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Introduction: and objective: Tremor is a disabling symptom of PD that usually responds poorly to available standard pharmacological agents. This study aimed to assess the effect of Zonisamide 25 mg on tremor in tremor-dominant PD patients as compared to placebo.Methods: This was a randomized, placebo-controlled, double-blind study. Parkinson's disease patients were allocated either to the intervention group (standard treatment along with Zonisamide 25 mg add-on) or the placebo group (standard treatment along with placebo). Baseline Unified Parkinson's Disease Rating Scale (UPDRS) and Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, as well as accelerometric tremor analysis were done and follow-up assessments of the same were done after 12 weeks of intervention. Percentage change from baseline in the UPDRS tremor score was the primary outcome whereas percentage change from baseline of total UPDRS score, UPDRS rigidity and bradykinesia scores, TETRAS score, and accelerometric tremor analysis values were the secondary outcomes.Results: There was no significant difference in the percentage change from baseline UPDRS tremor scores between the two groups (placebo: 8.33 [-19.89-23.86] vs drug: 26.14 [-35.58 to -16.07], p-value: 0.164, CI: 0.157-0.171). Best-case analysis for missing values showed a significant improvement in the drug group, compared to the placebo group (p-value: < 0.001, CI: <0.001 - <0.001).Conclusion: Zonisamide at a dose of 25 mg per day did not improve tremor in tremor-dominant PD patients, however, a positive trend was seen as compared to Placebo in the UPDRS tremor score. Larger studies are required to confirm this finding. [ABSTRACT FROM AUTHOR]

Recovery-oriented practice has been advocated in mental health services in Hong Kong since 2009. Well-being has become an important area of focus for mental health services. Positive Psychotherapy for Psychosis (PPP) is a well-being-focused intervention for use in psychosis, with preliminary evidence from a randomized controlled trial in the United Kingdom of impact on well-being and symptomatology. The aim of this study was to test the effectiveness of PPP on the well-being of people with psychosis in Hong Kong. The study was a randomized controlled trial with two-arm parallel groups. Both groups received treatments as usual, and in addition the intervention group received a 13-session intervention based on a Cantonese Chinese translation of the PPP manual. Intention-to-treat analysis was used. The trial was registered (ANZCTR: ACTRN12620000464965). A total of 154 participants (78 intervention, 76 control) were recruited. As compared to control group, intervention group participants showed significant changes over time on the primary outcome of well-being assessed using the Chinese Short Warwick-Edinburgh Mental Well-being Scale (p = 0.001) and on secondary outcomes of hope (Agency subscale: p = 0.029) and self-efficacy (p = 0.001). Positive Psychotherapy for Psychosis was found to be an effective treatment in improving the well-being and other mental health outcomes for people with psychosis. It can be recommended for use in mental health services to promote recovery. [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: 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: Few treatments are available for patients with idiopathic hypersomnia (IH). Modafinil, an established treatment for narcolepsy, was tested for efficacy and safety in Japanese patients with IH without long sleep time.Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted at 20 institutions in Japan. Patients who met the diagnostic criteria of IH in the International Classification of Sleep Disorders (second edition) were included. The study comprised a ≥17-day observation period and a 3-week treatment period during which modafinil (200 mg) or placebo was administered orally once daily (in the morning). The primary efficacy endpoint was change in mean sleep latency on the Maintenance of Wakefulness Test (MWT). Adverse events (AEs) were also recorded to evaluate safety.Results: In total, 123 patients were screened and 71 were randomized to receive modafinil (N = 34) or placebo (N = 37). Patients treated with modafinil experienced a significantly prolonged mean sleep latency on the MWT at the end of the study compared with placebo (5.02 min, 95% confidence interval: 3.26-6.77 min; p < 0.001). AEs occurred in 58.8% (20/34) and 27.0% (10/37) of patients in the modafinil and placebo groups, respectively. Frequent AEs in the modafinil group were headache (n = 6), dry mouth (n = 3), and nausea (n = 3); no clinically significant AEs occurred.Conclusion: Modafinil was shown to be an effective and safe treatment for excessive daytime sleepiness in patients with IH without long sleep time.Clinical Trial Registration: JapicCTI; 142539. [ABSTRACT FROM AUTHOR]

