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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 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]

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]

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]

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: 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]

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]

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]

Background: Depressive symptoms in pregnant women, which are common and debilitating, are often co-morbid with other mental disorders (e.g. anxiety and personality disorders), and related to low socioeconomic status (SES). This situation may hamper treatment outcome, which has often been neglected in previous studies on the treatment of depression during pregnancy. We developed a new group-based multicomponent treatment (GMT) comprising cognitive behavioral therapy, psycho-education and body-oriented therapy and compared the effect on depressive symptoms with individual counseling (treatment as usual, TAU) in a heterogeneous group of pregnant women with co-morbid mental disorders and/or low SES.Methods: An outpatient sample from a university hospital of 158 pregnant women who met DSM-IV criteria for mental disorders were included and 99 participants were randomized to GMT or TAU from January 2010 until January 2013. The Edinburgh Depression Scale (EDS) was used at baseline, every 5 weeks during pregnancy and as the primary outcome measure of depressive symptoms at 6 weeks postpartum. Secondary outcome measures included the clinician-reported Hamilton Depression Rating Scale (HDRS), obstetric outcomes and a 'Patient Satisfaction' questionnaire.Results: 155 participants were included the intention-to-treat (ITT)-analysis. GMT was not superior above TAU according to estimated EDS (β = 0.13, CI = - 0.46-0.71, p = 0.67) and HDRS scores (β = - 0.39, CI = - 0.82-0.05, p = 0.08) at 6 weeks postpartum. There were no differences in secondary outcomes between the GMT and TAU, nor between the randomized condition and patient-preference condition.Limitations: The ability to detect an effect of GMT may have been limited by sample size, missing data and the ceiling effect of TAU.Conclusions: GMT is an acceptable treatment for a heterogeneous group of pregnant women with depressive symptoms and co-morbid mental disorders and/or low SES, but not superior to TAU. Further research should focus on understanding and treating co-morbid disorders and psychosocial problems during pregnancy.Clinical Trials Registration: Dutch trial registry, www.trialregister.nl under reference number: NTR3015. [ABSTRACT FROM AUTHOR]

Background: Depression has become a critical global health problem, affecting millions of people. Cost-effective nonpharmacological treatment in community settings has been proposed to complement medical treatment. Short-term clay art therapy (CAT) is an alternative treatment that promotes the enhancement of various aspects of mental health for depressed individuals.Methods: One-hundred and six adults with depression were randomized into a CAT group or visual art (VA) control group for six 2.5-h weekly sessions. Intervention effects were measured using the Beck Depression Inventory, 12-Item General Health Questionnaire (Chinese version), Body-Mind-Spirit Well-Being Inventory, and 20-Item Toronto Alexithymia Scale (Chinese version) at baseline, immediately postintervention (T1), and 3-weeks postintervention (T2).Result: Multivariate analysis of covariance results indicated a more significant time × group effect for CAT than for VA on depressive signs, general health, and body-mind-spirit well-being (all p<0.05). Significant within-groups changes were observed in these three aspects after treatment and at T2 (all p<0.001) and in alexithymia at T2 (p<0.01) in the CAT group, but the change was nonsignificant in the VA group at T1 and T2.Limitations: The homogeneity of the participants affected the generalizability of the study findings. The short-term postintervention follow-up (3 weeks) presented difficulties in demonstrating the long-term effects of CAT.Conclusions: CAT can aid emotion regulation and benefit various aspects of mental health in adults. The short duration of the intervention suggests additional application value in treating depression. Further investigation is warranted regarding the potential effect of CAT on alleviating physical symptoms and improving social function. [ABSTRACT FROM AUTHOR]

