Psychosocial Group Interventions for Depression: Systemic and Neurophysiological Correlates of Treatment Effect. A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
A total of 384 patients suffering from chronic depressive disorder will be randomized to receive treatment as usual, CBASP, or befriending for a period of five months. The primary outcome is change in Montgomery-Åsberg Depression Scale. Secondary outcomes include changes in self-reported psychiatric symptoms, biomarkers determined from venous blood samples, and neurophysiological parameters. The data gathering is performed at pre- and post intervention stages (i.e., at baseline and at five months). A follow-up questionnaire is sent to the participants six months after the intervention.
详细描述
The efficacy of 20-week group-CBASP as compared to TAU is evaluated by RCT in a psychiatric outpatient clinics. The recruition is completed.
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
- 否
入选标准
- •Age 18-65
- •Moderate or severe major depression with duration of a minimum of two years OR "double depression" (dysthymia and moderate/severe major depression simultaneously) OR moderate or severe major depression with duration of a minimum of two years, only partially remitted during the time period
排除标准
- •Psychotic disorder
- •Bipolar disorder
- •Current substance abuse (excluding nicotine)
研究组 & 干预措施
CBASP
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
干预措施: Treatment as usual (Other)
Befriending
Befriending is a social support intervention
干预措施: Treatment as usual (Other)
CBASP
Cognitive Behavioral System of Psychotherapy is a manual-based group intervention for chr depression (20 weeks).
干预措施: CBASP (Behavioral)
Befriending
Befriending is a social support intervention
干预措施: CBASP (Behavioral)
Treatment as usual
Conventional psychiatric outpatient treatment (individual counseling)
干预措施: CBASP (Behavioral)
Treatment as usual
Conventional psychiatric outpatient treatment (individual counseling)
干预措施: Befriending (Behavioral)
结局指标
主要结局
Depression
时间窗: At baseline and after intervention (at 5 months)
Montgomery-Åsberg Depression Rating Scale
次要结局
- Peripheral blood biomarkers(At baseline and after intervention (at 5 mos))