Background Context: Microendoscopic spinal surgery has demonstrated efficacy and is increasingly utilized as a minimally invasive approach to neural decompression, but there is a theoretical concern that bleeding and postoperative epidural hematoma (PEH) may occur with increased frequency in a contained small surgical field. Hemostatic agents, such as topical gelatin-thrombin matrix sealant (TGTMS), are routinely used in spine surgery procedures, yet there has been no data on whether PEH is suppressed by these agents when administered in microendoscopic spine surgery.Purpose: The purpose of this study was to investigate the effect of TGTMS on bleeding and PEH formation in lumbar micoroendoscopic surgery.Study Design: This is a randomized controlled trial (RCT) with additional prospective observational cohort.Patient Sample: Patients were registered from July 2017 to September 2018 and a hundred and three patients undergoing microendoscopic laminectomy for lumbar spinal stenosis at a single institution were enrolled in this study.Outcome Measures: The primary outcome was the drainage volume within 48 hours after surgery. Secondary outcomes were the numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI).Methods: In the RCT, 41 cases that received TGTMS (F group) were compared with 41 control group cases (C group) that did not receive TGTMS at the end of the procedure. Drainage volume, NRS2, NRS7, and HAR on MRI were evaluated. Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis. I group was compared with C group in the drainage volume and NRS of leg pain as a prospective observational study.Results: The RCT demonstrated no statistically significant difference in drainage volume between those receiving TGTMS (117.0±71.7; mean±standard deviation) and controls (125.0±127.0; p=.345). The NRS2 and NRS7 was 3.5±2.6 and 2.8±2.5 in the F group, respectively, and 3.1±2.6 and 2.1±2.3 in the C group, respectively. The HAR on MRI was 0.19±0.19 in the F group and 0.17±0.13 in the C group. There was no significant difference in postoperative leg pain and HAR (p=.644 for NRS2, p=.129 for NRS7, and p=.705 for HAR). In the secondary observational cohort, the drainage volume in the I group was 118.3±151.4, and NRS2 and NRS7 was 3.5±2.0 and 2.6±2.6, respectively. There were no statistically significant differences in drainage volume (p=.386) or postoperative NRS of leg pain between these two groups (p=.981 and .477 for NRS2 and NRS7, respectively).Conclusions: The prophylactic use of TGTMS in patients undergoing microendoscopic laminotomy for lumbar spinal stenosis did not demonstrate any difference in postoperative bleeding or PEH. Nonetheless, for patients that had active bleeding that required the use of TGTMS, there was no evidence of difference in postoperative clinical outcomes relative to controls. [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]

Objectives: To examine the effects of an empowerment-based intervention on health-related knowledge and resilience among patients after coronary artery stent implantation.Methods: This was a randomized controlled trial with a 4-week-long intervention. Participants were randomly allocated to an empowerment-based intervention group (n = 42) or control group (n = 43). Knowledge on CHD and resilience were evaluated and compared between groups.Results: Compared with the control group, patients in the intervention group showed higher score changes for CHD total knowledge (U = 196.500; P ＜ 0.001) and its 5 dimensions including CHD definition (U = 657.500; P = 0.022), manifestation (U = 245.000; P ＜ 0.001), examination (U = 639.000; P = 0.015), treatment (U = 475.000; P ＜ 0.001), and medication (U = 465.000; P ＜ 0.001), and higher level of resilience (t = 3.235; P = 0.002).Conclusion: The empowerment-based intervention was effective in enhancing the knowledge on CHD and improving resilience for patients with coronary artery stent implantation.Practice Implications: The structured empowerment-based intervention provides a basis for facilitating the use of this intervention in patients with coronary heart disease. [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: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.Objectives: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.Methods: A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.Results: The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).Conclusions: At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533). [ABSTRACT FROM AUTHOR]

Hangovers are associated with negative economic consequences due to decreased job performance or frequent visits to physicians. Thus, a new strategy for the alleviation of hangover-related symptoms is needed to avoid this detriment to society. The purpose of this nationwide randomized, double-blind, placebo-controlled physicians' trial was to evaluate the efficacy of loxoprofen sodium for the alleviation of fatigue, headache, and nausea after hangover. A total of 229 participants were randomized to receive loxoprofen sodium (60 mg once orally) or placebo. The study was closed when the first 150 participants (n = 74 in the loxoprofen vs. n = 76 in the placebo groups) experienced hangovers. The primary endpoint was set as the difference in severity of general fatigue before and 3 h after taking the test drugs and was evaluated using a visual analogue scale. Secondary endpoints included difference in severity of headache, nausea, and incidence of adverse events. The study participants were 34 (interquartile range; 30-39) years old, 92.0% were men, and both groups were comparable for baseline characteristics. The alleviation of general fatigue did not differ statistically between the loxoprofen and placebo groups (24 [14-49] vs. 19 [9-35], p = 0.07). However, the alleviation of headache was statistically greater in the loxoprofen group (25 [10-50] vs. 10 [2-30], adjusted difference 14, 95% confidence interval 8-21, p < 0.001), whereas, there was no difference in nausea (7 [0-27] vs. 10 [0-24], p = 0.68). The incidence of adverse symptoms such as epigastric discomfort was also comparable between groups (2.7% vs. 3.9%, p = 0.25). Loxoprofen sodium was effective for relieving headaches after hangovers but did not alleviate general fatigue or nausea. [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: Internet-based intervention could help drug users recover from drug dependence. This study evaluated the effectiveness of a newly developed web-based relapse prevention program (e-SMARPP) for people with a drug problem, including the use of methamphetamine, in Japan.Methods: The study was a pilot randomized controlled trial comprised of 48 psychiatric outpatients diagnosed with drug use disorder. The participants were randomly assigned to an eight-week, six-session web-based relapse prevention program (an intervention group) or only web-based self-monitoring (a control group). The primary outcome was the duration of abstinence from a primary drug during the intervention and relapse risk. Secondary outcomes included motivation to change, self-efficacy, and money spent on drugs. The outcomes, except for the duration of abstinence during the intervention, were assessed at baseline, 2-, 5-, and 8-months. Program completion rate was also assessed.Results: No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes. The effect size of the duration of abstinence during the intervention was d = 0.42, which was comparable to previous studies. In the intervention group, about 26% did not complete the entire intervention.Conclusions: e-SMARPP failed to demonstrate efficacy, however, is potentially helpful for enhancing abstinence. The low attrition rate may suggest the acceptance and feasibility of the program. Further improvement of the program and evaluation in a full-scale trial are needed. [ABSTRACT FROM AUTHOR]

