基于认知行为疗法的针对老年抑郁患者的个体化互联网模块式干预研究方案：一项随机对照试验
A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial.
机构信息
Institute of Psychology, Vilnius University, Vilnius, Lithuania.
Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
出版信息
Trials. 2021 Dec 16;22(1):925. doi: 10.1186/s13063-021-05903-4.
BACKGROUND
Depression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT).
METHODS
A minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and within- and between-group effect sizes will be calculated.
DISCUSSION
Internet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04728204. Registered on 15 January 2021. https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1.
背景
抑郁症在老年人中最为常见，且与严重功能障碍相关。由于可获得的治疗方法有限，因此需要提供远程干预。基于互联网的干预措施已被证明对许多精神和躯体健康问题有效。然而，在以前的研究中，老年人群体受到的关注相对较少。本研究旨在通过调查基于认知行为疗法（CBT）的定制化互联网模块式干预措施的有效性来弥补这一空白。
方法
将招募至少 60 名参与者，并在一项两臂平行对照试验中按随机分组，分为两组，一组为有等待期的对照组，一组为实验组。实验组将获得为期 8 周的由治疗师支持的模块式干预。对照组将被指示等待 8 周，然后获得 8 周的干预。计划进行预评估、后评估以及 3、12 和 24 个月的随访评估，以使用 PHQ-9、GDS、GAD-7 和 WHO-5 评估抑郁症状、焦虑症状和心理幸福感的变化。所有参与者的主要结果将采用意向性治疗原则进行分析，并计算组内和组间的效应量。
讨论
基于互联网的干预措施可能有助于解决现有老年抑郁症患者的治疗缺口。然而，迄今为止，基于互联网的 CBT（ICBT）对老年抑郁症患者的有效性仅在少数研究中进行了测试。本试验将证明与等待名单对照组相比，基于互联网的 CBT 对该人群是否有效。对干预措施的次要结果和参与者行为的进一步分析可能会揭示有效性的调节因素。
试验注册
ClinicalTrials.gov NCT04728204。注册于 2021 年 1 月 15 日。https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1.
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