IBD Strong Peer2Peer for Self-Management of Psychological Distress

NCT05722236 | Recruiting

• 1 other identifier: 50596
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (41)

• Participant Satisfaction

  Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)

  week 4

• Participant Satisfaction

  Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)

  week 8

• Attrition rate

  Rate of participants who drop out of the study

  week 4

• Attrition rate

  Rate of participants who drop out of the study

  week 8

• Adherence rate

  Rate of participants who adhere to the study protocol

  week 4

• Adherence rate

  Rate of participants who adhere to the study protocol

  week 8

• Recruitment success

  recruitment success \[participation/ total number approached or referred\]

  Pre-study Baseline

• Recruitment success

  recruitment success \[participation/ total number approached or referred\]

  week 4

• Recruitment success

  recruitment success \[participation/ total number approached or referred\]

  week 8

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 1

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 2

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 3

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 4

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 5

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 6

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 7

• Fidelity

  Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  week 8

• General quality of life score (Eq5D-3L )

  General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  Pre-study Baseline

• General quality of life score (Eq5D-3L )

  General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  week 4

• General quality of life score (Eq5D-3L )

  General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  week 8

• General quality of life score (SF-36)

  General quality of life score measured by the SF-36 questionnaire

  Pre-study baseline

• General quality of life score (SF-36)

  General quality of life score measured by the SF-36 questionnaire

  week 4

• General quality of life score (SF-36)

  General quality of life score measured by the SF-36 questionnaire

  week 8

• IBD Related quality of life score

  IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  Pre-study baseline

• IBD Related quality of life score

  IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  week 4

• IBD Related quality of life score

  IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  week 8

• Participant Self efficacy score

  Self-efficacy, measured by the New General Self Efficacy Scale

  Pre-study Baseline

• Participant Self efficacy score

  Self-efficacy, measured by the New General Self Efficacy Scale

  week 4

• Participant Self efficacy score

  Self-efficacy, measured by the New General Self Efficacy Scale

  week 8

• Psychological distress (DSM-V)

  Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  Pre-study Baseline, week 4 and week 8

• Psychological distress (DSM-V)

  Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  week 4

• Psychological distress (DSM-V)

  Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  week 8

• Psychological distress (PSS)

  Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  Pre-study Baseline

• Psychological distress (PSS)

  Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  week 4

• Psychological distress (PSS)

  Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  week 8

• Psychological distress (GAD7)

  Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  Pre-study Baseline

• Psychological distress (GAD7)

  Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  week 4

• Psychological distress (GAD7)

  Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  week 8

• Psychological distress (PHQ8)

  Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

  Pre-study Baseline

• Psychological distress (PHQ8)

  Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

  week 4

• Psychological distress (PHQ8)

  Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

  week 8

Study Arms (2)

IBD Strong Peer2Peer intervention

EXPERIMENTAL

Behavioral: IBD Strong Peer2Peer

Waitlist -controls

OTHER

Other: Waitlist control

Interventions

IBD Strong Peer2Peer BEHAVIORAL

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.

IBD Strong Peer2Peer intervention

Waitlist control OTHER

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

Waitlist -controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Jones: lead
• Crohn's and Colitis Canada: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (1)

QEII Health Sciences Centre

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

RECRUITING

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Psychological Well-Being

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Jennifer Jones, MD

CONTACT

902-473-1499; jljones@dal.ca

Natalie Willett, BSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 10, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CA (1)