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NCT Number: NCT05722236

IBD Strong Peer2Peer for Self-Management of Psychological Distress

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.

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Key information

Conditions

Inflammatory Bowel Diseases Behavior Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Personal Satisfaction Psychological Well-Being Ulcerative Colitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Sciences Centre

Halifax, N.S., B3H 3A7, Canada

Location status: Recruiting

Location contact

Jennifer L Jones, MD

CONTACT

[email protected]

902-473-1499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Participant Satisfaction

    Time frame: week 4

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

  2. Participant Satisfaction

    Time frame: week 8

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

  3. Attrition rate

    Time frame: week 4

    Rate of participants who drop out of the study

  4. Attrition rate

    Time frame: week 8

    Rate of participants who drop out of the study

  5. Adherence rate

    Time frame: week 4

    Rate of participants who adhere to the study protocol

  6. Adherence rate

    Time frame: week 8

    Rate of participants who adhere to the study protocol

  7. Recruitment success

    Time frame: Pre-study Baseline

    recruitment success [participation/ total number approached or referred]

  8. Recruitment success

    Time frame: week 4

    recruitment success [participation/ total number approached or referred]

  9. Recruitment success

    Time frame: week 8

    recruitment success [participation/ total number approached or referred]

  10. Fidelity

    Time frame: week 1

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  11. Fidelity

    Time frame: week 2

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  12. Fidelity

    Time frame: week 3

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  13. Fidelity

    Time frame: week 4

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  14. Fidelity

    Time frame: week 5

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  15. Fidelity

    Time frame: week 6

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  16. Fidelity

    Time frame: week 7

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  17. Fidelity

    Time frame: week 8

    Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).

  18. General quality of life score (Eq5D-3L )

    Time frame: Pre-study Baseline

    General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  19. General quality of life score (Eq5D-3L )

    Time frame: week 4

    General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  20. General quality of life score (Eq5D-3L )

    Time frame: week 8

    General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index

  21. General quality of life score (SF-36)

    Time frame: Pre-study baseline

    General quality of life score measured by the SF-36 questionnaire

  22. General quality of life score (SF-36)

    Time frame: week 4

    General quality of life score measured by the SF-36 questionnaire

  23. General quality of life score (SF-36)

    Time frame: week 8

    General quality of life score measured by the SF-36 questionnaire

  24. IBD Related quality of life score

    Time frame: Pre-study baseline

    IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  25. IBD Related quality of life score

    Time frame: week 4

    IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  26. IBD Related quality of life score

    Time frame: week 8

    IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  27. Participant Self efficacy score

    Time frame: Pre-study Baseline

    Self-efficacy, measured by the New General Self Efficacy Scale

  28. Participant Self efficacy score

    Time frame: week 4

    Self-efficacy, measured by the New General Self Efficacy Scale

  29. Participant Self efficacy score

    Time frame: week 8

    Self-efficacy, measured by the New General Self Efficacy Scale

  30. Psychological distress (DSM-V)

    Time frame: Pre-study Baseline, week 4 and week 8

    Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  31. Psychological distress (DSM-V)

    Time frame: week 4

    Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  32. Psychological distress (DSM-V)

    Time frame: week 8

    Participant psychological distress, measured by the DSM-V cross cutting questionnaire

  33. Psychological distress (PSS)

    Time frame: Pre-study Baseline

    Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  34. Psychological distress (PSS)

    Time frame: week 4

    Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  35. Psychological distress (PSS)

    Time frame: week 8

    Participant psychological distress, measured by the Perceived Stress Scale (PSS)

  36. Psychological distress (GAD7)

    Time frame: Pre-study Baseline

    Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  37. Psychological distress (GAD7)

    Time frame: week 4

    Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  38. Psychological distress (GAD7)

    Time frame: week 8

    Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale

  39. Psychological distress (PHQ8)

    Time frame: Pre-study Baseline

    Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

  40. Psychological distress (PHQ8)

    Time frame: week 4

    Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

  41. Psychological distress (PHQ8)

    Time frame: week 8

    Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Jones, MD

CONTACT

[email protected]

902-473-1499

Natalie Willett, BSc

CONTACT

[email protected]

902-473-7074

Sponsors and collaborators

Lead sponsor

Jennifer Jones

Other

Collaborators

  • Crohn's and Colitis Canada
  • Nova Scotia Health Authority

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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