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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
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.
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.
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.
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
RECRUITINGFeasibility 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.
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).
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).
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).
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).
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).
Change in Insight (MDIS)
Self-report scale assessing insight in mood disorders. Participants respond "Agree," "Disagree," or "Unsure." Higher scores indicate better insight.
Time frame: Baseline and Month 6 (end of intervention).
Change in Psychosocial Functioning (FAST)
Clinician-administered scale assessing functioning across six domains (autonomy, work, cognition, finances, relationships, leisure). Each item rated 0-3.
Time frame: Baseline and Month 6 (end of intervention).
Change in Cognitive Complaints (COBRA)
16-item self-report questionnaire measuring cognitive dysfunction in bipolar disorder. Each item scored 0-3; higher scores indicate more impairment.
Time frame: Baseline and Month 6 (end of intervention).
Change in Quality of Life (Q-LES-Q-SF)
16-item self-report scale assessing satisfaction and enjoyment in multiple life areas over the past week. Items rated on a 5-point scale.
Time frame: Baseline, Mid-intervention (Month 3), and Month 6 (end of intervention).
Change in Lifestyle Behaviours (SMILE)
Self-report scale measuring behaviours across seven lifestyle domains (diet and nutrition, substance use, physical activity, stress management, restorative sleep, social support, and environmental exposures). Items scored on a 4-point scale; higher scores reflect healthier lifestyle.
Time frame: Baseline and Month 6 (end of intervention).
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