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NCT02446509 · ClinicalTrials.gov registry record · NA
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT02446509 is a NA study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 12 participants.
The verdict
NCT02446509, a NA study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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. The intervention will be delivered by at t
Interventions
- BEHAVIORAL Psychoeducation
- BEHAVIORAL Psychoeducation - Delayed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-09 |
| Est. Completion | 2019-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02446509
The ClinicalTrials.gov registry entry for NCT02446509 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psychoeducation is the first listed.
NCT02446509 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02446509 about?
NCT02446509 is a clinical study titled "A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder". 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 ...
What is the current status of trial NCT02446509?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2013-09. Estimated completion is 2019-11.
What interventions are being tested in trial NCT02446509?
The interventions under investigation include: Psychoeducation (BEHAVIORAL), Psychoeducation - Delayed (BEHAVIORAL).
Who is sponsoring clinical trial NCT02446509?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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