Background: The pain of a burn mainly results from the inflammatory cascade that is induced by the injured tissue, and is classified as background, breakthrough, procedural and postoperative pain. High doses of opioids are usually needed to treat background pain, so its management includes a combination of types of analgesia to reduce the side effects. Lidocaine given intravenously has been shown in two small, uncontrolled studies to have an appreciable effect on pain after burns.Objectives: In this prospective double-blind controlled trial we aimed to examine and quantify the opioid-sparing effect of a continuous infusion of lidocaine for the treatment of background pain during the early period after a burn.Methods: Adult patients injured with burns of >10 total body surface area burned (TBSA%) and treated with a morphine based patient-controlled analgesia device (PCA) were randomised to have either lidocaine infusion starting with a bolus dose (1 mg lidocaine/kg) followed by continuous infusion (180 mg lidocaine/hour) or a placebo infusion, for seven consecutive days. Total daily consumption of opioids (mg) and amount of pain (visual analogue score, VAS) were recorded.Results: We included 19 patients, 10 of whom were given a lidocaine infusion. There were no differences between groups in VAS, TBSA%, time of enrolment to the study since the initial burn, or duration of hospital stay. The opioid consumption in the lidocaine group declined by roughly 25% during the period of the study.Conclusion: An intravenous infusion of lidocaine was safe and had an opioid-sparing effect when treating background pain in burns. [ABSTRACT FROM AUTHOR]

Context: Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.Objectives: We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.Methods: A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.Results: Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002).Conclusion: Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine. [ABSTRACT FROM AUTHOR]

Introduction: This study compared changes in sleep disturbance over time across brief cognitive behavioral therapy for suicide prevention and treatment as usual and examined the mechanisms that link sleep disturbance with several suicide risk factors.Method: Active duty U.S. Army soldiers (N = 152) completed a randomized controlled trial to test the efficacy of brief cognitive behavioral therapy (n = 76) or treatment as usual (n = 76). Six assessments of insomnia symptoms, hopelessness, coping, and suicide beliefs were tracked over 24 months.Results: Brief cognitive behavioral therapy patients reported a significant decrease in sleep disturbance symptoms over time while treatment as usual patients did not. These improvements were initially observed during treatment and carried over through 12-months. Changes in sleep disturbance predicted changes in suicide risk. Longitudinal growth modeling was used to assess potential mechanisms of this effect. Results suggested that changes in cognitive flexibility, as defined by measures of hopelessness and suicide beliefs, predicted change in sleep disturbance symptoms. These relationships did not differ across treatment groups.Limitations: The participants were active duty military personnel. Therefore, the results may not generalize to other patient populations. A greater number of assessment periods in closer proximity as well as additional measures of constructs of interest would have improved the internal validity of this study.Conclusions: Brief cognitive behavioral therapy significantly reduces sleep disturbance and suicide risk. Changes in cognitive flexibility, in part, explain change in sleep disturbance across both treatments. [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]

Objective: Bibliotherapy refers to psychological self-help interventions that utilize treatment books to improve psychological well-being. Research supports bibliotherapy as an efficacious intervention for a variety of mental health problems. Yet, few studies have investigated bibliotherapy in psychosocial oncology. The objective of this randomized controlled trial was to examine the efficacy of the NuCare intervention, delivered as a self-directed workbook, for enhancing empowerment, coping, and quality of life and reducing distress in patients with cancer.Methods: Eighty-nine adult patients with cancer were randomized to receive the workbook for 6 weeks or the control condition, usual care. Participants completed questionnaires at baseline, 6 weeks post-baseline, and 10 weeks post-baseline.Results: The increase of empowerment (main outcome) and quality of life and the decrease of distress in the NuCare group from pre-intervention to follow-up assessment differed significantly from the respective difference scores in the control group.Conclusions: The self-administered NuCare workbook is a potentially cost-effective, minimal intervention addressing psychosocial needs of patients with cancer.Practice Implications: Evidence-based bibliotherapy can empower patients and has the promise of reducing the burden on the healthcare system while enhancing the immediacy of psychosocial support. [ABSTRACT FROM AUTHOR]

