Internet-guided Cognitive Behavioural Therapy to Improve Depression in Patients With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Purpose and aims Tailored internet-based cognitive behavioural therapy (I-CBT) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (CVD). In patients with CVD, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. Depressive symptoms are both underdiagnosed and undertreated in CVD patients. Earlier studies have demonstrated the efficiency of cognitive behavioural therapy (CBT) for many psychiatric conditions, but few studies have evaluated CBT in patients with CVD.
The overall purpose of this study is to evaluate the effects of the tailored I-CBT program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (CVD) and to explore factors related to implementation of the I-CBT program in clinical cardiac care.
The primary aim:
-To evaluate the effects of the tailored I-CBT depression program on depressive symptoms.
Secondary aims:
- To evaluate effects on quality of life´, sleep and anxiety
- To evaluate factors that can influence the I-CBT programs effect on depressive symptoms.
- To gain knowledge about the I-CBT program, as perceived by patients and health care professionals.
- To explore facilitators and barriers to the implementation of the I-CBT program in clinical practice from the perspectives of patients, health care professionals and policymakers.
详细描述
Power calculation: Effect size=0.5, alpha=0.05 (Z=1.96), Power 0.80 (Z -0.84) = 122 participants. Due to drop-outs or deaths the size of the study population for the RCT study was decided to n=140.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment for CVD according to European Society of Cardiology guidelines.
- •stable CVD (NYHA class I-III) and not having been hospitalised for CVD in in the last four weeks.
- •depressive symptoms (Patient Health Questionnaire-9 17 (PHQ-9) > 5 points)
排除标准
- •severe CVD (NYHA IV) or another severe chronic life-threatening disease
- •severe depression assessed as requiring acute treatment
- •not being able to dedicate 3-4 hours to participate in the program
结局指标
主要结局
Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Score at 9 weeks follow-up
The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off \>5 represents minor depression and a cut off \>10 represents major depression
次要结局
未报告次要终点
研究者
Peter Johansson
RN, PhD, Professor
University Hospital, Linkoeping