Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
Overview
- Phase
- Not Applicable
- Intervention
- PEG-D program
- Conditions
- Major Depressive Disorder (MDD
- Sponsor
- Ricardo Alberto Moreno, M.D., Ph.D.
- Enrollment
- 338
- Locations
- 1
- Primary Endpoint
- Knowledge level
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression
Investigators
Ricardo Alberto Moreno, M.D., Ph.D.
PhD
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Clinical Group
Participants will receive treatment as usual (TAU) associated with the psychoeducational program.
Intervention: PEG-D program
Clinical Group
Participants will receive treatment as usual (TAU) associated with the psychoeducational program.
Intervention: TAU
Control Group
The usual treatment will consist of outpatient follow-up for a period of twelve months.
Intervention: TAU
Outcomes
Primary Outcomes
Knowledge level
Time Frame: Time: baseline, post 6 weeks and 12 months.
Learning quiz: Comprising of open and closed questions questions, it was designed to evaluate participants' level of knowledge regarding depression
Depressive levels
Time Frame: Baseline, post 6 weeks, 3, 6 and 12 months.
Beck Depression Inventory-BDI-II. It consists of 21 items and measures the intensity of depression in the last 14 days. The instrument has 21 items, and the higher the score, the greater the intensity of depression.
Secondary Outcomes
- Depressive Thoughts(Baseline, post 6 weeks, 3, 6 and 12 months)
- Avoidance behaviors(Baseline, post 6 weeks, 3, 6 and 12 months.)
- Functionality(Baseline, post 6 weeks, 3, 6 and 12 months.)