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A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT02446509
Recruitment Status : Terminated
First Posted : May 18, 2015
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecca Lynn Casarez, The University of Texas Health Science Center, Houston

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. 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.


Condition or disease Intervention/treatment Phase
Bipolar Disorder Family Members Behavioral: Psychoeducation Behavioral: Psychoeducation - Delayed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder: A Feasibility Study
Study Start Date : September 2013
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.

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.
Behavioral: Psychoeducation - Delayed
The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.




Primary Outcome Measures :
  1. Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  2. Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks [ Time Frame: Baseline, 16 weeks ]

Secondary Outcome Measures :
  1. Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  2. Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks [ Time Frame: Baseline, 16 weeks ]
  3. Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  4. Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks [ Time Frame: Baseline, 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446509


Locations
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United States, Texas
University of Texas Health Science Center at Houston School of Nursing
Houston, Texas, United States, 77070
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Responsible Party: Rebecca Lynn Casarez, Associate Professor - Clinical, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02446509    
Other Study ID Numbers: HSC-SN-13-0579
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders