IBD Strong Peer2Peer for Self-Management of Psychological Distress
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Participant Satisfaction [week 4]
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
- Participant Satisfaction [week 8]
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
- Attrition rate [week 4]
Rate of participants who drop out of the study
- Attrition rate [week 8]
Rate of participants who drop out of the study
- Adherence rate [week 4]
Rate of participants who adhere to the study protocol
- Adherence rate [week 8]
Rate of participants who adhere to the study protocol
- Recruitment success [Pre-study Baseline]
recruitment success [participation/ total number approached or referred]
- Recruitment success [week 4]
recruitment success [participation/ total number approached or referred]
- Recruitment success [week 8]
recruitment success [participation/ total number approached or referred]
- Fidelity [week 1]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 2]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 3]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 4]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 5]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 6]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- Fidelity [week 7]
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
- 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 ) [Pre-study Baseline]
General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
- General quality of life score (Eq5D-3L ) [week 4]
General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
- 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
- General quality of life score (SF-36) [Pre-study baseline]
General quality of life score measured by the SF-36 questionnaire
- General quality of life score (SF-36) [week 4]
General quality of life score measured by the SF-36 questionnaire
- General quality of life score (SF-36) [week 8]
General quality of life score measured by the SF-36 questionnaire
- IBD Related quality of life score [Pre-study baseline]
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
- IBD Related quality of life score [week 4]
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
- IBD Related quality of life score [week 8]
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
- Participant Self efficacy score [Pre-study Baseline]
Self-efficacy, measured by the New General Self Efficacy Scale
- Participant Self efficacy score [week 4]
Self-efficacy, measured by the New General Self Efficacy Scale
- Participant Self efficacy score [week 8]
Self-efficacy, measured by the New General Self Efficacy Scale
- Psychological distress (DSM-V) [Pre-study Baseline, week 4 and week 8]
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
- Psychological distress (DSM-V) [week 4]
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
- Psychological distress (DSM-V) [week 8]
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
- Psychological distress (PSS) [Pre-study Baseline]
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
- Psychological distress (PSS) [week 4]
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
- Psychological distress (PSS) [week 8]
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
- Psychological distress (GAD7) [Pre-study Baseline]
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
- Psychological distress (GAD7) [week 4]
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
- Psychological distress (GAD7) [week 8]
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
- Psychological distress (PHQ8) [Pre-study Baseline]
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
- Psychological distress (PHQ8) [week 4]
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
- Psychological distress (PHQ8) [week 8]
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult IBD patient (18 years or older)
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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:
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Screening positive for severe psychological pathology
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Do not speak English
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Diagnosis of a major comorbid psychiatric condition such as bipolar disorder or schizophrenia,
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No access to the internet
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jennifer Jones
- Crohn's and Colitis Canada
- Nova Scotia Health Authority
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 50596