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A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

NCT ID: NCT02446509

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-11-30

Brief Summary

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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 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.

Detailed Description

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Conditions

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Bipolar Disorder Family Members

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation - Delayed

Intervention Type BEHAVIORAL

The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.

Interventions

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Psychoeducation

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.

Intervention Type BEHAVIORAL

Psychoeducation - Delayed

The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Lynn Casarez

Associate Professor - Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Health Science Center at Houston School of Nursing

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-SN-13-0579

Identifier Type: -

Identifier Source: org_study_id