Background: Service providers including doctors, nurses, and other healthcare professionals play an essential role in methadone maintenance treatment (MMT). This study evaluated the impact of an intervention targeting MMT providers on their clients' treatment retention.Methods: This study was conducted in 68 MMT clinics in five provinces of China with 36 clients randomly selected from each clinic. The clinics were randomized to intervention or control condition. The MMT CARE intervention started with group sessions to enhance providers' communication skills. The trained providers were encouraged to conduct individual sessions with clients to promote treatment engagement. The outcomes, which include client retention (main outcome) and their reception of provider-delivered individual sessions (process outcome), were measured over a 24-month period.Results: Significantly fewer intervention clients dropped out from MMT than control clients during the study period (31% vs. 41%; p < 0.0001). Dropout hazard was significantly lower in the intervention condition compared to the control condition (HR = 0.71, 95% CI: 0.57, 0.89). More intervention clients had individual sessions than control clients (93% vs. 70%; p < 0.0001). Having individual sessions was associated with a significantly lower dropout hazard (HR = 0.30, 95% CI: 0.23, 0.40). The intervention clients had a significantly lower dropout hazard than the control clients if they started the individual sessions during the first six months (HR = 0.68, 95% CI: 0.51, 0.90).Conclusions: The MMT CARE intervention focusing on provider capacity building has demonstrated efficacy in reducing clients' treatment dropout. This study sheds light on MMT service improvement in China and other global community-based harm reduction programs. [ABSTRACT FROM AUTHOR]

Study Objective: To analyze the effect of enteral nutrition compared with parenteral nutrition in critically ill patients.Design: Systematic review and meta-analysis of randomized controlled trials.Setting: Intensive care unit.Patients: 23 trials containing 6478 patients met our inclusion criteria.Intervention: A systematical literature search was conducted to identify eligible trials in electronic databases including PubMed, Embase, Scopus, EBSCO and Cochrane Library. The primary outcome was mortality, the secondary outcomes were gastrointestinal complications, bloodstream infections, organ failures, length of stay in ICU and hospital. We performed a predefined subgroup analyses to explore the treatment effect by mean age, publication date and disease types.Main Results: The result showed no significant effect on overall mortality rate (OR 0.98, 95%CI 0.81 to 1.18, P = 0.83, I2 = 19%) and organ failure rate (OR 0.87, 95%CI 0.75 to 1.01, P = 0.06, I2 = 16%). The use of EN had more beneficial effects with fewer bloodstream infections when compared to PN (OR 0.59, 95%CI 0.43 to 0.82, P = 0.001, I2 = 27%) and this was more noteworthy in the subgroup analysis for critical surgical patients (OR 0.36, 95%CI 0.22 to 0.59, P < 0.0001, I2 = 0%). EN was associated with reduction in hospital LOS (MD -0.90, 95%CI -1.63 to -0.17, P = 0.21, I2 = 0%) but had an increase incidence of gastrointestinal complications (OR 2.00, 95%CI 1.76 to 2.27, P < 0.00001, I2 = 0%).Conclusion: For critically ill patients, the two routes of nutrition support had no different effect on mortality rate. The use of EN could decrease the incidence of bloodstream infections and reduce hospital LOS but was associated with increased risk of gastrointestinal complications. [ABSTRACT FROM AUTHOR]

Objectives: Cardiac rehabilitation (CR) is an effective treatment for cardiovascular disease, yet many referred patients do not participate. Motivational interviewing could be beneficial in this context, but efficacy with prospective CR patients has not been examined. This study investigated the impact of motivational interviewing on intention to participate in CR.Methods: Individuals recovering from acute coronary syndrome (n = 96) were randomized to motivational interviewing or usual care, following CR referral but before CR enrollment. The primary outcome was intention to attend CR. Secondary outcomes included CR beliefs, barriers, self-efficacy, illness perception, social support, intervention acceptability, and CR participation.Results: Compared to those in usual care, patients who received the motivational intervention reported higher intention to attend CR (p = .001), viewed CR as more necessary (p = .036), had fewer concerns about exercise (p = .011), and attended more exercise sessions (p = .008). There was an indirect effect of the intervention on CR enrollment (b = 0.45, 95% CI 0.04-1.18) and CR adherence (b = 2.59, 95% CI 0.95-5.03) via higher levels of intention. Overall, patients reported high intention to attend CR (M = 6.20/7.00, SD = 1.67), most (85%) enrolled, and they attended an average of 65% of scheduled CR sessions.Conclusion: A single collaborative conversation about CR can increase both intention to attend CR and actual program adherence.Practice Implications: The findings will inform future efforts to optimize behavioral interventions to enhance CR participation. [ABSTRACT FROM AUTHOR]

Background Context: The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown.Purpose: The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control.Study Design/setting: This is a two-site, open-label randomized controlled trial.Patient Sample: Participants were 256 adults with chronic CGH.Outcome Measures: The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction.Methods: Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest.Results: A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome.Conclusions: There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control. [ABSTRACT FROM AUTHOR]

Background: Identifying the characteristics of individuals who are most likely to respond to a certain rehabilitation intervention is advantageous for the child, family, clinicians and the healthcare system.Aim: To investigate the individual characteristics of children with cerebral palsy or brain injury who responded best to the Cognitive Orientation to daily Occupational Performance (CO-OP) Approach.Methods: Post hoc analyses were conducted on 30 participants who participated in CO-OP within a larger randomized controlled trial. Inclusion: cerebral palsy or brain injury; age 4-15 years; Manual Abilities Classification System (MACS) I-IV; goals related to hand function; sufficient cognitive, language and behavioral ability to undertake CO-OP. Outcome measures were the Canadian Occupational Performance Measure (COPM) and Goal Attainment Scale (GAS) collected immediately following the two week intervention period.Results: Following CO-OP, 67% (n = 20) of participants showed a statistically significant response on the COPM, and 73%(n = 22) on the GAS. Nine participants were classified as best responders. When compared to non-responders, best responders were more likely to be female (p = .025) and to have received a higher dose of CO-OP (p = .028). Neither age nor MACS were predictors of response.Conclusion: To be successful in CO-OP, children should meet the prerequisites of CO-OP, particularly the language and cognitive ability to set goals and communicate effectively with the therapist. In this small sample, children with comorbidities were less likely to achieve goals, females were more likely to respond and dose of therapy was important to success. [ABSTRACT FROM AUTHOR]

