCBT, therapeutic support needs to be provided. [ABSTRACT FROM AUTHOR]

Backgrounds: Antidepressants are widely used to treat major depressive disorder. First-line treatments with antidepressants are only successful in one-third of patients; however, evidence from randomized controlled trials on second-line treatments is limited. Moreover, recently acceptability is suggested to be a good indicator of overall treatment success.Methods: This is a multi-center two-arm, three-phased randomized controlled trial performed in Japan from December 2013 to March 2017 comparing the acceptability of escitalopram and duloxetine as a second-line drug. Patients, who failed to respond to antidepressants such as sertraline, paroxetine, fluvoxamine, milnacipran or mirtazapine for at least 3 weeks, were randomized to either escitalopram (Group A) or duloxetine (Group B) in Step 1 (8 weeks). In Step 2 (8 weeks), the drug was switched to the other if the first drug failed. The discontinuation rate at the end of Step 1 was the primary endpoint and non-inferiority of escitalopram vs duloxetine was tested. In addition, change in clinical measures from baseline were also assessed at the end of Step 1, 2 and up to 52 weeks.Results: At the end of Step 1, Group A (n = 82) was significantly superior to Group B (n = 78) in discontinuation rate (4.9% to 19.2%, P = 0.007). The change in clinical indices from baseline were not different between the groups at either timepoint.Limitations: As the major reason for discontinuation in Group B was the "withdrawal of consent" the concrete reason could not be verified.Conclusions: As a second-line treatment drug, escitalopram was suggested to be non-inferior to duloxetine in acceptability.Trial Registration: UMINCTR(UMIN000012367), registered on December 1st, 2013 and last updated on April 4th, 2017. [ABSTRACT FROM AUTHOR]

Background: Patients with unipolar depressive disorder are frequently hospitalized, and the period following discharge is a high-risk-period. Smartphone-based treatments are receiving increasing attention among researchers, clinicians, and patients. We aimed to investigate whether a smartphone-based monitoring and treatment system reduces the rate and duration of readmissions, more than standard treatment, in patients with unipolar depressive disorder following hospitalization.Methods: We conducted a pragmatic, investigator-blinded, randomized controlled trial. The intervention group received a smartphone-based monitoring and treatment system in addition to standard treatment. The system allowed patients to self-monitor symptoms and access psycho-educative information and cognitive modules. The patients were allocated a study-nurse who, based on the monitoring data, guided and supported them. The control group received standard treatment. The trial lasted six months, with outcome assessments at 0, 3, and 6 months.Results: We included 120 patients with unipolar depressive disorder (ICD-10). Intention-to-treat analyses showed no statistically significant differences in time to readmission (Log-Rank p=0.9) or duration of readmissions (B=-16.41,95%CI:-47.32;25.5,p=0.3) (Primary outcomes). There were no differences in clinically rated depressive symptoms (p=0.6) or functioning (p=0.1) (secondary outcomes). The intervention group had higher levels of recovery (B=7,29, 95%CI:0.82;13,75,p=0.028) and a tendency towards higher quality of life (p=0.07), wellbeing (p=0,09) satisfaction with treatment (p=0.05) and behavioral activation (p=0.08) compared with the control group (tertiary outcomes).Limitations: Patients and study-nurses were unblinded to allocation.Conclusions: We found no effect of the intervention on primary or secondary outcomes. In tertiary outcomes, patients in the intervention group reported higher levels of recovery compared to the control group. [ABSTRACT FROM AUTHOR]

Background: A Growing body of literature indicates therapeutic effectiveness of mindfulness for mental disorders. Only few trials have been conducted with schizophrenia spectrum disorders (SSD), mostly in outpatient settings. Primary objective was to assess feasibility, acceptability, and preliminary outcomes of mindfulness-based group therapy (MBGT) for in-patients with SSD.Methods: A pre-registered randomized controlled trial was conducted to assess feasibility and acceptability of the MBGT. The primary outcome was mindfulness measured with the Southampton Mindfulness Questionnaire (SMQ). Secondary outcomes were rater-blinded positive- and negative symptoms, depression, social functioning, and self-reported mindfulness, depression, anxiety, psychological flexibility, quality of life, and medication regime at baseline, post-intervention, and follow-up (Clinical Trails NCT03671005).Results: 40 participants received either treatment-as-usual (TAU; n=19) or (MBGT+TAU; n = 21) for four weeks. At post-intervention, protocol adherence was 95.2%, and retention rate was 95%. ANCOVA revealed significant improvements in the MBGT+TAU for the primary outcome SMQ as well as negative symptoms at post-intervention between groups. In exploratory analyses, secondary outcomes showed medium-to-large pre-to-post-intervention effects on mindfulness, positive-, negative-, and depressive symptoms, psychological flexibility, quality of life, and social functioning for MBGT+TAU and small-to-moderate changes on positive symptoms and social functioning for TAU. No serious adverse effects were reported.Conclusions: MBGT appears feasible and acceptable for in-patient settings, with high protocol adherence and retention rates. Preliminary findings highlight a proof of concept of MBGT and various improvements in clinical- and process dimensions. A fully powered trial is warranted to determine efficacy, cost-efficiency, and longitudinal changes based on these promising outcomes. [ABSTRACT FROM AUTHOR]