This study evaluated the efficacy of an interactive media-based, computer-delivered depression treatment program (imbPST) compared to a no-treatment control condition (NTC) in a parallel-group, randomized, controlled trial conducted in an outpatient psychiatric research clinic. 45 adult participants with major depressive disorder or dysthymia were randomized to receive either 6 weekly sessions of imbPST or no treatment (No Treatment Control; NTC). The primary outcome measure was the Beck Depression Inventory II (BDI-II). There was a significant Group x Time interaction effect [F (1.73, 43)= 58.78; p<.001; η2=.58, Cohens d=1.94], such that the patients receiving imbPST had a significantly greater reduction in depressive symptoms compared to the patients in the NTC condition. Participants in the imbPST group improved their depression symptoms significantly from moderate (BDI-II=21.9±4.20) to mild levels of depression (BDI-II=17.9±4.0) after receiving 3 weekly sessions of imbPST (p<0.001), and progressed to still milder levels of depression after six weekly sessions (BDI-II=14.5±3.7, p<0.001). NTC participants showed no significant reduction in BDI-II scores (BDI-II=21.8±4.2 pre, BDI-II=21.5±5.2 post, N.S.). Additionally, 40% of the imbPST group showed a clinically significant and reliable change in depression levels while none of the NTC group met this criterion. imbPST participants rated the program highly usable on the system usability scale (SUS) after the first session (SUS Session 1=74.6±7.2) and usability scores increased significantly by the last session (SUS Session 6=85.4±5.6). We conclude that imbPST is an effective, engaging, and easily used depression treatment program that warrants further evaluation with heterogeneous depressed populations in a stand-alone, self-administered fashion. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is associated with hypoactivation of the dorsolateral prefrontal cortex, a brain region involved in emotion regulation and basic cognitive control processes. Recent studies have indicated that computerized interventions designed to activate this region may reduce depressive and ruminative symptoms. In this double-blind randomized controlled trial, we tested whether one such program, called Cognitive Control Training (CCT), enhanced treatment outcomes when used in adjunct to brief behavior therapy for MDD.Methods: Thirty-four adults with MDD were randomly assigned to complete four sessions of either computerized CCT or a control task, concurrently with four sessions of Brief Behavioral Activation Therapy for Depression (BATD). Post-treatment and one-month follow-up assessments were conducted, with self-reported depressive symptoms as the primary outcome and clinician-rated depressive symptoms and self-reported rumination as secondary outcomes.Results: In both intent-to-treat and completer analyses, depressive symptoms and rumination decreased significantly over the course of treatment in both treatment conditions. There were no significant differences in treatment outcome depending on the augmentation condition.Limitations: The sample size was small, hindering secondary analyses and identification of potential predictors or moderators of treatment effect.Conclusions: Results demonstrate substantial clinical benefit following four sessions of BATD; however, adjunctive CCT did not enhance outcomes. This study and other recent research suggest that the effects of CCT may not be as robust as previously indicated, highlighting the need for continued investigation of the conditions under which CCT may be effective. [ABSTRACT FROM AUTHOR]

Due to the limited cognitive and communicative abilities of adults with intellectual disabilities (ID), current treatment options for depression are often limited to lifestyle changes and pharmacological treatment. Bright light therapy (BLT) is an effective intervention for both seasonal and non-seasonal depression in the general population. BLT is an inexpensive, easy to carry out intervention with minimal side effects. However, knowledge on its anti-depressant effect in adults with ID is lacking. Obstacles in realizing a controlled intervention study in this particular study population may have contributed to this lack. To study the effect of BLT on depression in this population, it is necessary to successfully execute a multicenter randomized controlled trial (RCT). Therefore, the study protocol and the management of anticipated obstacles regarding this trial are presented. [ABSTRACT FROM AUTHOR]

Background: Ketamine is a glutamate N-methyl-d-aspartate receptor antagonist capable of exerting antidepressive effects in single or repeated intravenous infusions. The objective of this study was to investigate the safety and the efficacy of oral ketamine vs. diclofenac monotherapy in reducing symptoms of mild to moderate depression among patients with chronic pain.Methods: This study is a 6-week, randomized, double-blind, controlled, parallel-group trial with two intervention arms (ketamine, fixed daily dosage of 150mg vs. diclofenac, fixed daily dosage of 150mg). Twenty participants in each arm completed the trial program all of whom had two post-baseline measurements at week 3 and week 6. Reduction in depression symptoms was assessed using the Hamilton Depression Rating Scale (HDRS) and the hospital anxiety and depression subscale for depression (HADSDepression) scores at baseline and week 3 and week 6 post-intervention.Results: Significantly lower HDRS scores were observed in the ketamine treatment group as early as 6 weeks post-intervention (P=0.008). By comparison, mean (±standard deviation) HADS depression subscale scores were significantly lower for individuals receiving ketamine compared to diclofenac for both post-baseline measures at week 3 (6.95±1.47 vs. 8.40±1.6, P=0.005) and week 6 (6.20±1.15 vs. 7.35±1.18, p=0.003).Limitations: The limitations of the present study were its small sample size and the short-term follow-up period.Conclusions: Oral ketamine appears to be a safe and effective option in improving depressive symptoms of patients with chronic pain with mild-to-moderate depression. [ABSTRACT FROM AUTHOR]