Background: Drug use is an established risk factor for HIV. Brief Interventions (BIs) targeting reductions in both drug use and HIV risk behaviors may help curtail these related epidemics. The present study evaluates the impact of BIs for drug use and HIV risk reduction on sexual HIV risk behaviors among a primarily marijuana-using sample during a 12-month post-intervention follow-up period.Methods: We conducted a randomized controlled trial of 780 adult patients in an Emergency Department (ED) with past 3-month drug use (primarily non-injecting). This study used a 3 × 2 factorial design (3 ED-based conditions: computer-delivered brief intervention [Computer BI], therapist-delivered, computer-guided BI [Therapist BI], or enhanced usual care (EUC-ED) for drug-using adults; 2 follow-up conditions at 3 months: booster or control). This analysis examines the outcomes of the BIs on sexual HIV risk behaviors at 3-, 6-, and 12-months.Results: Compared to the enhanced usual care control, the combined Therapist BI with booster resulted in significant reductions in scores on the sexual risk subscale of the HIV Risk Taking Behaviour Scale over 12-months, when controlling for baseline sexual risk, gender, and drug dependency status. The baseline interventions alone, booster alone, and Computer BI plus booster did not differ from the comparison group (EUC plus control).Conclusions: A therapist-delivered BI for drug use and HIV risk behaviors, combined with a follow-up therapist-delivered booster, shows promise for reducing sexual HIV risk behaviors among a primarily marijuana using, non-injecting sample. [ABSTRACT FROM AUTHOR]

Background: A lack of objective outcome measures and overreliance on subjective pain reports in early proof-of-concept studies contribute to the high attrition of potentially effective new analgesics. We studied the utility of neuroimaging in providing objective evidence of neural activity related to drug modulation or a placebo effect in a double-blind, randomized, placebo-controlled, three-way crossover trial.Methods: We chronically administered pregabalin or tramadol (first-line and second-line analgesics, respectively), recommended for neuropathic pain, in 16 post-traumatic neuropathic pain patients. We measured subjective pain reports, allodynia-evoked neural activity, and brain resting state functional connectivity from patients during the three sessions and resting state data at baseline from patients after washout of their current medication. All data were collected using a 3 T MRI scanner.Results: When compared with placebo only, pregabalin significantly suppressed allodynia-evoked neural activity in several nociceptive and pain-processing areas of the brain, despite the absence of behavioural analgesia. Furthermore, placebo significantly increased functional connectivity between the rostral anterior cingulate and the brainstem, a core component of the placebo neural network.Conclusions: Functional neuroimaging provided objective evidence of pharmacodynamic efficacy in a proof-of-concept study setting where subjective pain outcome measures are often unreliable. Additionally, we provide evidence confirming the neural mechanism underpinning placebo analgesia as identified in acute experimental imaging studies in patients during the placebo arm of a clinical trial. We explore how brain penetrant active drugs potentially interact with this mechanism.Clinical Trial Registration: NCT0061015. [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]

Context: Provision of home-based palliative care (PC) for seriously ill patients is important, yet few home-based PC services specifically or exclusively focus on end-stage heart failure (ESHF) patients.Objectives: This study aimed to examine the effect of a home-based palliative heart failure (HPHF) program on quality of life (QOL), symptoms burden, functional status, patient satisfaction, and caregiver burden among patients with ESHF.Methods: This study was a two-group randomized controlled trial undertaken in three hospitals. We recruited a total of 84 hospitalized ESHF patients who were referred to PC. They were randomized to the intervention or control group. The intervention group received a 12-week structured program with regular home visits/telephone calls provided by the nurse case managers. Data were collected at baseline (T1) and at four (T2) and 12 weeks (T3) after discharge.Results: A statistically significant between-group effect was found, with the HPHF group having significantly higher McGill QOL total score than the control group (P = 0.016) and there was significant group × time interaction effect (P = 0.032). There was no significant between-group effects detected for the measures of symptom distress or functional status at 12 weeks. The intervention group had higher satisfaction (P = 0.001) and lower caregiver burden (P = 0.024) than the control group at 12 weeks.Conclusion: The HPHF program is effective in enhancing the QOL of ESHF patients, satisfaction with care, and caregiver burden. The program has potential to reduce distress for some of the symptoms. [ABSTRACT FROM AUTHOR]