• Modernized collaborative care for depression did not change plasma BDNF. • Modernized collaborative care improved depressive symptom clusters. • Changes in BDNF did not mediate the intervention effect on either symptom cluster. • Other mechanisms are responsible for the beneficial intervention effects. Brain-derived neurotrophic factor (BDNF) levels are lower in people with depression and are normalized following pharmacological treatment. However, it is unknown if psychological treatments for depression improve BDNF and if change in BDNF is a mediator of intervention effects on depressive symptoms. Therefore, using data from the eIMPACT trial, we sought to determine the effect of modernized collaborative care for depression on 12-month changes in BDNF and cognitive/affective and somatic depressive symptom clusters and to examine whether BDNF changes mediate intervention effects on depressive symptoms. 216 primary care patients with depression from a safety net healthcare system were randomized to 12 months of the eIMPACT intervention (internet cognitive-behavioral therapy [CBT], telephonic CBT, and select antidepressant medications) or usual primary care. Plasma BDNF was measured with commercially available kits, and depressive symptom clusters were assessed by the Patient Health Questionnaire-9. The intervention did not influence BDNF but did improve both the cognitive/affective and somatic clusters over 12 months. Changes in BDNF did not mediate the intervention effect on either cluster. Our findings suggest that modernized collaborative care is an effective treatment for both the cognitive/affective and somatic symptoms of depression and that the mechanism of action is not improvements in BDNF. ClinicalTrials.gov Identifier: NCT02458690 [ABSTRACT FROM AUTHOR]

Depression is a recognized barrier to heart failure self-care, but there has been little research on interventions to improve heart failure self-care in depressed patients. To investigate the outcomes of an individually tailored self-care intervention for patients with heart failure and major depression, and to determine whether the adequacy of self-care at baseline, the severity of depression or anxiety, or other factors affect the outcomes of this intervention. Secondary analysis of data from a pre-registered randomized controlled trial (NCT02997865). Outpatients with heart failure and comorbid major depression (n = 139) were randomly assigned to cognitive behavior therapy or usual care for depression. In addition, an experienced cardiac nurse provided the tailored self-care intervention to all patients in both arms of the trial starting eight weeks after randomization. Weekly self-care intervention sessions were held between Weeks 8 and 16; the frequency was tapered to biweekly or monthly between Weeks 17 and 32. The Self-Care of Heart Failure Index (v6.2) was used to assess self-care outcomes, with scores ≥ 70 on each of its three scales (Maintenance, Management, and Confidence) being consistent with adequate self-care. The Week 16 Maintenance scale score was the primary outcome for this analysis. At baseline, 107 (77%) of the patients scored in the inadequate self-care range on the Maintenance scale. Between Weeks 8 and 16, Maintenance scores improved more in patients with initially inadequate than initially adequate self-care (11.9 vs. 3.2 points, p =.003). Sixty-six (48%) of the patients with initially inadequate Maintenance scores achieved scores in the adequate range by Week 32 (p <.0001). Covariate-adjusted predictors of better Maintenance outcomes included adequate Maintenance at baseline (p <.0001), higher anxiety at baseline (p <.05), and higher dosages of the self-care intervention (p <.0001). Neither treatment with cognitive behavior therapy nor less severe major depression predicted better self-care outcomes. Depressed patients with inadequate heart failure self-care are able to achieve clinically significant improvements in self-care with the help of an individually tailored self-care intervention. Further refinement and testing are needed to increase the intervention's potential for clinical implementation. [ABSTRACT FROM AUTHOR]

Emotion regulation therapy (ERT) promotes resilience in distress disorders by strengthening attentional and metacognitive capacities. Regulation skills are presented with the goal of ameliorating the perseverative negative thinking (PNT) that characterizes these disorders. This study tested ERT in a randomized controlled trial comparing the effectiveness of 16-session (ERT16) versus 8-session (ERT8) doses. Patients (N = 72) endorsing elevated worry and/or rumination and meeting diagnostic criteria for a distress disorder were randomized to ERT8 or ERT16. PNT, anxiety/depressive symptoms, functioning/quality of life, and treatment mechanisms (attention shifting, attention focusing, decentering, reappraisal) were measured at pre, mid, and post treatment. Clinical symptom severity was also assigned via diagnostic interview at each timepoint. ERT produced significant improvements across outcomes. ERT16 showed an advantage over ERT8 for distress disorder severity, worry, rumination, and attention shifting from pre-post treatment. Changes in ERT treatment mechanisms mediated changes in clinical improvement. These findings provide evidence of the effectiveness of two doses of ERT in reducing PNT and distress through improvements in regulation skills. NCT04060940. • Emotion regulation therapy (ERT) was tested in an 8-and 16-session format. • Distress-related outcomes and mechanisms were measured at pre, mid, and post treatment. • ERT improved mechanisms and distress-related outcomes through post treatment. • ERT16 was favorable compared to ERT8 across several outcomes. • Indices of attentional and metacognitive regulation mediated these changes. [ABSTRACT FROM AUTHOR]

