Clinical Trial

IBD Strong Peer2Peer for Self-Management of Psychological Distress

Recruiting
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Record status
This record was last updated July 9, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
Psychological distress (PD) as a result of inflammatory bowel disease (IBD) is prevalent and associated with worse disease-related outcomes. IBD-associated psychological distress (IBD-PD) is particularly common at initial diagnosis, during disease flares, before surgery, and during transitions of care. Access to evidence-based, gold-standard psychological interventions and emotional support for IBD-PD has been identified as a major care gap by persons living with IBD. The COVID-19 pandemic has further exacerbated the burden of PD for persons living with chronic diseases like IBD, predisposing at-risk individuals to even greater mental struggles. Studies have shown a minority of patients are asked about IBD-PD in routine clinical care and that even if asked, access to mental health care is extremely limited. iPeer2Peer is an evidence-based, peer-led, virtually administered intervention for IBD-PD in the pediatric population that has demonstrated feasibility, acceptability and early effectiveness. Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD. This program, IBD Strong Peer, will be studied through a randomized, wait list-controlled hybrid implementation-effectiveness trial in Nova Scotia. This study will provide implementation data needed to improve and adapt the intervention and implementation strategy to meet local needs, as well as provide early effectiveness data. This data will inform the design and statistical power needed for future larger, multicenter randomized control trials. IBD Strong Peer has significant potential to improve access to evidence-informed interventions for IBD-PD.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-02-01; most recent amendment 2025-07-08.
Status change: Not Yet Recruiting → Recruiting 2023-11-24
Trial Details
NCT Number NCT05722236
Lead Sponsor Jennifer Jones
Collaborators: Crohn's and Colitis Canada, Nova Scotia Health Authority
Conditions Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Enrollment 120 participants
Start Date 2023-06-01
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-07-09