Background: In Parkinson's disease (PD) patients, fluctuations in symptoms commonly occur after many years of dopamine replacement therapy. The so-called wearing-off phenomenon exists of both motor and non-motor symptoms, such as rigidity and anxiety. Current treatment options are limited and an integrated approach is needed to address the complex interactions between motor and non-motor symptoms. Since wearing-off is eventually inevitable, treatment needs to focus on coping, acceptance and self-efficacy. We developed the body awareness training, named BEWARE, combining physical therapy with acceptance and commitment therapy to help PD patients deal better with wearing-off related anxiety (WRA).Methods: This was an investigator-blinded randomized controlled trial. Forty PD patients with WRA were randomly assigned to the BEWARE or to the treatment as usual (TAU) condition. Assessments were performed prior to and immediately after the treatment period, and at 3-months follow up. The primary outcome was self-efficacy, secondary outcomes focused on mobility, daily functioning, anxiety, depression and quality of life.Results: There was no significant improvement in self-efficacy in the BEWARE treatment condition when compared to TAU. However, standing balance and emotional wellbeing showed a significant improvement, and feelings of stigmatization showed a trend-significant decrease in the BEWARE condition.Conclusions: We consider the BEWARE training to be a promising therapeutic approach to address WRA. Improvement points from the participants included 1) less frequent but longer therapy sessions; 2) active involvement of caregivers; and 3) the development of a supportive workbook. The optimized treatment protocol needs further evaluation in a phase III RCT.Trial Registration: ClinicalTrials.gov identifier: NCT02054845. [ABSTRACT FROM AUTHOR]

Objective: Self-rated health (SRH) has been shown to be a stable predictor of illness and mortality. Improvement in SRH, even in the absence of change in objective health, predicts better health and reduced mortality. Severe health anxiety (SHA) is characterized by fear of illness and distorted health perception. The objective of the present study was to investigate if exposure-based cognitive behavior therapy (CBT) for SHA can lead to improvement in SRH and whether this improvement is mediated by reduced health anxiety.Methods: Data were collected from a randomized controlled trial where participants with SHA were allocated to 12weeks of exposure-based CBT (n=99) for SHA or to a no treatment control condition (n=33). The mediation analysis was based on SRH- and health anxiety data collected weekly during the treatment phase.Results: Linear mixed effects models analysis showed a significant interaction effect of group and time indicating superior improvements in SRH in exposure-based CBT compared to the control condition (Z=2.69, p=0.007). The controlled effect size was moderately large (d=0.64) and improvements were stable at 1-year follow-up. Reduced health anxiety was a significant mediator of improvement in SRH.Conclusions: 12weeks of exposure-based CBT for SHA can lead to significant improvements in SRH. Considering the previously established importance of SRH as a predictor for disease and mortality, exposure-based CBT for severe health anxiety may lead to improvements on several important health parameters, possibly even increasing the likelihood of longevity. [ABSTRACT FROM AUTHOR]

Rationale: Targeted temperature management (TTM) improves survival with good neurological outcome after out-of-hospital cardiac arrest (OHCA), but is delivered inconsistently and often with delay.Objective: To determine if prehospital cooling by paramedics leads to higher rates of 'successful TTM', defined as achieving a target temperature of 32-34°C within 6h of hospital arrival.Methods: Pragmatic RCT comparing prehospital cooling (surface ice packs, cold saline infusion, wristband reminders) initiated 5min after return of spontaneous circulation (ROSC) versus usual resuscitation and transport. The primary outcome was rate of 'successful TTM'; secondary outcomes were rates of applying TTM in hospital, survival with good neurological outcome, pulmonary edema in emergency department, and re-arrest during transport.Results: 585 patients were randomized to receive prehospital cooling (n=279) or control (n=306). Prehospital cooling did not increase rates of 'successful TTM' (30% vs 25%; RR, 1.17; 95% confidence interval [CI] 0.91-1.52; p=0.22), but increased rates of applying TTM in hospital (68% vs 56%; RR, 1.21; 95%CI 1.07-1.37; p=0.003). Survival with good neurological outcome (29% vs 26%; RR, 1.13, 95%CI 0.87-1.47; p=0.37) was similar. Prehospital cooling was not associated with re-arrest during transport (7.5% vs 8.2%; RR, 0.94; 95%CI 0.54-1.63; p=0.83) but was associated with decreased incidence of pulmonary edema in emergency department (12% vs 18%; RR, 0.66; 95%CI 0.44-0.99; p=0.04).Conclusions: Prehospital cooling initiated 5min after ROSC did not increase rates of achieving a target temperature of 32-34°C within 6h of hospital arrival but was safe and increased application of TTM in hospital. [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: Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs.Methods: A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters.Results: There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who received XR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences.Conclusions: Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events. [ABSTRACT FROM AUTHOR]

Objective: The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment.Participants and Design: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation.Results: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED. [ABSTRACT FROM AUTHOR]