Background: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.Methods: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.Results: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.Limitations: Results are limited to green professions and representativeness might be restricted by self-selection of participants.Conclusion: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.Trial Registration: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018. [ABSTRACT FROM AUTHOR]

Background: This report seeks to evaluate improvements in symptoms of irritability with sertraline (a selective serotonin reuptake inhibitor antidepressant) versus placebo.Methods: Participants of Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study who were randomized to 8 weeks of treatment with either sertraline or placebo and completed 5-item irritability domain of Concise Associated Symptom Tracking scale (CAST-IRR) at baseline were included (n = 292). Repeated measures mixed model analysis with CAST-IRR as the outcome variable and treatment arm-by-time interaction as the independent variable of interest evaluated whether changes in irritability with treatment differed between sertraline and placebo arms. A separate analysis controlled for levels of overall depression severity (17-item Hamilton Depression Rating Scale). Covariates included age, sex, race, ethnicity, and site.Results: There was a significant treatment arm-by-time interaction (F = 6.96, df = 6, 1418, p <0.0001) suggesting that changes in irritability with sertraline differed from placebo. The magnitude of reduction in irritability from baseline to week-8 was greater with sertraline than with placebo (Cohen's d effect size = 0.56). After controlling for levels of overall depression severity at each visit, reduction in irritability with time continued to be significant with sertraline but not with placebo.Limitations: Secondary analysis, limited generalizability, lack of non-serotonergic antidepressants.Discussion: There is greater improvement in irritability with sertraline than with placebo. Improvement in irritability with sertraline was independent of its effects on overall depression severity. CLINICALTRIALS.Gov Identifier: NCT01407094. [ABSTRACT FROM AUTHOR]

Adjunctive vitamin D replacement is a theoretically promising strategy to improve outcomes in major depression. Our objective was to assess the efficacy of a single parenteral dose of vitamin D supplementation at baseline as an adjunct to treatment as usual on change in depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes) at the end of 12 weeks when compared to treatment as usual in patients with major depression and concurrent Vitamin D deficiency. Eligible participants were randomized to receive either treatment as usual (TAU; n = 23) or TAU plus single parenteral dose of 3,00,000 IU of vitamin D (n = 23) at baseline. Rater-blinded assessments of depression (primary outcome), quality of life (QoL) and clinical severity of illness were obtained at baseline, and end of follow-up (12 weeks). Intent-to-treat analyses were performed on the entire randomized sample. The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase. These findings indicate that a single parenteral dose (3,00,000 IU) of adjunctive vitamin D replacement at baseline is an effective and well tolerated intervention in major depressive disorder with concurrent Vitamin D deficiency. Additionally, it points to a possible role for vitamin D in the pathophysiology of depression and supports personalized approaches for treatment of major depressive disorder. • A single intramuscular dose of adjunctive vitamin D at baseline was effective in improving clinical depression ratings. • The intervention also improved quality of life and clinical severity of illness. • Adjunctive vitamin D may be an effective step-up strategy for management of major depression with vitamin D deficiency. [ABSTRACT FROM AUTHOR]

We compared the efficacy and safety of transcranial direct current stimulation (tDCS) vs. Sertraline in the treatment of Major Depressive Disorder (MDD) in South Korean participants. This was a multi-center, double blind, active controlled study with non-inferiority testing. Patients were randomly assigned to receive tDCS (n = 45) or Sertraline (n = 47). tDCS was administered in 30-min, 2 mA prefrontal stimulation sessions for 10 consecutive weekdays, followed by 2 treatments at 4 and 6 weeks. Sertraline was administered at a dose of 50 mg per day for 6 weeks. The primary outcome measure was a change in the Montgomery-Asberg Depression Rating Scale (MADRS) score at six weeks. Mean MADRS scores decreased by 14.58 ± 8.51 points in the tDCS group and 12.32 ± 8.56 points in the Sertraline group. There was no significant main effect of group (p = 0.5877) or time by group interaction across weeks 0, 3, and 6 (p = 0.1539). Noninferiority of tDCS compared with Sertraline was not demonstrated. The mean difference between the Sertraline and tDCS group was −2.258 (95% confidence interval [CI], −5.795 to 1.27811), and the lower boundary of the CI was lower than the prespecified noninferiority margin of −3.56. There were no significant group differences in the rate of adverse events. In the present study, the noninferiority of tDCS to Sertraline for the treatment of depression was not found in this Korean population. [ABSTRACT FROM AUTHOR]

