Recruiting

Observational Study

Sponsor:

Jennifer Jones

Code:

NCT05722236

Conditions

Inflammatory Bowel Diseases

Ulcerative Colitis

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IBD Strong Peer2Peer

Waitlist control

Study Details

Brief 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

Inflammatory Bowel Diseases

Ulcerative Colitis

Crohn Disease

Study ID

NCT05722236

Start date

Jun 1, 2023

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult IBD patient (18 years or older)
  • In a period of transition (newly diagnosed, transitioning from pediatric to adult care, flaring or changing medications, recently admitted to hospital, or facing the need for surgery)

Exclusion Criteria:

  • Screening positive for severe psychological pathology
  • Do not speak English
  • Diagnosis of a major comorbid psychiatric condition such as bipolar disorder or schizophrenia,
  • No access to the internet

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: IBD Strong Peer2Peer intervention

other: Waitlist -controls

Interventions

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.

Waitlist control

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

Primary outcome measure

  • Participant Satisfaction [ Time Frame: week 4 ]
  • Participant Satisfaction [ Time Frame: week 8 ]
  • Attrition rate [ Time Frame: week 4 ]
  • Attrition rate [ Time Frame: week 8 ]
  • Adherence rate [ Time Frame: week 4 ]
  • Adherence rate [ Time Frame: week 8 ]
  • Recruitment success [ Time Frame: Pre-study Baseline ]
  • Recruitment success [ Time Frame: week 4 ]
  • Recruitment success [ Time Frame: week 8 ]
  • Fidelity [ Time Frame: week 1 ]
  • Fidelity [ Time Frame: week 2 ]
  • Fidelity [ Time Frame: week 3 ]
  • Fidelity [ Time Frame: week 4 ]
  • Fidelity [ Time Frame: week 5 ]
  • Fidelity [ Time Frame: week 6 ]
  • Fidelity [ Time Frame: week 7 ]
  • Fidelity [ Time Frame: week 8 ]
  • General quality of life score (Eq5D-3L ) [ Time Frame: Pre-study Baseline ]
  • General quality of life score (Eq5D-3L ) [ Time Frame: week 4 ]
  • General quality of life score (Eq5D-3L ) [ Time Frame: week 8 ]
  • General quality of life score (SF-36) [ Time Frame: Pre-study baseline ]
  • General quality of life score (SF-36) [ Time Frame: week 4 ]
  • General quality of life score (SF-36) [ Time Frame: week 8 ]
  • IBD Related quality of life score [ Time Frame: Pre-study baseline ]
  • IBD Related quality of life score [ Time Frame: week 4 ]
  • IBD Related quality of life score [ Time Frame: week 8 ]
  • Participant Self efficacy score [ Time Frame: Pre-study Baseline ]
  • Participant Self efficacy score [ Time Frame: week 4 ]
  • Participant Self efficacy score [ Time Frame: week 8 ]
  • Psychological distress (DSM-V) [ Time Frame: Pre-study Baseline, week 4 and week 8 ]
  • Psychological distress (DSM-V) [ Time Frame: week 4 ]
  • Psychological distress (DSM-V) [ Time Frame: week 8 ]
  • Psychological distress (PSS) [ Time Frame: Pre-study Baseline ]
  • Psychological distress (PSS) [ Time Frame: week 4 ]
  • Psychological distress (PSS) [ Time Frame: week 8 ]
  • Psychological distress (GAD7) [ Time Frame: Pre-study Baseline ]
  • Psychological distress (GAD7) [ Time Frame: week 4 ]
  • Psychological distress (GAD7) [ Time Frame: week 8 ]
  • Psychological distress (PHQ8) [ Time Frame: Pre-study Baseline ]
  • Psychological distress (PHQ8) [ Time Frame: week 4 ]
  • Psychological distress (PHQ8) [ Time Frame: week 8 ]

Central Contacts and Locations

Central contacts

Jennifer Jones, MD

902-473-1499jljones@dal.ca

Natalie Willett, BSc

902-473-7074natalie.willett@nshealth.ca

Locations

QEII Health Sciences Centre

Recruiting

Halifax, N.S., Canada, B3H 3A7

Contacts

Jennifer L Jones, MD

902-473-1499jennifer.jones@nshealth.ca

More Information

Sponsor

Jennifer Jones

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • peer mentoring
  • psychological distress
  • IBD
  • mental health
  • access

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jennifer Jones on 2026-09-09.