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

Official title

A Bridge to Better Days: A Pilot Study of a Multimodal Intervention to Support the Successful Transition From Hospital to Community Care for People Living With Bipolar Disorder

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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.
• 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.
• 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.

Primary outcome measures

• 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).]

Secondary outcome measures (9)

• Change in Depression Symptoms (MADRS) [Time frame: Baseline and Month 6 (end of intervention).]
• Change in Mania Symptoms (YMRS) [Time frame: Baseline and Month 6 (end of intervention).]
• Change in Anxiety Symptoms (GAD-7) [Time frame: Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).]
• Change in Depression Severity (Patient Health Questionnaire) (PHQ-9) [Time frame: Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).]
• Change in Insight (MDIS) [Time frame: Baseline and Month 6 (end of intervention).]
• Change in Psychosocial Functioning (FAST) [Time frame: Baseline and Month 6 (end of intervention).]
• Change in Cognitive Complaints (COBRA) [Time frame: Baseline and Month 6 (end of intervention).]
• Change in Quality of Life (Q-LES-Q-SF) [Time frame: Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).]
• Change in Lifestyle Behaviours (SMILE) [Time frame: Baseline and Month 6 (end of intervention).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• St. Joseph's Healthcare Hamilton — Hamilton

Publications

• 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 Bip PMID 29536616
• 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
• 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 Revie PMID 29800949
• 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
• 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. 20 PMID 36595095

Identifiers

NCT: NCT07213492 · 18669

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