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RECRUITING Not applicable ClinicalTrials.gov

Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder

Sponsor: McMaster University • ClinicalTrials.gov ID: NCT07213492

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Group-Based Psychoeducation (Behavioral)
    Participants 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 (Behavioral)
    Trained 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 (Behavioral)
    The 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.

Eligibility criteria

Inclusion Criteria: * Age: Patient-participants must be between 18 and 35 years old. * Diagnosis: Must have been diagnosed with bipolar disorder within the past 24 months. * Clinical Features: Must have experienced psychosis and/or a lack of insight into their illness at the time of enrollment. * Language Proficiency: Must be able to understand and speak English. Exclusion Criteria: * Severe Psychiatric Conditions: Individuals with a severe psychiatric condition that would prevent them from safely engaging in the intervention. * Cognitive or Medical Impairment: Those with significant cognitive impairment or a medical condition that interferes with their ability to participate in psychoeducation or peer-support sessions. * Substance Use Disorder: Individuals with an active substance use disorder that may impact adherence to the intervention. * Language Barriers: Participants who do not speak English and are unable to engage in study sessions without language support. * Concurrent Participation in Similar Programs: Individuals who are already enrolled in another structured psychoeducational or peer-support program that could interfere with study outcomes.

Conditions

Bipolar Disorder (BD) Psychosis

Locations

  • St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record