IBD Strong Peer2Peer for Self-Management of Psychological Distress

NCT05722236 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

IBD Strong Peer2Peer

Mentee participants will experience the intervention: this group will partake in peer-led sessions (peer calls) consisting of up to 10 virtual sessions on Zoom lasting approximately 20-30 minutes in duration over eight weeks. Individual peer calls will be unstructured whereby trained mentors (patients with IBD who have undergone training to be a mentor) and mentees will be given the freedom to discuss whatever issues they choose. Psychological and emotional support is provided to the mentee by the mentor.

OTHER

Waitlist control

Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.

Sponsors & Collaborators

  • Crohn's and Colitis Canada

    collaborator OTHER
  • Nova Scotia Health Authority

    collaborator OTHER
  • Jennifer Jones

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05722236 on ClinicalTrials.gov