Background: Evidence for antidepressant effects of L-Carnosine was shown in some experimental studies. In this study we tried to evaluate the efficacy and tolerability of L-Carnosine combination therapy in treatment of patients with major depressive disorder (MDD).Methods: Fifty-eight patients with MDD (DSM-V) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 400 mg twice daily L-Carnosine or placebo in addition to citalopram (maximum dosage of 40 mg/day) for six weeks in a randomized double-blind, and placebo-controlled study. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6.Results: Fifty-two patients completed the trial. General linear model repeated measure showed significant difference for time × treatment on HAM-D score [F = 3.17, df = 2.39, p-value = 0.03]. Significantly greater improvement was detected in HAM-D score of the L-Carnosine group compared with the placebo group from baseline to weeks 2, 4 and 6 [Ps = 0.013, 0.028 and 0.023; respectively]. Patients in the L-Carnosine group experienced significantly greater response and remission rate than the placebo group [Ps = 0.023 and 0.012; respectively]. There was no significant difference between the two groups in baseline parameters and frequency of side effects.Limitations: Short follow-up period and small population size were two important limitations of this study.Conclusions: L-Carnosine combination therapy with citalopram can effectively improve symptoms of patients with major depressive disorder. Rapid-onset antidepressant effects of L-Carnosine were also shown which need further investigation. [ABSTRACT FROM AUTHOR]

Background: Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose.Method: We recruited 98 patients with MDD (aged 18-65 years). After 4 weeks of open-label treatment with 10-20 mg of escitalopram per day, non-remitters [Montgomery-Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score.Results: After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88%) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [-8.0 (1.2) in the placebo dose-escalation and -11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences.Limitations: Small sample size and short follow-up period CONCLUSION: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10-20 mg/day) treatment. [ABSTRACT FROM AUTHOR]

Depression following acute coronary syndrome is prevalent and associated with increased mortality and morbidity. Melatonin may function as a primary prophylactic antidepressant substance and alleviate depressive symptoms. The study was undertaken to determine if melatonin administered following an acute coronary syndrome (ACS) could prevent development of depression. The study was a double-blinded, placebo-controlled, multicenter, randomized clinical trial performed in five primary care cardiology departments at Zealand, Denmark. Included patients were adults patients, free of depression at baseline, included at the latest 4 weeks after acute coronary syndrome. Twenty-five mg melatonin or placebo was administered 1 h before participants' bedtime for 12 weeks. The primary outcome is Major Depression Inventory (MDI) measured every two weeks throughout the trial. Incidence of depression was apriori defined as MDI score ≥ 21 during the trial. Reported exploratory outcomes were patterns of dropout and safety outcomes. 1220 patients were screened and 252 participants were randomized in a 1:1 ratio. Baseline MDI score in the melatonin and placebo group were, respectively, 6.18 (CI 5.32–7.05) and 5.98 (CI 5.19–6.77). No significant intergroup differences were found during the study in the intention-to-treat analysis or per-protocol analysis. Cumulative events of depressive episodes during the 12 weeks were six in the melatonin group and four in the placebo group. A significant drop in depressive symptoms were present throughout the study period. No intergroup differences were present in dropouts or adverse events. Melatonin showed no prophylactic antidepressant effect following acute coronary syndrome. The non-significant results might be due to a type II error or melatonin might not be able to prevent development of depressive symptoms following ACS. [ABSTRACT FROM AUTHOR]

Pain and depression frequently co-occur among older adults with comorbidities and can exacerbate one another. The intersection of race, gender and age puts older African American women at high risk of experiencing comorbid pain and depression. The purpose of this study is to test the feasibility and acceptability of a 12-week behavioral activation intervention called DAPPER (Depression and Pain Perseverance through Empowerment and Recovery) that uses non-pharmacological, tailored strategies to target pain and mood symptoms. We will measure pain intensity and depressive symptoms as outcomes, although we are not powered to test differences. We describe the protocol for this study that uses a randomized waitlist control design to examine acceptability and feasibility of an intervention. The study population is comprised of self-identified African American women, 50 years of age or older with chronic pain and who self-report of depressive symptoms. Participants must also be pre-frail or frail and have an ADL or IADL limitation. The intervention consists of eight 1–2-h visits with a nurse interventionist via in-person or virtual telecommunication methods and two visits for non-invasive specimen collection. The primary outcomes include goal attainment, pain and depressive symptoms. Secondary outcomes include stress, frailty, and communication with providers. Follow-up qualitative interviews are conducted with participants to assess intervention acceptability. Findings from this pilot study will provide further evidence supporting the use of non-pharmacological techniques to intervene in the cycle of pain and depression among an at-risk sub-population. [ABSTRACT FROM AUTHOR]

• PTSD with MDD is common and can cause impairment among active duty service members. • Compared CPT with behavioral activation versus CPT alone. • Significant improvements in depression and PTSD outcomes in both treatments. • Attendance and patient satisfaction ratings were high in both treatment conditions. • Both treatments may be effective psychotherapy options for comorbid PTSD and MDD. Posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) frequently co-occur and can cause significant impairment. Data are lacking as to whether interventions targeting both PTSD and MDD may improve treatment outcomes among individuals with this comorbidity compared with existing evidence-based PTSD treatments alone. This randomized trial compared the effectiveness of cognitive processing therapy (CPT) enhanced with behavioral activation (BA+CPT) versus CPT among 94 service members (52 women and 42 men; age M = 28.5 years) with comorbid PTSD and MDD. The primary outcome was clinician-administered depression symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS) from pretreatment through 3-month follow-up. Intent-to-treat analyses using multilevel models showed statistically and clinically significant decreases in MADRS scores for both conditions over time, with no significant differences between BA+CPT and CPT. Secondary depression and PTSD symptom outcomes followed a similar pattern of results. For diagnostic MDD and PTSD outcomes using available data, no statistically significant differences between treatments emerged at posttreatment or 3-month follow-up. Sessions attended, dropout rate, and treatment satisfaction did not significantly differ between treatments. Outcomes were comparable for both treatments, suggesting that BA+CPT and CPT were similarly effective psychotherapy options for comorbid PTSD and MDD. [ABSTRACT FROM AUTHOR]

