Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-01 @ 4:38 PM
Study NCT ID:
NCT07213492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
A Bridge to Better Days: A Pilot Study of a Multimodal Intervention to Support the Successful Transition From Hospital to Community Care for People Living With Bipolar Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BTBD
Brief Summary:
People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations. This open-label pilot trial will assess the feasibility, acceptability, and preliminary effectiveness of a structured care pathway to support the transition from hospital to community care. The intervention includes group-based psychoeducation, individual peer support, and personalized support for community healthcare providers to improve illness insight, treatment adherence, and symptom management.
Detailed Description:
This is a 6-month, open-label pilot study of the feasibility, acceptability, and preliminary effectiveness of a multimodal transitional-care intervention for individuals with BD who have recently been discharged from the hospital. The intervention comprises a brief group psychoeducation program (6 clinician-facilitated sessions delivered over up to 8 weeks), individualized peer support (biweekly one-on-one sessions for \~12 total across 6 months), and optional personalized support for participants' primary healthcare providers (two collaborative sessions over 6 months offering guideline-based recommendations and access/training to a clinical decision-support app). Ten patient-participants who meet the inclusion criteria will be enrolled over 6 months; this sample will be used to estimate recruitment, retention, adherence, satisfaction, and safety parameters, and to inform power and procedures for a subsequent randomized controlled trial. Participants will be recruited from St. Joseph's Healthcare Hamilton (SJHH) outpatient clinics, the community and the ENABLE research registry at SJHH (Hamilton, ON, Canada). Eligible adults are 18-35 years old with a BD diagnosis within the past 24 months and a history of psychosis and/or limited illness insight; all must meet inclusion/exclusion criteria and provide written informed consent. After obtaining consent, eligibility will be confirmed with the Mini-International Neuropsychiatric Interview (MINI) and the Mood Disorders Insight Scale (MDIS). Study visits occur at three timepoints: baseline, post-psychoeducation, and post-multimodal intervention (6 months). At each assessment time point, clinicians and/or patient-participants will complete validated measures; socio-demographic and clinical history will be collected at baseline. Feasibility will be assessed through recruitment, enrollment, adherence (session attendance/completion), and retention metrics; acceptability through patient-participant and healthcare-provider satisfaction questionnaires; and safety through prospective monitoring of emergent symptoms, acute relapse, emergency visits, hospitalizations, and suicide-related events. Data will be summarized primarily with descriptive statistics (means, standard deviations, frequencies); exploratory pre-post comparisons (e.g., t-tests or chi-square) will evaluate the signal of change in symptoms, insight, functioning, lifestyle, and quality of life. The results of this study will determine whether delivering a structured psychoeducation + peer-support + provider-support care pathway during the transition from hospital to community is feasible and acceptable for early-stage BD, and will guide sample-size calculations, procedures, and implementation strategies for a subsequent randomized controlled trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: