Clinical trial NCT05722236: IBD Strong Peer2Peer for Self-Management of Psychological Distress
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Keywords: peer mentoring
psychological distress
IBD
mental health
access
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Canada
name: Nova Scotia Health Authority
First posted: 2023-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Satisfaction
timeFrame: week 4
measure: Participant Satisfaction
timeFrame: week 8
measure: Attrition rate
timeFrame: week 4
measure: Attrition rate
timeFrame: week 8
measure: Adherence rate
timeFrame: week 4
measure: Adherence rate
timeFrame: week 8
measure: Recruitment success
timeFrame: Pre-study Baseline
measure: Recruitment success
timeFrame: week 4
measure: Recruitment success
timeFrame: week 8
measure: Fidelity
timeFrame: week 1
measure: Fidelity
timeFrame: week 2
measure: Fidelity
timeFrame: week 3
measure: Fidelity
timeFrame: week 4
measure: Fidelity
timeFrame: week 5
measure: Fidelity
timeFrame: week 6
measure: Fidelity
timeFrame: week 7
measure: Fidelity
timeFrame: week 8
measure: General quality of life score (Eq5D-3L )
timeFrame: Pre-study Baseline
measure: General quality of life score (Eq5D-3L )
timeFrame: week 4
measure: General quality of life score (Eq5D-3L )
timeFrame: week 8
measure: General quality of life score (SF-36)
timeFrame: Pre-study baseline
measure: General quality of life score (SF-36)
timeFrame: week 4
measure: General quality of life score (SF-36)
timeFrame: week 8
measure: IBD Related quality of life score
timeFrame: Pre-study baseline
measure: IBD Related quality of life score
timeFrame: week 4
measure: IBD Related quality of life score
timeFrame: week 8
measure: Participant Self efficacy score
timeFrame: Pre-study Baseline
measure: Participant Self efficacy score
timeFrame: week 4
measure: Participant Self efficacy score
timeFrame: week 8
measure: Psychological distress (DSM-V)
timeFrame: Pre-study Baseline, week 4 and week 8
measure: Psychological distress (DSM-V)
timeFrame: week 4
measure: Psychological distress (DSM-V)
timeFrame: week 8
measure: Psychological distress (PSS)
timeFrame: Pre-study Baseline
measure: Psychological distress (PSS)
timeFrame: week 4
measure: Psychological distress (PSS)
timeFrame: week 8
measure: Psychological distress (GAD7)
timeFrame: Pre-study Baseline
measure: Psychological distress (GAD7)
timeFrame: week 4
measure: Psychological distress (GAD7)
timeFrame: week 8
measure: Psychological distress (PHQ8)
timeFrame: Pre-study Baseline
measure: Psychological distress (PHQ8)
timeFrame: week 4
measure: Psychological distress (PHQ8)
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: N.S.
Study officials:
References: