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IBD Strong Peer2Peer for Self-Management of Psychological Distress

J

Jennifer Jones

Status

Enrolling

Conditions

Ulcerative Colitis
Inflammatory Bowel Diseases
Crohn Disease

Treatments

Behavioral: IBD Strong Peer2Peer
Other: Waitlist control

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

IBD Strong Peer2Peer intervention
Experimental group
Treatment:
Behavioral: IBD Strong Peer2Peer
Waitlist -controls
Other group
Treatment:
Other: Waitlist control

Trial contacts and locations

1

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Central trial contact

Natalie Willett, BSc; Jennifer Jones, MD

Data sourced from clinicaltrials.gov

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