Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Crohn's and Colitis Canada | OTHER |
| Nova Scotia Health Authority | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD Strong Peer2Peer intervention | Experimental |
| |
| Waitlist -controls | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction) | week 4 |
| Participant Satisfaction | Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction) | week 8 |
| Attrition rate | Rate of participants who drop out of the study | week 4 |
| Attrition rate | Rate of participants who drop out of the study | week 8 |
| Adherence rate | Rate of participants who adhere to the study protocol | week 4 |
| Adherence rate | Rate of participants who adhere to the study protocol | week 8 |
| Recruitment success | recruitment success [participation/ total number approached or referred] | Pre-study Baseline |
| Recruitment success | recruitment success [participation/ total number approached or referred] | week 4 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Jones, MD | Contact | 902-473-1499 | jljones@dal.ca | |
| Natalie Willett, BSc | Contact | 902-473-7074 | natalie.willett@nshealth.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QEII Health Sciences Centre | Recruiting | Halifax | N.S. | B3H 3A7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Waitlist control | Other | Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed. |
|
| Recruitment success | recruitment success [participation/ total number approached or referred] | week 8 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 1 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 2 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 3 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 4 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 5 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 6 |
| Fidelity | Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis). | week 7 |
| Fidelity | 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 ) | 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 ) | 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 ) | 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) | General quality of life score measured by the SF-36 questionnaire | Pre-study baseline |
| General quality of life score (SF-36) | General quality of life score measured by the SF-36 questionnaire | week 4 |
| General quality of life score (SF-36) | General quality of life score measured by the SF-36 questionnaire | week 8 |
| IBD Related quality of life score | IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | Pre-study baseline |
| IBD Related quality of life score | IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | week 4 |
| IBD Related quality of life score | IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | week 8 |
| Participant Self efficacy score | Self-efficacy, measured by the New General Self Efficacy Scale | Pre-study Baseline |
| Participant Self efficacy score | Self-efficacy, measured by the New General Self Efficacy Scale | week 4 |
| Participant Self efficacy score | Self-efficacy, measured by the New General Self Efficacy Scale | week 8 |
| Psychological distress (DSM-V) | Participant psychological distress, measured by the DSM-V cross cutting questionnaire | Pre-study Baseline, week 4 and week 8 |
| Psychological distress (DSM-V) | Participant psychological distress, measured by the DSM-V cross cutting questionnaire | week 4 |
| Psychological distress (DSM-V) | Participant psychological distress, measured by the DSM-V cross cutting questionnaire | week 8 |
| Psychological distress (PSS) | Participant psychological distress, measured by the Perceived Stress Scale (PSS) | Pre-study Baseline |
| Psychological distress (PSS) | Participant psychological distress, measured by the Perceived Stress Scale (PSS) | week 4 |
| Psychological distress (PSS) | Participant psychological distress, measured by the Perceived Stress Scale (PSS) | week 8 |
| Psychological distress (GAD7) | Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale | Pre-study Baseline |
| Psychological distress (GAD7) | Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale | week 4 |
| Psychological distress (GAD7) | Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale | week 8 |
| Psychological distress (PHQ8) | Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale | Pre-study Baseline |
| Psychological distress (PHQ8) | Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale | week 4 |
| Psychological distress (PHQ8) | Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale | week 8 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |