Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. OBJECTIVE: This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. METHODS: This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. RESULTS: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. CONCLUSIONS: The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14309.

Enhancing peer support experience for patients discharged from acute psychiatric care: protocol for a randomised controlled pilot trial.

INTRODUCTION: This study will evaluate the effectiveness of an innovative peer support programme. The programme incorporates leadership training, mentorship, recognition and reward systems for peer support workers, and supportive/reminder text messaging for patients discharged from acute (hospital) care. We hypothesise that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. METHODS AND ANALYSIS: This is a prospective, rater-blinded, four-arm randomised controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomised to one of four conditions: (1) enrolment in a peer support system; (2) enrolment in a peer support system plus automated daily supportive/reminder text messages; (3) enrolment in automated daily supportive/reminder text messages alone; or (4) treatment as usual follow-up care. Patients in each group will complete evaluation measures (eg, recovery, general symptomatology and functional outcomes) at baseline, 6 months and 12months. Patient service utilisation data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analysed with descriptive statistics, repeated measures and correlational analyses. The peer support worker experience will be captured using qualitative methods. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). The study has received ethical clearance from the Health Ethics Research Board of the University of Alberta (Ref # Pro00078427) and operational approval from our regional health authority (AHS- (PRJ) #35293). All participants will provide informed consent prior to study inclusion. The results will be disseminated at several levels, including patients/peer supports, practitioners, academics/researchers, and healthcare organisations. TRIAL REGISTRATION NUMBER: NCT03404882; Pre-results.

Suicide intent and accurate expectations of lethality: predictors of medical lethality of suicide attempts.

The degree of intent to commit suicide and the severity of self-injury were examined in individuals (N = 180) who had recently attempted suicide. Although a minimal association was found between the degree of suicide intent and the degree of lethality of the attempt, the accuracy of expectations about the likelihood of dying was found to moderate the relationship between suicide intent and lethality. Specifically, higher levels of suicide intent were associated with more lethal attempts but only for those individuals who had more accurate expectations about the likelihood of dying from their attempts.