IBD Strong Peer2Peer for Self-Management of Psychological Distress

Ulcerative Colitis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722236
• Other study ID #: 50596
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Nova Scotia Health Authority
• Contact: Jennifer Jones, MD
• Phone: 902-473-1499
• Email: jljones[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

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

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	N.S.

Sponsors (3)

Lead Sponsor	Collaborator
Jennifer Jones	Crohn's and Colitis Canada, Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Satisfaction	Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)	week 4
Primary	Participant Satisfaction	Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)	week 8
Primary	Attrition rate	Rate of participants who drop out of the study	week 4
Primary	Attrition rate	Rate of participants who drop out of the study	week 8
Primary	Adherence rate	Rate of participants who adhere to the study protocol	week 4
Primary	Adherence rate	Rate of participants who adhere to the study protocol	week 8
Primary	Recruitment success	recruitment success [participation/ total number approached or referred]	Pre-study Baseline
Primary	Recruitment success	recruitment success [participation/ total number approached or referred]	week 4
Primary	Recruitment success	recruitment success [participation/ total number approached or referred]	week 8
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 1
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 2
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 3
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 4
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 5
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 6
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 7
Primary	Fidelity	Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).	week 8
Primary	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
Primary	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
Primary	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
Primary	General quality of life score (SF-36)	General quality of life score measured by the SF-36 questionnaire	Pre-study baseline
Primary	General quality of life score (SF-36)	General quality of life score measured by the SF-36 questionnaire	week 4
Primary	General quality of life score (SF-36)	General quality of life score measured by the SF-36 questionnaire	week 8
Primary	IBD Related quality of life score	IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	Pre-study baseline
Primary	IBD Related quality of life score	IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	week 4
Primary	IBD Related quality of life score	IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	week 8
Primary	Participant Self efficacy score	Self-efficacy, measured by the New General Self Efficacy Scale	Pre-study Baseline
Primary	Participant Self efficacy score	Self-efficacy, measured by the New General Self Efficacy Scale	week 4
Primary	Participant Self efficacy score	Self-efficacy, measured by the New General Self Efficacy Scale	week 8
Primary	Psychological distress (DSM-V)	Participant psychological distress, measured by the DSM-V cross cutting questionnaire	Pre-study Baseline, week 4 and week 8
Primary	Psychological distress (DSM-V)	Participant psychological distress, measured by the DSM-V cross cutting questionnaire	week 4
Primary	Psychological distress (DSM-V)	Participant psychological distress, measured by the DSM-V cross cutting questionnaire	week 8
Primary	Psychological distress (PSS)	Participant psychological distress, measured by the Perceived Stress Scale (PSS)	Pre-study Baseline
Primary	Psychological distress (PSS)	Participant psychological distress, measured by the Perceived Stress Scale (PSS)	week 4
Primary	Psychological distress (PSS)	Participant psychological distress, measured by the Perceived Stress Scale (PSS)	week 8
Primary	Psychological distress (GAD7)	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale	Pre-study Baseline
Primary	Psychological distress (GAD7)	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale	week 4
Primary	Psychological distress (GAD7)	Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale	week 8
Primary	Psychological distress (PHQ8)	Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale	Pre-study Baseline
Primary	Psychological distress (PHQ8)	Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale	week 4
Primary	Psychological distress (PHQ8)	Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale	week 8