Abstract Background We tested the associations of a lifestyle multidomain intervention (MI), omega-3 supplementation (O3) or their combination with the change of clinically meaningful depressive symptoms in older adults. Methods Secondary analysis of the 3-year Multidomain Alzheimer Preventive Trial (MAPT), in which 1679 people, ≥70 years with memory complaints were randomized into: MI, O3, MI + O3, or placebo. MI was composed of nutritional and physical activity counselling and cognitive training. O3 supplementation corresponded to a daily dose of 1000 mg of omega-3. Discrete-time cox regressions were performed for each outcome. Three binary variables of incidence of depressive symptoms were created from the 15-item geriatric depression scale (GDS-15): minimum clinically meaningful depressive symptoms (≥2-point increase in GDS-15), moderate depressive symptoms (GDS-15 ≥ 5), and severe depressive symptoms (GDS-15 ≥ 10) DS. Results Discrete-time cox proportional hazards have found no associations for all of the analysis. The incidence of severe depressive symptoms across groups were, respectively: 1.1, 2.4, 2.3 and 2.5 per 100 person year for MI + O3, for O3, for MI, for placebo. There was a trend for a decreased risk of developing severe DS compared to placebo in the MI + O3 group (p = 0.085 after adjustment). Conclusions To conclude, we did not find any association of a lifestyle multidomain intervention with the onset of clinically depressive symptoms in older adults with memory complaints. A study with a more intensive multidomain intervention might bring further insights on this topic. Highlights • First study to use clinical cut-offs in a multidomain intervention; • We performed subgroup analysis on individuals who are at risk of cognitive impairment. • A trend was observed in reducing the risk for severe depressive symptoms. [ABSTRACT FROM AUTHOR]

Background: Defense mechanisms play an important role in the development and maintenance of both health and psychopathology. Research is still in the early stages of investigating the specific relationships among diagnostic groups and defense mechanisms along with their response to different treatment types.Methods: For the present study a total of 47 outpatients diagnosed with depression or anxiety disorders were randomized to receive 25±3 sessions of cognitive-behavioral therapy with integrated elements of either emotion-focused therapy (CBT + EFT) or treatment components based on self-regulation theory (CBT + SR). An observer-rated method, the Defense Mechanism Rating Scale (DMRS) was used to code transcripts of the 1st, 8th, 16th and 24th session to assess change in defensive functioning.Results: Over the course of therapy, overall defensive functioning (ODF) as well as adaptive defenses increased significantly, whereas maladaptive and neurotic defenses did not change. At the beginning of treatment, the proportion of adaptive defenses and ODF was significantly higher in patients diagnosed with anxiety disorders than in patients with depressive disorders. However, depressed patients exhibited greater improvement in their defensive functioning over the course of therapy.Conclusions: Results support the view of defense mechanisms as a useful transdiagnostic and transtheoretical concept and supports the notion that change of defense mechanisms may be a relevant mechanism of change in psychotherapy. [ABSTRACT FROM AUTHOR]

• Psychotherapy is widely believed to impact biology, but most evidence is observational. • We systematically reviewed all trials of psychotherapy for depression that assessed biomarkers. • For glycaemic control and cortisol concentration psychotherapy did not outperform control. • Across a range of biomarker domains, findings were mixed or inconsistent. • The beneficial effects of psychotherapy for depression symptoms do not translate to biomarkers. Though it is widely believed that psychotherapy changes biology, this contention is largely based on observational data, subject to confounding. We report the first systematic review and meta-analysis of biological variables assessed, as outcomes or predictors of response, in randomized controlled trials of psychotherapy for adult depression. Fifty-one trials (5123 participants) and a pooled analysis were included. Biological markers were outcomes in 43 studies and predictors of treatment response in 9. At post-treatment, psychotherapy could not be distinguished from control conditions for glycaemic control (Hb1AC), 7 trials, Hedges' g = -.01, 95% CI -0.30 to 0.29, I2 = 65% and cortisol concentration after-wake, 5 trials, Hedges' g = -.19, 95% CI -0.45 to 0.06, I2 = 0%. Follow-up results were similar. For the other biological domains (immunological, neurobiological, inflammatory, weight, blood pressure), overall findings were mixed and often inconsistent. Few trials investigated prediction of response, with only neuroimaging markers showing promise. Across domains, we found limited evidence that benefits of psychological treatments for depression translate to biological outcomes. [ABSTRACT FROM AUTHOR]

