IBD Strong Peer2Peer for Self-Management of Psychological Distress

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease
• Interventions: Other: Waitlist control; Behavioral: IBD Strong Peer2Peer

• Registration Number: NCT05722236
• Lead Sponsor: Jennifer Jones

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Study Start: 2023-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist -controls	Waitlist control	-
IBD Strong Peer2Peer intervention	IBD Strong Peer2Peer	-

Primary Outcome Measures

Name	Time	Method
IBD Related quality of life score	week 8	IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
General quality of life score (SF-36)	week 8	General quality of life score measured by the SF-36 questionnaire
Recruitment success	week 8	recruitment success \[participation/ total number approached or referred\]
Fidelity	week 8	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
General quality of life score (Eq5D-3L )	week 8	General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
Psychological distress (DSM-V)	week 8	Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Attrition rate	week 8	Rate of participants who drop out of the study
Adherence rate	week 8	Rate of participants who adhere to the study protocol
Participant Satisfaction	week 8	Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)
Participant Self efficacy score	week 8	Self-efficacy, measured by the New General Self Efficacy Scale
Psychological distress (PSS)	week 8	Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (GAD7)	week 8	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (PHQ8)	week 8	Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, N.S., Canada