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

ConditionsBipolar Disorder (BD)Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Multi-Modal Transitional Care InterventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility of the Multi-Modal Transitional Care Intervention

Feasibility will be assessed using three descriptive indicators: 1) Recruitment rate: the proportion of eligible patient-participants and community healthcare providers who consent to participate. 2) Retention rate: the proportion of enrolled participants who remain in the study until the final follow-up. 3) Intervention adherence: participant adherence to each intervention component, including the number of sessions attended and number of dropouts. Each indicator will be analyzed separately to determine the feasibility of implementing the multi-modal transitional care intervention.

Time frame
From enrollment to the end of intervention at 6 months.
2

Acceptability of the Multi-Modal Transitional Care Intervention

Acceptability will be measured using post-intervention surveys completed by patient-participants and community healthcare providers. Surveys will assess satisfaction and perceived usefulness of the intervention using Likert-scale items, with the option to provide additional information via open-ended questions.

Time frame
Administered at the end of the intervention (Month 6).

Secondary outcomes

1

Change in Depression Symptoms (MADRS)

Clinician-rated 10-item scale assessing depressive symptoms over the past 7 days. Items are rated on a 7-point Likert scale, with higher scores indicating more severe symptoms.

Time frame
Baseline and Month 6 (end of intervention).
2

Change in Mania Symptoms (YMRS)

Clinician-rated 11-item scale assessing manic symptoms using clinical interview and observation. Items scored 0-4 or 0-8, with higher scores indicating more severe mania.

Time frame
Baseline and Month 6 (end of intervention).
3

Change in Anxiety Symptoms (GAD-7)

7-item self-report scale assessing anxiety over the past 2 weeks. Items scored 0-3; higher scores reflect greater anxiety.

Time frame
Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).
4

Change in Depression Severity (Patient Health Questionnaire) (PHQ-9)

9-item self-report scale evaluating the presence and severity of depression symptoms over the past 2 weeks. Each item scored 0-3; higher scores indicate greater severity.

Time frame
Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).

Other outcomes

1

Safety Monitoring: Relapse, Hospitalization, and Risk

Monitoring and documentation of adverse events including psychiatric relapse, hospitalizations, and suicide attempts throughout the intervention period.

Time frame
Throughout the 6-month intervention period.
2

Sociodemographic Factors

Demographic and clinical background data will be collected, including gender, age, ethnicity, marital status, education level, income, medical and psychiatric history, family history of psychiatric disorders, medication usage, and treatment history.

Time frame
Baseline and Month 6 (end of intervention).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

St. Joseph's Healthcare Hamilton

Collaborator

Source ClinicalTrials.gov
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