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A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

Primary Purpose

Bipolar Disorder Family Members

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation
Psychoeducation - Delayed
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder Family Members

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Health Science Center at Houston School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Wait List Control Group

Arm Description

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.

Subjects in the wait list control group will receive the same 7 psychoeducation sessions after the experimental group receives these sessions.

Outcomes

Primary Outcome Measures

Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks

Secondary Outcome Measures

Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks
Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks
Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks
Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks

Full Information

First Posted
April 23, 2015
Last Updated
November 2, 2020
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02446509
Brief Title
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder
Official Title
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder Family Members

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
Active Comparator
Arm Description
Subjects in the wait list control group will receive the same 7 psychoeducation sessions after the experimental group receives these sessions.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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
Intervention Name(s)
Psychoeducation - Delayed
Intervention Description
The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.
Primary Outcome Measure Information:
Title
Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks
Time Frame
Baseline, 16 weeks
Title
Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks
Time Frame
Baseline, 8 weeks
Title
Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks
Time Frame
Baseline, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas Health Science Center at Houston School of Nursing
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States

12. IPD Sharing Statement

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A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

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