Background: Training in interoceptive awareness is a promising behavioral approach for improving substance use disorder (SUD) treatment. This study examined the longitudinal effects of Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to women's SUD treatment. MABT teaches interoceptive awareness skills to promote self-care and emotion regulation.Methods: Women in intensive outpatient treatment for SUD at three community clinics were recruited and randomly assigned to one of three study conditions Treatment as Usual (TAU) + MABT, TAU + Women's Health Education (WHE), and TAU only. Four assessments were delivered over one year (N = 187) baseline, 3, 6 and 12 months to examine primary outcome of percent days abstinent from substance use, and secondary outcomes of emotion dysregulation, craving, psychological distress, mindfulness and interoceptive awareness. Changes in outcomes across time were assessed using multilevel mixed effects linear regression.Results: Substance use improved significantly for MABT vs. TAU at 6 months and 12 months. Positive longitudinal effects on secondary outcomes for MABT were evident on respiratory sinus arrhythmia (RSA), a physiological index of emotion regulation; on craving; and on interoceptive awareness skills. Analyses based on participants who completed >75% of the intervention sessions revealed additional immediate significant improvements for MABT vs. TAU and WHE on depressive symptoms and emotion regulation difficulties and longitudinal improvement on mindfulness skills.Conclusions: Results show MABT to be efficacious for longitudinal health outcomes to support women's recovery as an adjunct to community-based SUD treatment. [ABSTRACT FROM AUTHOR]

Background: Suicide prevention is a core task in mental health services. Our objective was to determine whether Collaborative Assessment and Management of Suicidality (CAMS) reduced suicidal thoughts and behaviors and mental health distress more effectively than treatment as usual (TAU) in a heterogeneous patient population within specialized mental health care services.Methods: In this observer-blinded pragmatic randomized controlled trial participants who scored 13 or above on Beck's Scale for Suicide Ideation-Current (BSSI-C) were included from seven in- and outpatient units. Primary outcome was suicidal ideation (BSSI-C). Secondary outcomes were mental health distress measured by the Outcome Questionnaire-45, and suicidal behaviors measured by the Suicide Attempt Self-Injury Count. Patients were assessed at baseline and after 6 and 12 months.Results: The final intent-to-treat analyses included 78 participants (mean age 35.9 years, SD = 14.5, 41 females). The majority were depressed (65%), had a secondary diagnosis (73%) and 32% suffered from borderline personality disorder or borderline traits. After 6 months, CAMS participants reported lower levels of suicidal ideation compared to TAU (β = -4.29, 95% CI = -8.32 to -0.27, p = .036). Larger changes in mental health distress were observed for CAMS participants after 6 months (β = -11.87, 95% CI = -22.99 to -0.76, p = .036) and 12 months (β = -13.70, 95% CI = -24.88 to -2.51, p = .017).Limitations: The modest sample size rendered the trial unable to detect small between-group differences.Conclusions: CAMS reduced suicidal ideation and mental health distress more efficiently than TAU in a heterogeneous patient population within specialized care. [ABSTRACT FROM AUTHOR]

Abstract Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. Unfortunately, evidence-based psychosocial therapies typically focus on single disorders, are rarely adopted by community mental health center clinicians, and effect sizes are modest. This article describes the protocol for a comparative effectiveness study of two novel interventions designed to address these challenges. The first intervention is a transdiagnostic treatment (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents, UP-A), a promising new approach that uses a small number of common strategies to treat a broad range of emotional disorders, and their underlying shared emotional vulnerabilities. The second intervention is a standardized measurement feedback system, the Youth Outcomes Questionnaire (YOQ), designed to improve clinical decision making using weekly symptom and relational data. The three study arms are treatment as usual (TAU), TAU plus the YOQ (TAU+), and UP-A (used in combination with the YOQ). The primary aims of the study are to [1] compare the effects of the UP-A and TAU+ to TAU in community mental health clinics, [2] to isolate the effects of measurement and feedback by comparing the UP-A and TAU+ condition, and [3] to examine the mechanisms of action of both interventions. Design considerations and study methods are provided to inform future effectiveness research. [ABSTRACT FROM AUTHOR]

Background: Depression is a prevalent disorder with a peak rate of onset in young adulthood from 18 to 25 years. To date, no review has systematically assessed the effectiveness of programs that aim to reduce depressive symptoms or diagnosis of depression in young adults.Method: A systematic search was performed in Cochrane, PubMed, PsycINFO and EMBASE. We performed a random-effects meta-analysis of the randomized controlled studies that compared an intervention for young adults (aged 18-25) without a diagnosis or history of depression and a control condition. Comparisons between intervention and control group outcomes were carried out at the post-intervention time point. We also compared intervention and control group outcomes at later follow-up time points where data were available.Results: Twenty-six randomized controlled trials among 2865 young adults were included in the analysis. The pooled effect size of the interventions versus control at post-intervention was g = 0.37 (95% CI: 0.28-0.47, NNT = 9) and heterogeneity was moderate I2 = 36 (95% CI: 11-64). There were no significant effects in terms of the type of delivery, focus of study, type of control, or type of support within the interventions.Limitations: The authors were unable to assess the effects of interventions on the onset of depression as none of the included studies measured incidence. The risk of bias was high in most studies (81%). Only one study included a follow-up of more than a year. Demographic factors were inconsistently reported in the included articles.Conclusion: While it was not possible to investigate the effects of interventions on depression incidence, some evidence was found for the effectiveness of preventative interventions in reducing depressive symptoms in young adults. Future research should address limitations of the current evidence base to allow stronger conclusions to be drawn. [ABSTRACT FROM AUTHOR]

