Evaluation of an Adaptable and Personcentered Internet-based CBT Program Aimed to Treat Stress, Anxiety and Depressive Symptoms 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
- 215
- 试验地点
- 1
- 主要终点
- Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
研究概览
简要总结
To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD.
详细描述
All patients diagnosed as CVD (i.e. diagnosis Ischemia (ICD-code I20., I25.), Heart Failure (ICD-code I50., I42.) or Arrhythmia (ICD-code I48, I49, DF016) and who received care in the last 12 months at hospitals in the south-east of Sweden will be contacted by letter with information about the study.
Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse.
Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses.
Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •age 18 years and above
- •treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines
- •stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks.
- •stress (Perceived Stress Scale (PSS)-10>13 points) and/or
- •anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or
- •depressive symptoms (Patient Health Questionnaire-9 28 (PHQ-9) > 5 points)
排除标准
- •severe CVD (New York Heart Association classification IV) or another severe chronic life-threatening disease
- •severe stress, anxiety or depression assessed as requiring acute treatment
- •not being able to dedicate 3-4 hours per week to participate in the program
研究组 & 干预措施
Design of the CBT treatment content
Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content
干预措施: internet-based cognitive behavioral theraphy (Behavioral)
Control of support and feedback
Patient-controlled support and feedback (person-centred) vs. therapist -controlled.
干预措施: internet-based cognitive behavioral theraphy (Behavioral)
结局指标
主要结局
Change in anxiety from baseline to 9 weeks on the 7-item Generalized Anxiety Disorder Scale.
时间窗: From baseline to 9 weeks at the end of the intervention.
General Anxiety Disorder scale is validagted self-resport that measure symptoms of general anxiety during the last two weeks. The 7-items range from 0 (not bothered at all) to 3 (nearly every day). A higher score indicate more anxiety and the cut-off 5 suggests at least mild anxiety.
Change in stress from baseline to 9 weeks on the 10 item Perceived Stress Scale
时间窗: From baseline to 9 weeks at the end of the intervention.
The 10-item Perceived Stress Scale is a valideted self-report of Stress. The instreument measures the degree to which individuals perceives their life situations as stressful. The 10 items are rated on a 5 point scale and higher scores means more stress
Change in depressive symptoms from baseline to 9 weeks on the 9 item Patient Health Questionnaire.
时间窗: From baseline to 9 weeks at the end of the intervention.
The 9-item Patient Health Questionnaire is a validated self-report that measure depressive symtpoms during the last two weeks. Each item is answered on a four graded scale where 0 means that the person not is affected and 3 where the person is affected several Days to almost every day. Higher numbers represents higher levels of depressive symptoms. A cut-off \>5 represents at least mild depression.
次要结局
未报告次要终点
研究者
Peter Johansson
Professor
Linkoeping University