ClinicalTrials.gg
RecruitingNCT05722236Updated Sep 9, 2026

IBD Strong Peer2Peer for Self-Management of Psychological Distress

An interventional study of IBD Strong Peer2Peer and Waitlist control in Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease, sponsored by Jennifer Jones. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Jennifer Jones · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 5 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 155 studies in Inflammatory Bowel Diseases with a site in Canada — 35 open to participants now, 49 under way, 6 of them phase 3. Inflammatory Bowel Diseases · Canada.

Planned enrollment
60th of 118
120 · median 121
Started
2023
with 4 others
No phase
45 of 155
12 open now
Primary completion
2027-03
later than 18 of 48 live
Registered
121st of 155
by date

Among the 155 studies in Inflammatory Bowel Diseases with a site in Canada, this one is the 60th largest by planned enrollment of the 118 interventional ones that give a count, is one of 5 that started in 2023, is one of 45 with no phase, reaches primary completion later than 18 of the 48 other live ones, and was the 121st registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

35 of the 155 studies in Inflammatory Bowel Diseases with a site in Canada are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Inflammatory Bowel Diseases
  • Ulcerative Colitis
  • Crohn Disease

Keywords

  • peer mentoring
  • psychological distress
  • IBD
  • mental health
  • access
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    IBD Strong Peer2Peer intervention

    Behavioral: IBD Strong Peer2Peer

  • Other
    Waitlist -controls

    Other: Waitlist control

Interventions

  • BehavioralIBD 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.

  • OtherWaitlist control

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

06

What researchers measure

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

  5. Adherence rate

    Rate of participants who adhere to the study protocol

    Time frame: week 4

  6. Adherence rate

    Rate of participants who adhere to the study protocol

    Time frame: week 8

  7. Recruitment success

    recruitment success \[participation/ total number approached or referred\]

    Time frame: Pre-study Baseline

  8. Recruitment success

    recruitment success \[participation/ total number approached or referred\]

    Time frame: week 4

  9. Recruitment success

    recruitment success \[participation/ total number approached or referred\]

    Time frame: week 8

  10. Fidelity

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

    Time frame: week 1

  11. Fidelity

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

    Time frame: week 2

  12. Fidelity

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

    Time frame: week 3

  13. Fidelity

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

    Time frame: week 4

  14. Fidelity

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

    Time frame: week 5

  15. Fidelity

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

    Time frame: week 6

  16. Fidelity

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

    Time frame: week 7

  17. Fidelity

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

    Time frame: week 8

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

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

    Time frame: Pre-study Baseline

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

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

    Time frame: week 4

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

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

    Time frame: week 8

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

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

    Time frame: Pre-study baseline

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

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

    Time frame: week 4

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

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

    Time frame: week 8

  24. IBD Related quality of life score

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

    Time frame: Pre-study baseline

  25. IBD Related quality of life score

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

    Time frame: week 4

  26. IBD Related quality of life score

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

    Time frame: week 8

  27. Participant Self efficacy score

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

    Time frame: Pre-study Baseline

  28. Participant Self efficacy score

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

    Time frame: week 4

  29. Participant Self efficacy score

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

    Time frame: week 8

  30. Psychological distress (DSM-V)

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

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

  31. Psychological distress (DSM-V)

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

    Time frame: week 4

  32. Psychological distress (DSM-V)

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

    Time frame: week 8

  33. Psychological distress (PSS)

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

    Time frame: Pre-study Baseline

  34. Psychological distress (PSS)

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

    Time frame: week 4

  35. Psychological distress (PSS)

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

    Time frame: week 8

  36. Psychological distress (GAD7)

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

    Time frame: Pre-study Baseline

  37. Psychological distress (GAD7)

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

    Time frame: week 4

  38. Psychological distress (GAD7)

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

    Time frame: week 8

  39. Psychological distress (PHQ8)

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

    Time frame: Pre-study Baseline

  40. Psychological distress (PHQ8)

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

    Time frame: week 4

  41. Psychological distress (PHQ8)

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

    Time frame: week 8

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. PubMed 40243391 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Mar 2027, 45 months after the start.

Of 282 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 45 months is above that.

Counting every sponsor, half of 296 studies reached it within 27 months; a quarter within 14 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2022
First posted
Feb 10, 2023
StartActual
Jun 1, 2023
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05722236
Lead sponsor
Jennifer Jones
Collaborators
Crohn's and Colitis Canada, Nova Scotia Health Authority
Responsible party
Jennifer Jones (Clinical Gastroenterologist, Associate Professor, Department of Medicine, Dalhousie University, Nova Scotia Health Authority) — Sponsor-investigator
First posted
Feb 10, 2023
Start date
Jun 1, 2023
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Jennifer Jones, MD
Contact
jljones@dal.ca
902-473-1499
Natalie Willett, BSc
Contact
natalie.willett@nshealth.ca
902-473-7074

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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