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Browse 3,090 clinical trials for depression. Find studies that match your criteria and connect with research centers.
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NCT03609749
The purpose of this study is to investigate changes in functional neural activation during self-regulation tasks before compared to after the Mindfulness Training for Primary Care intervention (see MINDFUL-PC (Phase 3) clinical trial). The study will also look at whether chronic disease self-management action plan initiation and successful engagement of self-report and behavioral self-regulation targets relates to the observed brain activation changes after compared to before the mindfulness intervention.
NCT03731728
INTRODUCTION: There is strong evidence indicating the effectiveness of Cognitive-Behavior Therapy (CBT) in the management of Major Depressive Disorder (MDD) and some clinical trials indicating physical exercise (PE) as an effective treatment for the disorder. However, few studies have evaluated the effect of group CBT or PE compared to wait-listing to receive treatment as usual (TAU) in the management of MDD. This study will evaluate and compare the effectiveness of: 1) group CBT plus wait-listing for TAU; versus 2) group PE plus wait-listing for TAU; versus 3) only wait-listing for TAU in management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or PE (plus wait-listed for TAU) arms of the study will achieve superior outcomes compared to participants only wait-listed for TAU. METHODS AND ANALYSIS: This is a prospective rater-blinded randomized controlled trial assessing the benefits for participants with MDD. 120 patients with MDD referred to Addiction and Mental Health (AMH) clinics in Edmonton Zone who are informed about the study and consent to participate will be randomly assigned to one of the 3 arms of the study: 1) 40 participants wait-listed for TAU will receive weekly sessions of group CBT for 14 weeks; 2) 40 participants wait-listed for TAU will receive PE 3 times a week for 14 weeks; and 3) 40 participants will only be wait-listed for TAU. Participants will be assessed at enrollment, 3 and 6 months post enrolment, mid-treatment, and at treatment completion . Their assessments will cover primary outcomes including functional variables (relationships, well-being, physical activity) and symptom variables (changes in depressive symptoms scores). Secondary client outcomes will be service variables (e.g. patient compliance, retention in treatment, patient satisfaction). In addition, participants in the intervention groups will 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. ETHICS AND DISSEMINATION: 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 has received ethical clearance from Health Ethics Research Board of the University of Alberta (Ref. # Pro 00080975) and operational approval from the provincial health authority (AHS # 43638). The results will be disseminated at several levels, including patients, practitioners, academics/researchers, and healthcare organizations.