IBD Strong Peer2Peer for Self-Management of Psychological Distress
Primary Purpose
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IBD Strong Peer2Peer
Waitlist control
Sponsored by
About this trial
This is an interventional health services research trial for Inflammatory Bowel Diseases focused on measuring peer mentoring, psychological distress, IBD, mental health, access
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
IBD Strong Peer2Peer intervention
Waitlist -controls
Arm Description
Outcomes
Primary Outcome Measures
Participant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Participant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Attrition rate
Rate of participants who drop out of the study
Attrition rate
Rate of participants who drop out of the study
Adherence rate
Rate of participants who adhere to the study protocol
Adherence rate
Rate of participants who adhere to the study protocol
Recruitment success
recruitment success [participation/ total number approached or referred]
Recruitment success
recruitment success [participation/ total number approached or referred]
Recruitment success
recruitment success [participation/ total number approached or referred]
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
Audio recording of session to determine what interventions were delivered, intervention fidelity (Module content completion will be assessed via thematic analysis).
Fidelity
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 )
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 )
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 )
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)
General quality of life score measured by the SF-36 questionnaire
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05722236
First Posted
December 22, 2022
Last Updated
February 1, 2023
Sponsor
Jennifer Jones
Collaborators
Crohn's and Colitis Canada, Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT05722236
Brief Title
IBD Strong Peer2Peer for Self-Management of Psychological Distress
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Jones
Collaborators
Crohn's and Colitis Canada, Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Keywords
peer mentoring, psychological distress, IBD, mental health, access
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBD Strong Peer2Peer intervention
Arm Type
Experimental
Arm Title
Waitlist -controls
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
IBD Strong Peer2Peer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist control
Intervention Description
Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.
Primary Outcome Measure Information:
Title
Participant Satisfaction
Description
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Time Frame
week 4
Title
Participant Satisfaction
Description
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index < 0.9 = suboptimal satisfaction)
Time Frame
week 8
Title
Attrition rate
Description
Rate of participants who drop out of the study
Time Frame
week 4
Title
Attrition rate
Description
Rate of participants who drop out of the study
Time Frame
week 8
Title
Adherence rate
Description
Rate of participants who adhere to the study protocol
Time Frame
week 4
Title
Adherence rate
Description
Rate of participants who adhere to the study protocol
Time Frame
week 8
Title
Recruitment success
Description
recruitment success [participation/ total number approached or referred]
Time Frame
Pre-study Baseline
Title
Recruitment success
Description
recruitment success [participation/ total number approached or referred]
Time Frame
week 4
Title
Recruitment success
Description
recruitment success [participation/ total number approached or referred]
Time Frame
week 8
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
Fidelity
Description
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
Title
General quality of life score (Eq5D-3L )
Description
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
Title
General quality of life score (Eq5D-3L )
Description
General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
Time Frame
week 4
Title
General quality of life score (Eq5D-3L )
Description
General quality of life score measured by the European Quality of Life 5 Dimensions 3 Level Version (Eq5D-3L) index
Time Frame
week 8
Title
General quality of life score (SF-36)
Description
General quality of life score measured by the SF-36 questionnaire
Time Frame
Pre-study baseline
Title
General quality of life score (SF-36)
Description
General quality of life score measured by the SF-36 questionnaire
Time Frame
week 4
Title
General quality of life score (SF-36)
Description
General quality of life score measured by the SF-36 questionnaire
Time Frame
week 8
Title
IBD Related quality of life score
Description
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
Pre-study baseline
Title
IBD Related quality of life score
Description
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
week 4
Title
IBD Related quality of life score
Description
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time Frame
week 8
Title
Participant Self efficacy score
Description
Self-efficacy, measured by the New General Self Efficacy Scale
Time Frame
Pre-study Baseline
Title
Participant Self efficacy score
Description
Self-efficacy, measured by the New General Self Efficacy Scale
Time Frame
week 4
Title
Participant Self efficacy score
Description
Self-efficacy, measured by the New General Self Efficacy Scale
Time Frame
week 8
Title
Psychological distress (DSM-V)
Description
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time Frame
Pre-study Baseline, week 4 and week 8
Title
Psychological distress (DSM-V)
Description
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time Frame
week 4
Title
Psychological distress (DSM-V)
Description
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time Frame
week 8
Title
Psychological distress (PSS)
Description
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time Frame
Pre-study Baseline
Title
Psychological distress (PSS)
Description
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time Frame
week 4
Title
Psychological distress (PSS)
Description
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time Frame
week 8
Title
Psychological distress (GAD7)
Description
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time Frame
Pre-study Baseline
Title
Psychological distress (GAD7)
Description
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time Frame
week 4
Title
Psychological distress (GAD7)
Description
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time Frame
week 8
Title
Psychological distress (PHQ8)
Description
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time Frame
Pre-study Baseline
Title
Psychological distress (PHQ8)
Description
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time Frame
week 4
Title
Psychological distress (PHQ8)
Description
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Jones, MD
Phone
902-473-1499
Email
jljones@dal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Willett, BSc
Phone
902-473-7074
Email
natalie.willett@nshealth.ca
12. IPD Sharing Statement
Learn more about this trial
IBD Strong Peer2Peer for Self-Management of Psychological Distress
We'll reach out to this number within 24 hrs