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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
Jennifer Jones
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 22, 2022
    Last Updated
    February 1, 2023
    Sponsor
    Jennifer Jones
    Collaborators
    Crohn's and Colitis Canada, Nova Scotia Health Authority
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    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