Auditory hallucinations (AH) are a common and distressing experience and patients report distress reduction to be a priority. Relating Therapy adopts a symptom-specific and mechanism focused approach to the reduction of AH distress. We conducted this single-blind, pragmatic, parallel groups, superiority pilot RCT within a single mental health centre in the UK. Patients (18+years) with persistent and distressing AH, irrespective of diagnosis were randomly allocated to receive either Relating Therapy and Treatment-as-usual (RT) or Treatment as-usual alone (TAU). Assessment of outcome was completed pre-randomisation (T0), 16weeks post-randomisation (T1) and 36weeks post-randomisation (T2). The primary outcome was the 5-item Distress scale of the Psychotic Symptoms Rating Scale - Auditory Hallucinations (PSYRATS-AHRS) at T1. We randomly assigned 29 patients to receive RT (n=14) or TAU (n=15). Twenty-five patients (86%) provided complete datasets. Compared with TAU, RT led to reductions in AH distress in the large effect size range across T1 and T2. Our findings suggest that Relating Therapy might be effective for reducing AH distress. A larger, suitably powered phase 3 study is needed to provide a precise estimate of the effects of Relating Therapy for AH distress. [ABSTRACT FROM AUTHOR]

Background Context: Physical therapy is commonly sought by people with lumbar disc herniation and associated radiculopathy. It is unclear whether physical therapy is effective for this population.Purpose: To determine the effectiveness of physical therapist-delivered individualized functional restoration as an adjunct to guideline-based advice in people with lumbar disc herniation and associated radiculopathy.Study Design: This is a preplanned subgroup analysis of a multicenter parallel group randomized controlled trial.Patient Sample: The study included 54 participants with clinical features of radiculopathy (6-week to 6-month duration) and imaging showing a lumbar disc herniation.Outcome Measures: Primary outcomes were activity limitation (Oswestry Disability Index) and separate 0-10 numerical pain rating scales for leg pain and back pain. Measures were taken at baseline and at 5, 10, 26, and 52 weeks.Methods: The participants were randomly allocated to receive either individualized functional restoration incorporating advice (10 sessions) or guideline-based advice alone (2 sessions) over a 10-week period. Treatment was administered by 11 physical therapists at private clinics in Melbourne, Australia.Results: Between-group differences for activity limitation favored the addition of individualized functional restoration to advice alone at 10 weeks (7.7, 95% confidence interval [CI] 0.3-15.1) and 52 weeks (8.2, 95% CI 0.7-15.6), as well as back pain at 10 weeks (1.4, 95% CI 0.2-2.7). There were no significant differences between groups for leg pain at any follow-up. Several secondary outcomes also favored individualized functional restoration over advice.Conclusions: In participants with lumbar disc herniation and associated radiculopathy, an individualized functional restoration program incorporating advice led to greater reduction in activity limitation at 10- and 52-week follow-ups compared with guideline-based advice alone. Although back pain was significantly reduced at 10 weeks with individualized functional restoration, this effect was not maintained at later timepoints, and there were no significant effects on leg pain, relative to guideline-based advice. [ABSTRACT FROM AUTHOR]

Background: Client language is hypothesized to be a mechanism of action in motivational interviewing (MI). Despite the association of change and sustain talk with substance treatment outcomes, it not known whether providers can intentionally influence this language as hypothesized.Objective: This is a randomized controlled trial to investigate whether substance use providers can be trained to influence client language.Methods: Treatment providers specializing in substance use disorders (n=190) were randomly assigned to standard training in MI (MI-AU) or training emphasizing an influence of client language (MI-LEAF). Treatment sessions with actual clients were evaluated 3, 6 and 12 months after training by masked raters. Frequencies of client change and sustain talk were the outcome variables.Results: Sustain talk, but not change talk, was significantly lower in clients whose providers had received the specialized training (b=-0.175, SE=0.087, p=0.046, CI[-0.348 to 0.002], d=-0.325). Mediation analyses supported a causal chain between a) training, b) providers' attempts to minimize sustain talk in treatment sessions via directive reflective listening and c) client sustain talk in the treatment session (κ2=0.0833, bootstrap SE=0.0394, 95% CI [0.0148, 0.1691]).Conclusions: With specialized training, providers can reduce the amount of opposition language their clients offer when considering a change in their substance use. Demonstrating that client language is under partial control of the provider supports the feasibility of clinical trials to investigate the impact of shaping client language on treatment outcomes. [ABSTRACT FROM AUTHOR]

Background: Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions.Objectives: The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI.Methods: In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.Results: At 30 days, mortality in patients treated with either IABP or pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923).Conclusions: In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450). [ABSTRACT FROM AUTHOR]

Objective: Professional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient's perception of treatment credibility.Methods: We performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient's forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing.Results: All patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta=0.16 [95%CI 0.08 to 0.24]).Conclusion: In a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain.Practice Implication: Clinicians should dress comfortably without fear of losing credibility. [ABSTRACT FROM AUTHOR]

