IBD Strong Peer2Peer for Self-Management of Psychological Distress

September 4, 2026 updated by: Jennifer Jones

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jennifer Jones, MD
  • Phone Number: 902-473-1499
  • Email: jljones@dal.ca

Study Locations

  • Canada
    • N.S.
      • Halifax, N.S., Canada, B3H 3A7
        • Recruiting
        • QEII Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IBD Strong Peer2Peer intervention
Behavioral: IBD 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.
Other: Waitlist -controls
Other: Waitlist control
Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant Satisfaction
Time Frame: week 4
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
week 4
Participant Satisfaction
Time Frame: week 8
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
week 8
Attrition rate
Time Frame: week 4
Rate of participants who drop out of the study
week 4
Attrition rate
Time Frame: week 8
Rate of participants who drop out of the study
week 8
Adherence rate
Time Frame: week 4
Rate of participants who adhere to the study protocol
week 4
Adherence rate
Time Frame: week 8
Rate of participants who adhere to the study protocol
week 8
Recruitment success
Time Frame: Pre-study Baseline
recruitment success [participation/ total number approached or referred]
Pre-study Baseline
Recruitment success
Time Frame: week 4
recruitment success [participation/ total number approached or referred]
week 4
Recruitment success
Time Frame: week 8
recruitment success [participation/ total number approached or referred]
week 8
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).
week 1
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).
week 2
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).
week 3
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).
week 4
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).
week 5
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).
week 6
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).
week 7
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).
week 8
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
Pre-study Baseline
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
week 4
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
week 8
General quality of life score (SF-36)
Time Frame: Pre-study baseline
General quality of life score measured by the SF-36 questionnaire
Pre-study baseline
General quality of life score (SF-36)
Time Frame: week 4
General quality of life score measured by the SF-36 questionnaire
week 4
General quality of life score (SF-36)
Time Frame: week 8
General quality of life score measured by the SF-36 questionnaire
week 8
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)
Pre-study baseline
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)
week 4
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)
week 8
Participant Self efficacy score
Time Frame: Pre-study Baseline
Self-efficacy, measured by the New General Self Efficacy Scale
Pre-study Baseline
Participant Self efficacy score
Time Frame: week 4
Self-efficacy, measured by the New General Self Efficacy Scale
week 4
Participant Self efficacy score
Time Frame: week 8
Self-efficacy, measured by the New General Self Efficacy Scale
week 8
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
Pre-study Baseline, week 4 and week 8
Psychological distress (DSM-V)
Time Frame: week 4
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
week 4
Psychological distress (DSM-V)
Time Frame: week 8
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
week 8
Psychological distress (PSS)
Time Frame: Pre-study Baseline
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Pre-study Baseline
Psychological distress (PSS)
Time Frame: week 4
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
week 4
Psychological distress (PSS)
Time Frame: week 8
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
week 8
Psychological distress (GAD7)
Time Frame: Pre-study Baseline
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Pre-study Baseline
Psychological distress (GAD7)
Time Frame: week 4
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
week 4
Psychological distress (GAD7)
Time Frame: week 8
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
week 8
Psychological distress (PHQ8)
Time Frame: Pre-study Baseline
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Pre-study Baseline
Psychological distress (PHQ8)
Time Frame: week 4
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
week 4
Psychological distress (PHQ8)
Time Frame: week 8
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jennifer Jones

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nova Scotia Health Authority
Crohn's and Colitis Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 50596

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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