IBD Strong Peer2Peer for Self-Management of Psychological Distress

A Randomized, Wait List-Controlled, Clinical Trial of IBD Strong Peer for Self-Management of Psychological Distress by Persons Living With Inflammatory Bowel Diseases (IBD)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: IBD Strong Peer2Peer; Other: Waitlist control

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Willett, BSc; Phone Number: 902-473-7074; Email: natalie.willett@nshealth.ca
• Study Contact Backup: Name: Jennifer Jones, MD; Phone Number: 902-473-1499; Email: jljones@dal.ca

Study Locations

• Canada
  • N.S.
    • Halifax, N.S., Canada, B3H 3A7
      • Recruiting
      • QEII Health Sciences Centre
      • Contact: Jennifer L Jones, MD; Phone Number: 902-473-1499; Email: jennifer.jones@nshealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBD Strong Peer2Peer intervention	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 -controls	Other: Waitlist control; Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jennifer Jones
• Collaborators: Nova Scotia Health Authority; Crohn's and Colitis Canada

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mental health; IBD; psychological distress; access; peer mentoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 50596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No