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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Disorder (BD) Psychosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Multi-Modal Transitional Care Intervention

Participants 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.

Group Type EXPERIMENTAL

Group-Based Psychoeducation

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Group-Based Psychoeducation

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.

Intervention Type BEHAVIORAL

Peer Support

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.

Intervention Type BEHAVIORAL

Personalized Support for Community Healthcare Provider

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No