Background: In epidemiological studies, statins appear to benefit mood, and there are now some randomized controlled trials examining the efficacy of statins. However, the role of statins in depression remains uncertain. Thus the aim of this paper was to assess the effect of statins on depressive symptoms by performing a meta-analysis of all double-blind, randomized, placebo controlled clinical trials (RCT) conducted in subjects with depression.Methods: A systematic search was executed using PubMed and ClinicalTrials.gov in November 30th, 2015 for all double-blind, RCT of statins versus placebo in persons with depressive symptoms. Sixty-seven potential articles were identified through search of electronic databases, of those three met inclusion criteria and were included in the meta-analysis. The outcome measure was change in Hamilton Depression Rating Scale (HDRS) scores associated with statin use. A meta-analysis was conducted and standardized mean differences (SMDs) with 95% confidence intervals (CIs) were calculated. GRADE was used to assess study quality.Results: The three articles included provided data on 165 participants with moderate to severe depression. Of these, 82 were randomized to statins as an adjuvant therapy to antidepressant treatment (i.e., citalopram or fluoxetine) and 83 to the placebo arm. All studies were double-blind RCTs, with a follow-up of 6-12 weeks. The statin agents evaluated were lovastatin, atorvastatin, and simvastatin. When compared to placebo, statins, as add-on to treatment as usual, largely improved depressive symptoms as assessed by the HDRS (SMD=-0.73, 95% IC -1.04 to -0.42, p<0.001, 3 between-group comparisons, n=165). No serious adverse effects were reported.Conclusions: Our results suggest that adjunctive treatment with statins could be useful for the treatment of depressive symptoms. Additional double-blind, randomised, placebo-controlled trials are necessary to settle the matter. [ABSTRACT FROM AUTHOR]

Background: The efficacy of cognitive behavioral therapy (CBT) for the treatment of depressive disorders has been demonstrated in many randomized controlled trials (RCTs). This study investigated whether for CBT similar effects can be expected under routine care conditions when the patients are comparable to those examined in RCTs.Method: N=574 CBT patients from an outpatient clinic were stepwise matched to the patients undergoing CBT in the National Institute of Mental Health Treatment of Depression Collaborative Research Program (TDCRP). First, the exclusion criteria of the RCT were applied to the naturalistic sample of the outpatient clinic. Second, propensity score matching (PSM) was used to adjust the remaining naturalistic sample on the basis of baseline covariate distributions. Matched samples were then compared regarding treatment effects using effect sizes, average treatment effect on the treated (ATT) and recovery rates.Results: CBT in the adjusted naturalistic subsample was as effective as in the RCT. However, treatments lasted significantly longer under routine care conditions.Limitations: The samples included only a limited amount of common predictor variables and stemmed from different countries. There might be additional covariates, which could potentially further improve the matching between the samples.Conclusions: CBT for depression in clinical practice might be equally effective as manual-based treatments in RCTs when they are applied to comparable patients. The fact that similar effects under routine conditions were reached with more sessions, however, points to the potential to optimize treatments in clinical practice with respect to their efficiency. [ABSTRACT FROM AUTHOR]

Objective: Multiple chemical sensitivity (MCS) is a medically unexplained condition characterized by symptoms from multiple organ systems following the perception of common odorants. The condition can cause severe functional impairment for afflicted individuals. The aim of this study was to assess the effects of mindfulness-based cognitive therapy (MBCT) for individuals with MCS.Methods: The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and Sensitivity Inventory (QEESI), which measures the following aspects ofMcs: impact of MCS on daily life, symptoms, and reactions following chemical exposures. Secondary outcome measures included the Brief Illness Perception Questionnaire (BIPQ) and the anxiety and depression subscales of the symptom checklist 92 (SCL-92). Participants were assessed at baseline and post treatment, and at follow-up periods of 6- and 12-months.Results: We found no effect of MBCT on the primary outcome, nor did we find an effect on levels of depression or anxiety. We did, however, find positive changes in illness perceptions, which were sustained at 12-month follow-up. Dropout rates were low, suggesting MBCT was well received and regarded as an acceptable intervention by individuals with MCS.Conclusions: Overall, these results suggest that MBCT does not change overall illness status in individuals with MCS, but that MBCT positively changes emotional and cognitive representations. Possible explanations for these results are discussed. [ABSTRACT FROM AUTHOR]

