A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 29
- 主要终点
- Change in Anxiety (difference between the intervention and the control group)
研究概览
简要总结
The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).
详细描述
Major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (CVD) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after MI will be randomized either to a 14 week Internet-based CBT-program or to treatment as usual (TAU) which is the control condition. A reference group of 250 participants without depressive or anxiety symptoms will also be studied during TAU. Data will be collected before, after and 7 months after treatment. Anxiety and depression according to ratings on the Hospital Anxiety and Depression Scale (HADS) are the primary outcome measures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients younger than 75 years with a recent acute MI (< 3 months)
- •Depression and/or anxiety score of > 7 on one or both of the HADS subscales (concerns only the intervention, not the reference group)
排除标准
- •Patients that are scheduled for a coronary artery bypass surgery (CABG)
- •Unable or unwilling to use computer or Internet
- •Difficulties in reading or understanding Swedish
- •A life expectancy of less than a year
- •Anticipated poor compliance (multi-disease, substance abuse etc.)
- •Highly depressed or suicidal (MADRS-score > 29 or MADRS item 9 > 3)
结局指标
主要结局
Change in Anxiety (difference between the intervention and the control group)
时间窗: At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Change in Depression (difference between the intervention and the control group)
时间窗: At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)
次要结局
- Change in Quality of Life (difference between the intervention and the control group)(At baseline, during, after (3 months after baseline) and 7 months after treatment)
- Change in Perceived Social Support (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Stress behaviors (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Fatigue (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Sleeping Problems (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Cardiac Anxiety (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Posttraumatic Stress (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Posttraumatic Growth (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Quality of the Intervention(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change to Follow-up in Anxiety (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change to Follow-up in Depression (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
研究者
Louise-von Essen
Programme Director for U-CARE
Uppsala University