A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

NCT02446509 | Terminated

• 1 other identifier: HSC-SN-13-0579
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 2.Explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.

Conditions

Bipolar Disorder Family Members

Outcome Measures

Primary Outcomes (2)

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

  Baseline, 8 weeks

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

  Baseline, 16 weeks

Secondary Outcomes (4)

• Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks

  Baseline, 8 weeks

• Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks

  Baseline, 16 weeks

• Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks

  Baseline, 8 weeks

• Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks

  Baseline, 16 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Psychoeducation

Wait List Control Group

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation - Delayed

Interventions

Psychoeducation 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.

Experimental Group

Psychoeducation - Delayed BEHAVIORAL

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

Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston School of Nursing

Houston, Texas, 77070, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Clinical

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 18, 2015
• Study Start: September 1, 2013
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

US (1)