Background: Self-guided computerized cognitive behavior therapy (cCBT) has the potential to be a feasible alternative to current first-step treatment approaches for depression. Yet, research regarding the effectiveness and acceptability of self-guided cCBT as an adjunct element of GP care is controversial.Methods: Primary care patients with symptoms of mild to moderately severe depression (N = 647) were recruited from 112 GP practices within a cluster randomized controlled trial. GPs were randomized to groups that provided either cCBT (internet intervention) plus treatment as usual (TAU) or TAU alone. Primary outcomes were self-reported depression severity according to the Beck Depression Inventory (BDI-II) and Patient Health Questionnaire (PHQ-9). Intention to treat (ITT) and per protocol (PP) analysis was performed.Results: ITT analyses showed significant between group differences in depressive symptoms for BDI-II in favor of the intervention group, corresponding to a small effect size (6 weeks: d = 0.36, 95% CI 0.19 to 0.53, P < .001; 6 months: d = 0.41, 95% 0.22 to 0.59, P < .001). The number needed to treat (NNT) at six months was 6.2. PHQ-9 analyses was solely significant at six months (d = 0.26, 95% CI 0.08 to 0.44, P < .05, NNT = 9.2). PP analyses highly agree with these findings.Limitations: The initial response rate with regard to the recruitment of GP practices for the trial was low.Conclusions: The results suggest that cCBT is effective in reducing depressive symptoms in mildly to moderately severe depressed primary care patients. Efforts should be made to raise awareness about the potential of such freely accessible treatment options among GPs and patients. [ABSTRACT FROM AUTHOR]

Abstract Background People typically seek primary health care for daytime symptoms and impairments they experience in association with their insomnia. However, few studies address the question of whether insomnia treatment can improve such symptomatology. Objectives To investigate whether a nurse-led group treatment program, based on the techniques of cognitive behavioral therapy for insomnia (CBT-I), improved daytime symptomatology in primary care patients with insomnia. Outcomes Fatigue (Fatigue Severity Scale [FSS]; main outcome), mood (General Health Questionnaire and Montgomery-Asberg Depression Rating Scale), health-related quality of life (Short-Form Health Survey), general daytime functioning, specific daytime symptoms (individual items from the Insomnia Severity Index and Uppsala Sleep Inventory), and dysfunctional beliefs (Dysfunctional Beliefs and Attitudes about Sleep). Design A randomized controlled trial including baseline and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Settings Seven primary health care centers (Stockholm, Sweden). Participants One hundred and sixty-five primary care patients who meet the criteria for insomnia disorder (mean age 54 years, SD 16). Most were women (73%). Exclusion criteria: severe untreated illness, bipolar disorder, current stressful life event, night shift work, and untreated sleep disorder other than insomnia. Methods Data came from a randomized controlled trial of a 10-week nurse-led group treatment for insomnia based on CBT-I (n = 90). The control condition was treatment as usual (n = 75). In accordance with intention-to-treat principles, analyses included data on patients who completed baseline assessments (intervention n = 82, and control group n = 71; post-treatment dropout rate 20%). Fifty-four patients were included in the 1-year follow-up. Results Fatigue severity improved significantly more (p < 0.001) in the intervention than in the control group (intervention, total FSS score 37.2 [SD 11.9] to 31.0 [SD 13.4] vs. control 35.9 [SD 12.1] to 35.7 [SD 12.8]). This was true also for measurements on mood (psychological distress and depressive symptoms), health-related quality of life (mental functioning), general daytime functioning, specific daytime symptoms (worry about sleep, sleepiness, bodily tiredness, and difficulty concentrating) and dysfunctional beliefs. All improvements were maintained one year after group treatment. Conclusions Many aspects of the daytime symptomatology of insomnia were improved via nurse-led group treatment based on CBT-I in primary health care. [ABSTRACT FROM AUTHOR]

Objective: The relationship between attachment orientations and the recovery from depressive symptoms in patients diagnosed with coronary artery disease (CAD) with and without a psychotherapeutic intervention was examined in this study.Methods: In a multicenter trial of 570 depressed CAD patients (SPIRR-CAD), assigned to usual care plus either a stepwise psychotherapy intervention or one information session, 522 patients provided attachment data at baseline. Attachment was measured with the Relationship Scales Questionnaire (RSQ), yielding four attachment orientations. The primary outcome was change in Hospital Anxiety and Depression Scale depression (HADS-D) scores from baseline to follow-up at 18 months. Secondary outcomes were HADS-D scores at 1, 6, 12, and 24 months.Results: Independent of treatment assignment, attachment was related to change in depression at 18 months (p < 0.01) with secure attachment resulting in a significant reduction (-2.72, SE = 0.27) in depression compared to dismissive-avoidant (-1.51, SE = 0.35, p = 0.040) and fearful-avoidant (-0.65, SE = 0.61, p = 0.012) attachment. Patients with anxious-preoccupied attachment showed changes similar to secure attachment (-2.01, SE = 0.47). An explorative subgroup analysis across all assessment time points revealed patients with a dismissive-avoidant attachment benefitted from psychotherapy (average mean difference = 0.93, SE = 0.47, p = 0.048).Conclusion: Attachment played an important role for improvement in depressive symptoms. Only dismissive-avoidant patients seemed to benefit from the intervention. The lack of improvement in fearful-avoidant patients shows a need for specific interventions for this group.Trial Registration: www.clinicaltrials.govNCT00705965; www.isrctn.com ISRCTN76240576. [ABSTRACT FROM AUTHOR]

