COMBAT‐DS 2021.
Study name | Online cognitive behavioral therapy for depressive symptoms in rural patients with cardiac disease (COMBAT‐DS) |
Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 500 (also states 150 per group; stratified by sex) Length of follow‐up: 12 months from baseline Analysis: not specified |
Participants | Location: USA Number of study centres and setting: not specified, affiliated with University of Kentucky, University of California, Patient‐Centered Outcomes Research Institute CAD criteria: physician‐documented acute coronary syndrome event Depression criteria: at least moderate depressive symptoms (PHQ‐9 ≥ 10) Other entry criteria: rural dwelling Exclusion criteria: cognitive impairment, major psychiatric comorbidities that might require additional treatment, presence of non‐CHD conditions likely to be fatal within next year |
Interventions | Intervention 1: video‐conferenced CBT (vcCBT) consisting of 8 face‐to‐face video‐conferencing sessions via tablet computers lasting approximately 45 minutes each Intervention 2: iCBT is self‐directed cognitive‐behavioural therapy using an interactive internet programme, MoodGYM, which does not include direct interactions with a therapist Duration of treatment: 3 months |
Outcomes | Primary: change in depressive symptoms as a result of intervention effects on PHQ‐9 Seconday: all‐cause hospitalisation rates |
Starting date | 3 August 2021 |
Contact information | Debra K Moser PhD, RN Professor and Linda C Gill Endowed Chair of Nursing University of Kentucky, Lexington, Kentucky, United States T: 859‐323‐6687 E: dmoser@uky.edu Misook Chung University of Kentucky, Lexington, Kentucky, United States T: 8593236687 E: misook.chung@uky.edu Rana Rahman, PhD, RN University of Kentucky, Lexington, Kentucky, United States T: 8593236656 E: rana.lindsay‐rahman@uky.edu |
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