A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder
Other study identifiers
Sponsor study identifier
interventional
12
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2019
Actual (reported)Study Completion
November 2019
Actual (reported)Brief Summary
Bipolar disorder is a debilitating chronic illness characterized by periods of elation and depression. Since deinstitutionalization of the mentally ill over 40 years ago, families have become major caregivers for patients with bipolar disorder . This illness imposes a substantial and chronic burden on family caregivers Despite their persistent stress and burden, these caregivers have been largely ignored. Interventions to help them have been very limited. One comprehensive intervention was developed and implemented by Miklowitz (2008) and has shown to be effective in reducing caregiver depression and improving health outcomes. However, this intervention and is highly complex, long, and was given on an individual basis, significantly raising the cost of the program. One core component of the Miklowitz (2008) intervention is psychoeducation, which provides the fundamental support and information needed to caregivers on an individual basis. In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions. After completion of these sessions in the intervention group, the wait list control group will receive the same weekly sessions. In this study, the investigators plan to test the feasibility and potential efficacy of this specific psychoeducation intervention implemented in a group setting. The investigators will also examine the effects of this psychosocial intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health outcomes. The specific aims are to:
- 1.Test the feasibility of implementing a 7-week group psychoeducation program for family caregivers of patients with bipolar disorder by assessing recruitment and retention rates, attendance, satisfaction with the program, and data and sample collection rate.
- 2.Explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- terminated
- Actual enrollment (reported)
- 12 participants
- Study completion date
November 2019
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
April 23, 2015
Actual (reported)First Posted
May 18, 2015
Actual (reported)Primary Completion
November 2019
Actual (reported)Study Completion
November 2019
Actual (reported)
- Last Updated
- November 3, 2020
- Status Verified
- November 2020
- Last Update Submitted
- November 2, 2020