The Exercise Program in Cancer and Cognition (EPICC) Study is a randomized controlled trial designed to test the effects of moderate-intensity aerobic exercise on cognitive function in postmenopausal women with early-stage breast cancer during the first six months of aromatase inhibitor therapy. It is estimated that up to 75% of survivors of breast cancer experience cognitive impairment related to disease and treatment. At present, there are no known interventions to improve or manage cognitive function for women with breast cancer. Here, we describe a single-blinded, randomized controlled trial with allocation of 254 postmenopausal women with early-stage breast cancer to a supervised six-month aerobic exercise intervention or usual care. Prior to beginning aromatase inhibitor (AI) therapy, participants complete baseline assessments of cognitive function, cardiorespiratory fitness, blood-based biomarkers, physical activity and sleep, and symptoms (fatigue, sleep problems, depressive symptoms, anxiety). A random subset of participants (n = 150) undergoes neuroimaging procedures that include structural and functional magnetic resonance imaging assessments. All participants maintain an activity diary; physical activity and sleep monitoring is repeated three and seven months post-randomization. The remaining baseline assessments are repeated seven months post-randomization. If successful, exercise could be a low-cost method to improve cognitive function in women with breast cancer that is easily adaptable to the home or community. Trial registration: Clinicaltrials.gov NCT02793921 . Registered 20 May 2016. [ABSTRACT FROM AUTHOR]

Background Exercise is an effective treatment for depression but non-adherence is common. The aim of this study was to determine the level of adherence to an exercise intervention, specifically factors associated with adherence in a depressed population. Methods This study reports the secondary analysis from a randomized controlled trial. The 310 participants were aged 18–67 years and affected by mild to moderate depression i.e. scoring ≥10 on the Patient Health Questionnaire-9 (PHQ-9). Adherence to an exercise intervention (light, moderate, vigorous, performed three times a week for 12 weeks) was measured using pulse watches or self-reports (78.4% vs. 21.6%). Factors associated with adherence were explored using negative binomial regression models. Results Adherers (≥12 sessions, 32.7%) exercised on average 22.9 (SD = 7.4) times, while sub-adherers (1–11 sessions, 26.9%) attended on average 4.7 (SD = 3.1) sessions. Around 40% of participants were non-adherers (0 sessions). Tobacco use and hazardous alcohol use were associated with a lower adherence while flexibility at work was associated with higher adherence. Conclusion Tobacco use, hazardous alcohol use and flexibility at work can influence adherence to an exercise program among depressed people and should be considered when applying exercise interventions. [ABSTRACT FROM AUTHOR]

We examined whether electroconvulsive therapy (ECT) plus medications (“STABLE + PHARM” group) had superior HRQOL compared with medications alone (“PHARM” group) as continuation strategy after successful acute right unilateral ECT for major depressive disorder (MDD). We hypothesized that scores from the Medical Outcomes Study Short Form-36 (SF-36) would be higher during continuation treatment in the “STABLE + PHARM” group versus the “PHARM” group. The overall study design was called “Prolonging Remission in Depressed Elderly” (PRIDE). Remitters to the acute course of ECT were re-consented to enter a 6 month RCT of “STABLE + PHARM” versus “PHARM”. Measures of depressive symptoms and cognitive function were completed by blind raters; SF-36 measurements were patient self-report every 4 weeks. Participants were 120 patients >60 years old. Patients with dementia, schizophrenia, bipolar disorder, or substance abuse were excluded. The “PHARM” group received venlafaxine and lithium. The “STABLE + PHARM” received the same medications, plus 4 weekly outpatient ECT sessions, with additional ECT session as needed. Participants were mostly female (61.7%) with a mean age of 70.5 ± 7.2 years. “STABLE + PHARM” patients received 4.5 ± 2.5 ECT sessions during Phase 2. “STABLE + PHARM” group had 7 point advantage (3.5–10.4, 95% CI) for Physical Component Score of SF-36 (P < 0.0001), and 8.2 point advantage (4.2–12.2, 95% CI) for Mental Component Score (P < 0.0001). Additional ECT resulted in overall net health benefit. Consideration should be given to administration of additional ECT to prevent relapse during the continuation phase of treatment of MDD. Clinical Trials.gov NCT01028508 [ABSTRACT FROM AUTHOR]