Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Knowledge level
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Clinical Group
Participants will receive treatment as usual (TAU) associated with the psychoeducational program.
干预措施: PEG-D program (Behavioral)
Clinical Group
Participants will receive treatment as usual (TAU) associated with the psychoeducational program.
干预措施: TAU (Drug)
Control Group
The usual treatment will consist of outpatient follow-up for a period of twelve months.
干预措施: TAU (Drug)
结局指标
主要结局
Knowledge level
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Ricardo Alberto Moreno, M.D., Ph.D.
PhD
University of Sao Paulo