Inflammatory Bowel Diseases-Specific Cognitive Behavioral Therapy Delivered Through Telehealth Reduces Disability: Addressing Disability Effectively With Psychosocial Telemedicine Pragmatic Randomized Controlled Trial

INTRODUCTION: Inflammatory bowel disease (IBD)-related disability encompasses physical and psychosocial dimensions, and it is under-recognized and under-treated in patients with IBD. Cognitive behavioral therapy (CBT) is a structured, time-limited, and problem-focused psychotherapy that targets inaccurate thoughts and maladaptive behaviors. We aimed to investigate the effect of IBD-specific CBT delivered through telehealth on disability in patients with IBD. METHODS: "Addressing Disability Effectively with Psychosocial Telemedicine" (NCT05635292) was an open-label, multicenter 1:2 randomized controlled trial for adults with moderate-to-severe IBD-related disability (assessed by the IBD Disability Index [IBD-DI]) to receive 8 weeks of telehealth-delivered CBT or usual care. Recruitment occurred between February and October 2023 at 5 gastroenterology clinics in the United States participating in the Crohn's & Colitis Foundation's Clinical Research Alliance. Clinical, demographic, disease activity, and psychological data were collected at baseline and at week 8. The primary end point was changes in IBD-DI (absolute change in IBD-DI score; clinically relevant improvement of 17-point decrease in IBD-DI), adjusted for IBD subtype and disease activity. The secondary outcomes were differences in direct and indirect costs between groups. Changes in IBD clinical disease activity was an exploratory end point. RESULTS: Ninety patients were randomized (74.4% Crohn's disease; 25.6% ulcerative colitis; 76.7% clinically active), of which 74 (82.2%) completed the trial and 69 (76.6%) adhered to the 8-week teletherapy protocol. Teletherapy group had significantly reduced disability (β = 5.9, P = 0.02) and clinically relevant improvements (adjusted odds ratio 2.9, 95% confidence interval 1.0-8.2 P = 0.04) compared with controls. Clinical disease activity and the cost of IBD (both direct and indirect) did not differ between the 2 groups. DISCUSSION: In a randomized controlled trial of patients with IBD, an 8-week telehealth-delivered IBD-specific CBT protocol reduced IBD-related disability, independent of clinical disease activity.