Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder
- Sponsor
- McMaster University
- Study ID
- NCT07213492
- Status
- Recruiting
Conditions
- Bipolar Disorder (BD)
- Psychosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 35 Years
- Healthy Volunteers
- Not accepted
Interventions
- Group-Based Psychoeducation — BEHAVIORALParticipants attend a six-session, group-based psychoeducation program delivered over 8 weeks. Sessions focus on improving insight into bipolar disorder, relapse prevention, lifestyle strategies (e.g., sleep, nutrition, substance use), and digital literacy. The aim is to enhance understanding of illness and support long-term functioning.
- Peer Support — BEHAVIORALTrained peer support workers provide biweekly sessions over 6 months to participants. The sessions are based on the CANMAT/ISBD Patient and Family Guide and include emotional support, psychoeducation, and shared experience. Each participant receives up to 12 sessions aimed at improving engagement and understanding of illness.
- Personalized Support for Community Healthcare Provider — BEHAVIORALThe research team provides two personalized support sessions over 6 months to each participant's healthcare provider (e.g., family doctor or psychiatrist). Support includes treatment recommendations based on the CANMAT/ISBD 2018 Guidelines and training on the C-IMPACT BD web-based clinical decision support tool.
Study Details
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.
Key Dates
- First listed
- Oct 9, 2025
- Start date
- Jun 1, 2026
- Status verified
- Jan 2026
- Primary completion
- May 1, 2027
- Completion
- May 1, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Multi-Modal Transitional Care InterventionParticipants receive a 6-month structured intervention including: (1) 6 sessions of group-based psychoeducation, (2) biweekly peer support for individuals and families, and (3) two sessions of personalized clinical guidance for community healthcare providers.
Primary Outcome Measure
Feasibility of the Multi-Modal Transitional Care Intervention [ Time Frame: From enrollment to the end of intervention at 6 months. ]
Central Contacts
- Fabiano A. Gomes, MD, Ph.D.905-522-1155
- Daniela Giansante, MSc
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