IBD Strong Peer2Peer for Self-Management of Psychological Distress

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorJennifer Jones

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • IBD Strong Peer2Peer

    Behavioral

    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.

  • Waitlist control

    Other intervention

    Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: IBD Strong Peer2Peer interventionExperimental treatment 1 intervention
Group B: Waitlist -controlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Participant Satisfaction

Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)

Time frame
week 4
2

Participant Satisfaction

Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)

Time frame
week 8
3

Attrition rate

Rate of participants who drop out of the study

Time frame
week 4
4

Attrition rate

Rate of participants who drop out of the study

Time frame
week 8

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Jones

Lead sponsor

Nova Scotia Health Authority

Sponsor institution

Crohn's and Colitis Canada

Collaborator

Nova Scotia Health Authority

Collaborator