Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of enrolled participants who complete the treatment
研究概览
简要总结
The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery.
详细描述
Cardiac surgery is a major surgical procedure used to treat for example coronary artery disease (CAD). The intervention increases survival rates and reduces cardiac symptom burden in cardiac patients. However, cardiac surgery is associated with elevated symptoms of psychological distress, which are related to several negative outcomes, such as poorer health-related quality of life (QoL) and response to treatment. There is a clear need to develop a brief psychological intervention that can be provided early in the clinical course after cardiac surgery to reduce psychological distress.
The purpose of this pilot study is to evaluate the feasibility and potential efficacy of a brief, exposure-based internet-delivered CBT protocol provided early after cardiac surgery. This is an uncontrolled pilot study with a pretest-posttest design. The study will include 30 participants. Assessments will be conducted pre-treatment, post-treatment, one- and six months after treatment. The one-month follow-up is the primary endpoint.
The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •(A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair or combined CABG and valve repair/replacement) ≥ eight weeks to nine months before assessment
- •(B) Age 18 years and above;
- •(C) Endorses postoperative psychological distress and/or interference with daily life
- •(D) On medical treatment for the cardiac condition according to clinical guidelines;
- •(E) Ability to read and write in Swedish
排除标准
- •(F) Prior cardiac surgery with ventricular assist device or heart transplant;
- •(G) Hospitalized or living in a care facility;
- •(H) Any medical restriction to be physical active;
- •(I) Severe medical illness i.e., terminal cancer ;
- •(J) Severe psychiatric disorder or risk of suicide;
- •(K) Alcohol dependency;
- •(L) Ongoing psychological treatment.
结局指标
主要结局
Percentage of enrolled participants who complete the treatment
时间窗: Baseline to 5 weeks
Feasibility of the intervention components will be assessed by \>60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.
Adverse events
时间窗: Baseline to 5 weeks
Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').
Acceptability: Client satisfaction Questionnaire
时间窗: Baseline to 5 weeks.
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
12-Item Short-Form Health Survey
时间窗: Baseline to 2 months
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
次要结局
- Generalized Anxiety Disorder 7-item(Baseline to 7 months)
- 12-Item Short-Form Health Survey(Baseline to 7 months)
- Cardiac anxiety questionnaire(Baseline to 7 months)
- Brief Pain Inventory Short Form(Baseline to 7 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(Baseline to 7 months)
- Patient Health Questionnaire-9(Baseline to 7 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(Baseline to 7 months)
- Multidimensional fatigue inventory(Baseline to 7 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 7 months)
研究者
Josefin Särnholm
PhD, Lic. Psychologist
Karolinska Institutet