Background

Despite the high prevalence of comorbid depression in people living with coronary artery disease (CAD), uptake of psychological treatment is generally low. This study was designed to investigate the feasibility of an internet-based cognitive-behavioral (iCBT) depression intervention for people with CAD and depressive symptoms. Methods: People with CAD and depressive symptoms (PHQ-9 ≥ 5) were randomly assigned to the eight modules comprising iCBT (N = 18), or waitlist-control (N = 16). Measures were taken at baseline (t1) and at post-treatment (eight weeks after randomization, t2). Feasibility-related outcomes were recruitment strategy, study attrition, intervention dropout, satisfaction, negative effects as well as the potential of the intervention to affect likely outcomes in a future full-scale trial (depression, anxiety, quality of life, fear of progression). Data analyses were based on intention-to-treat principles. Linear regression models were used to detect between group differences. Linear Mixed Models were used to model potential changes over time. Results: This trial was terminated prior to a-priori defined sample size has been reached given low recruitment success as well as high intervention dropout (88%) and study attrition (23%). On average, participants in the intervention group completed M = 2.78 (SD = 3.23) modules. Participants in the waitlist control group barely started one module (M = 0.82, SD = 1.81). The satisfaction with the intervention was low (M = 20.6, SD = 0.88). Participants reported no negative effects attributed to the iCBT. Differences between groups with regard to depression, anxiety, fear of progression and quality of life remained non-significant (p > 0.05). Conclusion: This trial failed to recruit a sufficient number of participants. Future work should explore potential pitfalls with regards to the reach and persuasiveness of internet interventions for people living with CAD. The study gives important indications for future studies with regard to the need for new ideas to reach and treat people with CAD and depression.

中文翻译：

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从“WIDeCAD”随机对照可行性试验中吸取的经验教训——一种针对冠状动脉疾病 (CAD) 患者的基于互联网的抑郁症治疗方法

背景

尽管冠状动脉疾病（CAD）患者合并抑郁症的患病率很高，但心理治疗的接受率普遍较低。本研究旨在调查基于互联网的认知行为 (iCBT) 抑郁干预对患有 CAD 和抑郁症状的患者的可行性。方法：患有 CAD 和抑郁症状 (PHQ-9 ≥ 5) 的患者被随机分配到包含 iCBT ( N  = 18) 或等候名单控制 ( N  = 16)的八个模块。在基线（t1）和治疗后（随机化后八周，t2）进行测量。与可行性相关的结果包括招募策略、研究流失、干预退出、满意度、负面影响以及干预影响未来全面试验中可能结果的潜力（抑郁、焦虑、生活质量、对进展的恐惧） 。数据分析基于意向治疗原则。使用线性回归模型来检测组间差异。线性混合模型用于模拟随时间的潜在变化。结果：鉴于招募成功率低、干预退出率高（88%）和研究流失率高（23%），该试验在达到先验定义的样本量之前终止。平均而言，干预组的参与者完成了M  = 2.78 ( SD  = 3.23) 个模块。等候名单对照组的参与者几乎没有开始一个模块（M  = 0.82，SD  = 1.81）。对干预的满意度较低（M  = 20.6，SD  = 0.88）。参与者报告没有 iCBT 带来的负面影响。各组之间在抑郁、焦虑、对进展的恐惧和生活质量方面的差异仍然不显着（p  > 0.05）。结论：该试验未能招募足够数量的参与者。未来的工作应探讨互联网干预对 CAD 患者的影响范围和说服力方面的潜在陷阱。这项研究为未来的研究提供了重要的指示，即需要新的想法来接触和治疗 CAD 和抑郁症患者。