Background: Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. Our aim was to investigate whether the addition of MBCT to mADM is a more effective prevention strategy than mADM alone.Methods: This study is one of two multicenter randomised trials comparing the combination of MBCT and mADM to either intervention on its own. In the current trial, recurrently depressed patients in remission who had been using mADM for 6 months or longer (n=68), were randomly allocated to either MBCT+mADM (n=33) or mADM alone (n=35). Primary outcome was depressive relapse/recurrence within 15 months. Key secondary outcomes were time to relapse/recurrence and depression severity. Analyses were based on intention-to-treat.Results: There were no significant differences between the groups on any of the outcome measures.Limitations: The current study included patients who had recovered from depression with mADM and who preferred the certainty of continuing medication to the possibility of participating in MBCT. Lower expectations of mindfulness in the current trial, compared with the parallel trial, may have caused selection bias. In addition, recruitment was hampered by the increasing availability of MBCT in the Netherlands, and even about a quarter of participants included in the trial who were allocated to the control group chose to get MBCT elsewhere.Conclusions: For this selection of recurrently depressed patients in remission and using mADM for 6 months or longer, MBCT did not further reduce their risk for relapse/recurrence or their (residual) depressive symptoms. [ABSTRACT FROM AUTHOR]

Objective: Body dysmorphic disorder (BDD) typically starts in adolescence, but evidence-based treatments are yet to be developed and formally evaluated in this age group. We designed an age-appropriate cognitive-behavioral therapy (CBT) protocol for adolescents with BDD and evaluated its acceptability and efficacy in a pilot randomized controlled trial.Method: Thirty adolescents aged 12 to 18 years (mean = 16.0, SD = 1.7) with a primary diagnosis of BDD, together with their families, were randomly assigned to 14 sessions of CBT delivered over 4 months or a control condition of equivalent duration, consisting of written psycho-education materials and weekly telephone monitoring. Blinded evaluators assessed participants at baseline, midtreatment, posttreatment, and at 2-month follow-up. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, Adolescent Version (mean baseline score = 37.13, SD = 4.98, range = 24-43).Results: The CBT group showed a significantly greater improvement than the control group, both at posttreatment (time × group interaction coefficient [95% CI] = -11.26 [-17.22 to -5.31]; p = .000) and at 2-month follow-up (time × group interaction coefficient [95% CI] = -9.62 [-15.74 to -3.51]; p = .002). Six participants (40%) in the CBT group and 1 participant (6.7%) in the control condition were classified as responders at both time points (χ(2) = 4.658, p = .031). Improvements were also seen on secondary measures, including insight, depression, and quality of life at posttreatment. Both patients and their families deemed the treatment as highly acceptable.Conclusion: Developmentally tailored CBT is a promising intervention for young people with BDD, although there is significant room for improvement. Further clinical trials incorporating lessons learned in this pilot study and comparing CBT and pharmacological therapies, as well as their combination, are warranted.Clinical Trial Registration Information: Cognitive-Behaviour Therapy for Adolescents With Body Dysmorphic Disorder; http://www.isrctn.com/; ISRCTN67699666. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a multifactorial fall prevention program was more effective than usual geriatric care in preventing falls and reducing fear of falling in frail community-dwelling older fallers, with and without cognitive impairment, and in alleviating subjective caregiver burden in caregivers. Design, Setting, and Participants: A randomized, 2 parallel-group, single-blind, multicenter trial conducted in 36 pairs of frail fallers, who were referred to a geriatric outpatient clinic after at least 1 fall in the past 6 months, and their informal caregivers. Intervention: Groups of 5 pairs of patients and caregivers received 10 twice-weekly, 2-hour sessions with physical and psychological components and a booster session. Measurements: The primary outcome was the fall rate during a 6-month follow-up. Additionally, we measured fear of falling and subjective caregiver burden. Data on the secondary outcome measures were collected at baseline, directly after, and at 3 and 6 months after the last session of the intervention. Results: Directly after the intervention and at the long-term evaluation, the rate of falls in the intervention group was higher than in the control group, although these differences were not statistically significant (RR = 7.97, P = .07 and RR = 2.12, P = .25, respectively). Fear of falling was higher in the intervention group, and subjective caregiver burden did not differ between groups. Conclusion: Although we meticulously developed this pairwise multifactorial fall prevention program, it was not effective in reducing the fall rate or fear of falling and was not feasible for caregivers, as compared with regular geriatric care. Future research initiatives should be aimed at how to implement the evidence-based principles of geriatric fall prevention for all frail fallers rather than developing more complex interventions for the frailest. [Copyright &y& Elsevier]