IBD Strong Peer2Peer for Self-Management of Psychological Distress

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Behavioral: IBD Strong Peer2Peer
* Other: Waitlist control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological distress, peer mentoring, IBD, mental health, access