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

NCT07213492 | Recruiting

• 1 other identifier: 18669
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of intervention at 6 months.

• 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.

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

Secondary Outcomes (9)

• Change in Depression Symptoms (MADRS)

  Baseline and Month 6 (end of intervention).

• Change in Mania Symptoms (YMRS)

  Baseline and Month 6 (end of intervention).

• Change in Anxiety Symptoms (GAD-7)

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

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

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

• Change in Insight (MDIS)

  Baseline and Month 6 (end of intervention).

Other Outcomes (2)

• Safety Monitoring: Relapse, Hospitalization, and Risk

  Throughout the 6-month intervention period.

• Sociodemographic Factors

  Baseline and Month 6 (end of intervention).

Study Arms (1)

Multi-Modal Transitional Care Intervention

EXPERIMENTAL

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.

Behavioral: Group-Based Psychoeducation; Behavioral: Peer Support; Behavioral: Personalized Support for Community Healthcare Provider

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.

Multi-Modal Transitional Care Intervention

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.

Multi-Modal Transitional Care Intervention

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.

Multi-Modal Transitional Care Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: collaborator
• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

RECRUITING

Related Publications (5)

• Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppes T, Calabrese JR, Vieta E, Malhi G, Post RM, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018 Mar;20(2):97-170. doi: 10.1111/bdi.12609. Epub 2018 Mar 14.

  PMID: 29536616 BACKGROUND

• Gomes FA, Dumay H, Fagen J, Palma N, Milev R, Brietzke E. Does the Ranking Matter? A Retrospective Cohort Study Investigating the Impact of the 2018 CANMAT and ISBD Guidelines for the Management of Patients with Bipolar Disorder Treatment Recommendations for Acute Mania on Rehospitalization Rates. Can J Psychiatry. 2023 Aug;68(8):605-612. doi: 10.1177/07067437231156235. Epub 2023 Feb 21.

  PMID: 37551100 BACKGROUND

• Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.

  PMID: 29800949 BACKGROUND

• Simjanoski M, de Azevedo Cardoso T, Frey BN, Minuzzi L, De Boni RB, Balanza-Martinez V, Kapczinski F. Lifestyle in bipolar disorder: A cross-sectional study. Span J Psychiatry Ment Health. 2023 Oct-Dec;16(4):244-250. doi: 10.1016/j.rpsm.2023.04.001. Epub 2023 May 26.

  PMID: 37839960 BACKGROUND

• Ratheesh A, Hett D, Ramain J, Wong E, Berk L, Conus P, Fristad MA, Goldstein T, Hillegers M, Jauhar S, Kessing LV, Miklowitz DJ, Murray G, Scott J, Tohen M, Yatham LN, Young AH, Berk M, Marwaha S. A systematic review of interventions in the early course of bipolar disorder I or II: a report of the International Society for Bipolar Disorders Taskforce on early intervention. Int J Bipolar Disord. 2023 Jan 3;11(1):1. doi: 10.1186/s40345-022-00275-3.

  PMID: 36595095 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Fabiano A. Gomes, MD, Ph.D.

CONTACT

905-522-1155; gomesfs@mcmaster.ca

Daniela Giansante, MSc

CONTACT

giansand@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)