Recruiting

Structured Care Pathway

Sponsor:

McMaster University

Code:

NCT07213492

Conditions

Bipolar Disorder (BD)

Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Group-Based Psychoeducation

Peer Support

Personalized Support for Community Healthcare Provider

Study Details

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.

Conditions

Bipolar Disorder (BD)

Psychosis

Study ID

NCT07213492

Start date

Jun 1, 2026

Status verified date

Jan, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Feasibility of the Multi-Modal Transitional Care Intervention [ Time Frame: From enrollment to the end of intervention at 6 months. ]
  • Acceptability of the Multi-Modal Transitional Care Intervention [ Time Frame: Administered at the end of the intervention (Month 6). ]

Central Contacts and Locations

Central contacts

Fabiano A. Gomes, MD, Ph.D.

905-522-1155gomesfs@mcmaster.ca

Daniela Giansante, MSc

giansand@mcmaster.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 3K7

Contacts

Fabiano A. Gomes, MD, Ph.D.

905-522-1155fgomes@stjoes.ca

Daniela Giansante, MSc

dgiansan@stjoes.ca

Principal Investigator:

Fabiano A. Gomes, MD, Ph.D.

More Information

Sponsor

McMaster University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Bipolar Disorder
  • Psychoeducation
  • Insight
  • Psychosis
  • Multimodal Intervention
  • Early-Stage Bipolar Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-01-14.