A Randomized-controlled Trial (RCT) on the Efficacy of a New Online Intervention for Depression: MOOD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory (BDI)
研究概览
简要总结
The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Further aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction.
详细描述
The study aims to examine the efficacy and acceptance of a self-help internet intervention "MOOD" in a sample of individuals with depressive symptoms. It is tested whether depressive symptomatology decreases in the intervention group compared to a wait-list control group. Secondary aims are to ascertain changes in self-worth and quality of life, to assess subjective evaluation of the program and to examine whether expectations of the program's helpfulness would predict symptom reduction. During the intervention period of six weeks, participants of the intervention group have access to the online program MOOD. Prior and following this period both groups complete a pre- and post-assessment. Participants of the wait-list control group receive access to MOOD following the post-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of psychological strain and desire for treatment for depressive symptoms
- •internet access
- •sufficient command of the German language
排除标准
- •acute suicidality (as assessed with one item of the BDI)
- •lifetime diagnoses of bipolar disorder and psychosis
研究组 & 干预措施
MOOD
The online program "MOOD" is based on methods of cognitive behavior therapy (KVT) and contains elements of mindfulness and metacognition. Participants can contact a moderator (trained psychologists) if they have any questions. However, this function is optional. The program consists of nine interactive modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention.
干预措施: MOOD (Behavioral)
Control
The wait-list control group does not receive additional treatment. However, previously started therapies (psychotherapy/ psychopharmacotherapy) may be continued during the study. Individuals of the wait-list control group receive access to MOOD after completion of the post-assessment.
结局指标
主要结局
Beck Depression Inventory (BDI)
时间窗: Change in BDI from baseline to post (intervention period is 6 weeks)
This questionnaire assesses symptoms of depression and their severity (Beck, Steer, \& Brown, 1996). It contains 21 items and the participant is asked to rate how severe he or she experiences each symptom on a 4-point Likert scale ranging from 0 (not at all severe) to 3 (extreme form of each symptom).
次要结局
- Subjective appraisal(Only at post-assessment (6 weeks))
- Rosenberg self-esteem scale (RSE)(Change in RSE from baseline to post (intervention period is 6 weeks))
- WHOQOL-Bref(Change in WHOQOL-Bref from baseline to post (intervention period is 6 weeks))
- University of Rhode Island Change Assessment (URICA)(Only at Baseline (pre intervention))
- Patient Health Questionnaire-9 Depression Module (PHQ-9)(Change in PHQ-9 from baseline to post (intervention period is 6 weeks))