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Recruiting NCT07213492

NCT07213492 Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder

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Clinical Trial Summary
NCT ID NCT07213492
Status Recruiting
Phase
Sponsor McMaster University
Condition Bipolar Disorder (BD)
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2026-06-01
Primary Completion 2027-05-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 35 Years
Study Type INTERVENTIONAL
Interventions
Group-Based PsychoeducationPeer SupportPersonalized Support for Community Healthcare Provider

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2026-06-01 with a primary completion date of 2027-05-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Fabiano A. Gomes, MD, Ph.D.

✉ gomesfs@mcmaster.ca

📞 905-522-1155

Frequently Asked Questions

Who can join the NCT07213492 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Bipolar Disorder (BD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07213492 currently recruiting?

Yes, NCT07213492 is actively recruiting participants. Contact the research team at gomesfs@mcmaster.ca for enrollment information.

Where is the NCT07213492 trial being conducted?

This trial is being conducted at Hamilton, Canada.

Who is sponsoring the NCT07213492 clinical trial?

NCT07213492 is sponsored by McMaster University. The trial plans to enroll 10 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology