Randomized Controlled Trial of a Telephone Based Peer Support Intervention to Reduce Depressive Symptoms and Improve Social Support in Women With Coronary Heart Disease (CHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
研究概览
简要总结
In a randomized controlled trial the investigators intended to evaluate the effect of a telephone based peer support intervention on depressed or anxious women with coronary heart disease (CHD). The investigators intended to include 198 depressed or anxious women aged over 18 years with CHD. Participants were randomized to intervention (IG) or waiting list (WL). IG was offered immediate telephone-based contact to peer counselors while WL received the offer with a 6-month delay. All participants got at least one telephone call by a clinical psychologist (study information, feedback about the individual level of distress, proposal to get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived social support (F-SozU K-14). In an additional quasi-experimental trial, the investigators included 11 peer counselors and 11 matched controls not taking part in the intervention. Main outcome variables were mood states (POMS) and perceived social support (F-SozU K-14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •coronary heart disease
- •depressive symptoms (HADS >7)
- •insurants of former Kaufmännische Krankenkasse (KKH)-Allianz
- •German speaking
- •at least 18 years old
- •written informed consent
排除标准
- •hardness of hearing
- •severe somatic illness
- •current severe depressive episode or current suicidal tendency
- •severe mental illness (dementia, psychosis)
结局指标
主要结局
Change of Depressive Symptoms measured by PHQ-9 from baseline to 5 month
时间窗: Baseline (T1), after 5 month (T2), after 11 month (T3)
PHQ-9: Patient Health Questionnaire - Depression Scale
Change of perceived social support measured by F-SozU K-14 from baseline to 6 month
时间窗: Baseline (T0), 5 month after T1 (T2), after 11 month (T3)
F-SozU K-14: Fragebogen zur sozialen Unterstützung (Social Support Questionnaire)
次要结局
- Change of Symptoms of anxiety measured by HADS-A from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))
- Change of Self efficacy measured by SWE from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))
- Change of Quality of life measured by WHOQOL-BREF from baseline to 5 month(Baseline (T1), after 5 month (T2), after 11 month (T3))
研究者
Christoph Herrmann-Lingen
Prof. Dr.
University of Göttingen