Inflammatory Bowel DiseasesNCT05722236
IBD Strong Peer2Peer for Self-Management of Psychological Distress
A study testing IBD Strong Peer2Peer in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Jennifer Jones at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- IBD Strong Peer2Peer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
QEII Health Sciences Centre
Halifax, N.S., B3H 3A7
Jennifer L Jones, MD, 902-473-1499, jennifer.jones@nshealth.ca
About this study
Official 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)
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.
- Being tested
- IBD Strong Peer2Peer, Waitlist control
- Keywords
- peer mentoring, psychological distress, IBD, mental health, access
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD Strong Peer2PeerBehavioural
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 controlOther
Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.
| Study group | Role | What they receive |
|---|---|---|
| IBD Strong Peer2Peer intervention | Experimental | Not described Receives: Behavioral: IBD Strong Peer2Peer |
| Waitlist -controls | Other | Not described Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Measured: week 4
Participant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Measured: week 8
Attrition rate
Rate of participants who drop out of the study
Measured: week 4
Attrition rate
Rate of participants who drop out of the study
Measured: week 8
Adherence rate
Rate of participants who adhere to the study protocol
Measured: week 4
Adherence rate
Rate of participants who adhere to the study protocol
Measured: week 8
Recruitment success
recruitment success [participation/ total number approached or referred]
Measured: Pre-study Baseline
Recruitment success
recruitment success [participation/ total number approached or referred]
Measured: week 4
Recruitment success
recruitment success [participation/ total number approached or referred]
Measured: week 8
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 1
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 2
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 3
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 4
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 5
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 6
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 7
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Measured: week 8
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
Measured: Pre-study Baseline
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
Measured: week 4
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
Measured: week 8
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Measured: Pre-study baseline
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Measured: week 4
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Measured: week 8
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: Pre-study baseline
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: week 4
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: week 8
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Measured: Pre-study Baseline
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Measured: week 4
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Measured: week 8
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Measured: Pre-study Baseline, week 4 and week 8
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Measured: week 4
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Measured: week 8
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Measured: Pre-study Baseline
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Measured: week 4
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Measured: week 8
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Measured: Pre-study Baseline
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Measured: week 4
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Measured: week 8
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Measured: Pre-study Baseline
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Measured: week 4
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jun 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Canada, Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Jennifer Jones, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722236
- Sponsor's protocol ID
- 50596
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05722236
- Acronym / sponsor ID
- 50596
- Keywords
- peer mentoring, psychological distress, IBD, mental health, access
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jennifer JonesUniversity, hospital or other
- Collaborators
- Crohn's and Colitis Canada, Nova Scotia Health Authority
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD Strong Peer2Peer intervention | Experimental | Behavioral: IBD Strong Peer2Peer |
| Waitlist -controls | Other | Other: Waitlist control |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBD Strong Peer2PeerMentee 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. | Behavioural | IBD Strong Peer2Peer intervention |
| Waitlist controlWait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed. | Other | Waitlist -controls |
Primary outcome
Participant Satisfaction
Time frame: week 4
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Participant Satisfaction
Time frame: week 8
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Attrition rate
Time frame: week 4
Rate of participants who drop out of the study
Attrition rate
Time frame: week 8
Rate of participants who drop out of the study
Adherence rate
Time frame: week 4
Rate of participants who adhere to the study protocol
Adherence rate
Time frame: week 8
Rate of participants who adhere to the study protocol
Recruitment success
Time frame: Pre-study Baseline
recruitment success [participation/ total number approached or referred]
Recruitment success
Time frame: week 4
recruitment success [participation/ total number approached or referred]
Recruitment success
Time frame: week 8
recruitment success [participation/ total number approached or referred]
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).
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).
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).
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).
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).
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).
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).
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).
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
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
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
General quality of life score (SF-36)
Time frame: Pre-study baseline
General quality of life score measured by the SF-36 questionnaire
General quality of life score (SF-36)
Time frame: week 4
General quality of life score measured by the SF-36 questionnaire
General quality of life score (SF-36)
Time frame: week 8
General quality of life score measured by the SF-36 questionnaire
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)
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)
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)
Participant Self efficacy score
Time frame: Pre-study Baseline
Self-efficacy, measured by the New General Self Efficacy Scale
Participant Self efficacy score
Time frame: week 4
Self-efficacy, measured by the New General Self Efficacy Scale
Participant Self efficacy score
Time frame: week 8
Self-efficacy, measured by the New General Self Efficacy Scale
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
Psychological distress (DSM-V)
Time frame: week 4
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Psychological distress (DSM-V)
Time frame: week 8
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Psychological distress (PSS)
Time frame: Pre-study Baseline
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (PSS)
Time frame: week 4
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (PSS)
Time frame: week 8
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (GAD7)
Time frame: Pre-study Baseline
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (GAD7)
Time frame: week 4
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (GAD7)
Time frame: week 8
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (PHQ8)
Time frame: Pre-study Baseline
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Psychological distress (PHQ8)
Time frame: week 4
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Psychological distress (PHQ8)
Time frame: week 8
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 40243391Tiles-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBD Strong Peer2Peer in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Jennifer Jones at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Jones, MD (902-473-1499, jljones@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction (time frame: week 4). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.