Context: Physical exercise can alleviate cancer-related fatigue. Randomized controlled trials in patients with advanced cancer are scarce.Objectives: We test the impact of a structured, individual sports program on fatigue in patients with advanced cancer.Methods: Seventy-seven patients were invited to participate in this randomized controlled trial exploring the effects of physical exercises on fatigue 12 and 24 weeks after baseline. Patients were randomized into three groups. Group A received treatment as usual, Group B was taught a structured, individual sports program, and Group C received additional ambulatory physiotherapeutical supervision. Primary outcome was general fatigue, secondary outcomes included rate of severe general fatigue, further dimensions of the Multidimensional Fatigue Inventory (MFI), as well as walking distance.Results: Mean score of general fatigue as well as other MFI subdimensions differed nonsignificantly between all groups at 12 weeks. However, the mental fatigue score demonstrated a statistically significant difference between the three groups. The rate of severe general fatigue was significantly reduced within Intervention Group C. Significant longitudinal change of MFI-dimension mental fatigue was found and reached the threshold for minimal clinically important difference, while all MFI-dimensions increased in Group A.Conclusion: Our results imply that tumor-patients' severe general fatigue can be reduced when patients conduct appropriate physical exercise. This study amends previous knowledge, as it describes the impact of outpatient physical exercise on fatigue in a heterogeneous patient cohort with various advanced cancer entities. Furthermore, this trial differentiates between patients with only a self-directed exercise program versus those receiving additional partially professional supervision. [ABSTRACT FROM AUTHOR]

Objective: To assess the impact of a preoperative educational intervention on the knowledge level of patients with spinal stenosis.Methods: One hundred spinal stenosis patients were randomized into a preoperative educational intervention group (IG, n=50) or a control group (CG, n=50). All the patients received routine preoperative education. In addition, the IG went through an empowering telephone discourse based on a knowledge test performed before admission to hospital. Data on patients' knowledge level were collected at baseline (after the treatment decision), admission to hospital, discharge from hospital and at 3 and 6 months follow-up.Results: At baseline, there was no difference in the knowledge level of the study groups. At admission, the knowledge level was significantly higher in five of six dimension of empowering knowledge in the IG compared to the CG. During follow-up, the knowledge level within the study groups remained stable.Conclusion: A preoperative KTFI significantly increased the patients' knowledge level in most dimensions of empowering knowledge.Practice Implication: KTFI is an effective method of preoperative education in patients with spinal stenosis. [ABSTRACT FROM AUTHOR]

Aims: Current adolescent alcohol treatments have modest effects and high relapse rates. Evaluation of novel pharmacotherapy treatment is warranted. N-acetylcysteine (NAC), an over-the-counter antioxidant supplement with glutamatergic properties, is a promising treatment for marijuana cessation in adolescents; however, its effects on adolescent drinking have not been examined. To that end, this secondary analysis evaluated: (1) the effect of NAC vs. placebo on alcohol use over an eight-week adolescent marijuana cessation trial and (2) the role of marijuana cessation and reduction on subsequent alcohol use.Methods: Marijuana-dependent adolescents (ages 15-21; N=116) interested in treatment were randomized to NAC 1200mg or matched placebo twice daily for eightweeks. Participants were not required to be alcohol users or interested in alcohol cessation to qualify.Results: There were no demographic or baseline alcohol use differences between participants randomized to NAC vs. placebo (ps>0.05). Of the 89 participants returning for ≥one visit following randomization, 77 reported ≥one alcoholic drink in the 30days prior to study entry and averaged 1.3 (SD=1.4) binge drinking days per week. During treatment, less marijuana use (measured via urine cannabinoid levels) was associated with less alcohol use in the NAC-treated group but not in the placebo-treated group (p=0.016).Conclusions: There was no evidence of compensatory alcohol use during marijuana treatment. In fact, in the NAC group, lower levels of marijuana use were associated with less alcohol use, suggesting NAC effects may generalize to other substances and could be useful in decreasing adolescent alcohol use. NAC trials specifically focused on alcohol-using adolescents are warranted. [ABSTRACT FROM AUTHOR]

Background: Effects on non-motor symptoms, mainly cognitive and psychiatric side effects, could influence the decision for either globus pallidus pars interna (GPi) or subthalamic nucleus (STN) deep brain stimulation (DBS) for patients with Parkinson's disease (PD).Objective: 1) To compare cognitive and psychiatric outcomes 3 years after GPi DBS versus STN DBS, and 2) to report on occurrence of suicidal ideation, psychiatric diagnoses, social functioning, and marital satisfaction 3 years after DBS.Methods: Patients were randomized to receive GPi DBS (n = 65) or STN DBS (n = 63). Standardized assessments were performed at baseline, 1 year, and 3 years. We used linear mixed model analyses to investigate between-group differences on the Mattis Dementia Rating Scale (MDRS), neuropsychological tests, and psychiatric questionnaires 3 years after DBS.Results: Eighty-seven patients (68%) completed at least one neuropsychological test after 3 years. No significant between-group differences were found on the MDRS (p = 0.61), neuropsychological tests (p-values between 0.17 and 0.87), and psychiatric questionnaires (p-values between 0.23 and 0.88) 3 years after DBS. The Mini International Neuropsychiatric Interview did not indicate a substantial number of psychiatric diagnoses after 3 years. Social functioning and marital satisfaction were comparable in both groups.Conclusions: Three years after GPi DBS and STN DBS no pronounced between-group differences on measures of cognitive and psychiatric functioning could be demonstrated. Overall, cognitive and psychiatric outcome 3 years after DBS do not provide a clear direction for clinicians when considering which of these two surgical targets to choose. [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]

Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n=69) or a wait-list condition (n=70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination-Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d=1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82≤d≤1.11). In the treatment group significant improvement was still observed for all measures 1year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED. [ABSTRACT FROM AUTHOR]