- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446509
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder: A Feasibility Study
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:
- 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.
- Explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.
The intervention will be delivered by at the University of Texas Health Science Center at Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health Science Center at Houston School of Nursing. Forty family caregivers of patients with bipolar disorder will be recruited into the study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77070
- University of Texas Health Science Center at Houston School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary family caregiver of a patient with Bipolar Disorder who is age 16 or older;
- live within a 70 mile radius of the Center for Excellence in Mood Disorders (in the Texas Medical Center)
Exclusion Criteria:
- unstable major medical illness;
- health condition that may impact biomarker levels, e.g. is taking corticosteroids or anti-inflammatory drugs;
- unable to read, write, or speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
The experimental group will receive a 7-week group psychoeducation intervention.
Caregivers will meet once a week for 90-minute sessions in a group setting.
Dates and times of the group sessions will be arranged according to the convenience of the subjects.
The major content will include the causes of bipolar disorder, signs and symptoms of bipolar disorder, the role of stress and life events, types of medications and what they do, self-management of the disorder, understanding the course of the disorder, genetic and biological predispositions, how the family can help, management of relapse.
|
Caregivers will meet once a week for 90-minute sessions in a group setting.
Dates and times of the group sessions will be arranged according to the convenience of the subjects.
The major content will include the causes of bipolar disorder, signs and symptoms of bipolar disorder, the role of stress and life events, types of medications and what they do, self-management of the disorder, understanding the course of the disorder, genetic and biological predispositions, how the family can help, management of relapse.
|
Active Comparator: Wait List Control Group
Subjects in the wait list control group will receive the same 7 psychoeducation sessions after the experimental group receives these sessions.
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The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
Time Frame: Baseline, 8 weeks
|
Baseline, 8 weeks
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Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks
Time Frame: Baseline, 16 weeks
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Baseline, 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks
Time Frame: Baseline, 8 weeks
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Baseline, 8 weeks
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Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks
Time Frame: Baseline, 16 weeks
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Baseline, 16 weeks
|
Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks
Time Frame: Baseline, 8 weeks
|
Baseline, 8 weeks
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Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks
Time Frame: Baseline, 16 weeks
|
Baseline, 16 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SN-13-0579
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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