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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
120
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.
Wait list controls will be offered participation in the IBD Strong Peer2Peer intervention once post-control outcome measures have been completed.
QEII Health Sciences Centre
Halifax, N.S., Canada
RECRUITINGParticipant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)
Time frame: week 4
Participant Satisfaction
Satisfaction, measured by the satisfaction questionnaire: QUOTE IBD, where QI index \< 0.9 = suboptimal satisfaction)
Time frame: week 8
Attrition rate
Rate of participants who drop out of the study
Time frame: week 4
Attrition rate
Rate of participants who drop out of the study
Time frame: week 8
Adherence rate
Rate of participants who adhere to the study protocol
Time frame: week 4
Adherence rate
Rate of participants who adhere to the study protocol
Time frame: week 8
Recruitment success
recruitment success \[participation/ total number approached or referred\]
Time frame: Pre-study Baseline
Recruitment success
recruitment success \[participation/ total number approached or referred\]
Time frame: week 4
Recruitment success
recruitment success \[participation/ total number approached or referred\]
Time frame: week 8
Fidelity
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
Fidelity
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
Fidelity
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
Fidelity
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
Fidelity
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
Fidelity
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
Fidelity
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
Fidelity
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
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
Time frame: 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
Time frame: 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
Time frame: week 8
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Time frame: Pre-study baseline
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Time frame: week 4
General quality of life score (SF-36)
General quality of life score measured by the SF-36 questionnaire
Time frame: week 8
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Pre-study baseline
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: week 4
IBD Related quality of life score
IBD Related quality of life score, measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: week 8
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Time frame: Pre-study Baseline
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Time frame: week 4
Participant Self efficacy score
Self-efficacy, measured by the New General Self Efficacy Scale
Time frame: week 8
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time frame: Pre-study Baseline, week 4 and week 8
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time frame: week 4
Psychological distress (DSM-V)
Participant psychological distress, measured by the DSM-V cross cutting questionnaire
Time frame: week 8
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time frame: Pre-study Baseline
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time frame: week 4
Psychological distress (PSS)
Participant psychological distress, measured by the Perceived Stress Scale (PSS)
Time frame: week 8
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time frame: Pre-study Baseline
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time frame: week 4
Psychological distress (GAD7)
Participant psychological distress, measured by the Generalized Anxiety Disorder Assessment (GAD7) scale
Time frame: week 8
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time frame: Pre-study Baseline
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time frame: week 4
Psychological distress (PHQ8)
Participant psychological distress, measured by the eight-item Patient Health Questionnaire depression (PHQ8) scale
Time frame: week 8
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