Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 13
- 主要终点
- Symptoms of depression
研究概览
简要总结
This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.
详细描述
The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.
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
- Double (Care Provider, Investigator)
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
- •Age ≥ 18 years
- •Diagnosis of ischemic heart disease (diagnostic codes I20-I25)
- •Referred for CR
- •HADS score ≥ 8 on depression and or anxiety
- •Access to a computer or smart phone
- •Ability to use computer or smart phone
- •Proficient in the Danish language
- •Signing an informed consent form
排除标准
- •Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder)
- •Severe cognitive difficulties (e.g. severe brain damage, mental retardation, or dementia) that will prevent patients from participating
- •Endorsement of suicidal ideation with daily suicidal thoughts (PHQ-9 item 9 >2)
- •Participation in other intervention studies (unless they are clinical studies)
- •Seeing a psychologist or mental health professional for the treatment of anxiety and depression
结局指标
主要结局
Symptoms of depression
时间窗: 3 months
Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
次要结局
- Symptoms of depression(12 months)
- Patient-reported Quality of life(12 months)
- Symptoms of anxiety(12 months)
- Patient-reported quality of life(6 months)
- Dropout(3 months)
- Health complaints(12 months)
- Cost-effectiveness(12 months)
- Perceived Stress(12 months)