A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder
NCT02446509 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-11-03
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.
Conditions
- Bipolar Disorder Family Members
Interventions
- 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.
- BEHAVIORAL
-
Psychoeducation - Delayed
The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.
Sponsors & Collaborators
-
The University of Texas Health Science Center, Houston
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2019-11-30
- Completion
- 2019-11-30
Countries
- United States
Study Locations
More Related Trials
-
A Brief Family-centered Care Program for Bipolar Disorder
NCT02893007 ·Status: COMPLETED ·Phase: NA
-
Functional Remediation for Bipolar Disorder
NCT03403179 ·Status: COMPLETED ·Phase: NA
-
Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial
NCT06176001 ·Status: COMPLETED ·Phase: NA
-
Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder
NCT07213492 ·Status: RECRUITING ·Phase: NA
-
Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
NCT00943085 ·Status: COMPLETED ·Phase: NA
-
Study of the Effectiveness of Specific Training of Health Professionals on Adherence in Bipolar Disorder
NCT02904083 ·Status: UNKNOWN ·Phase: NA
-
Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
NCT02506322 ·Status: COMPLETED ·Phase: NA
-
Effect of Dialectical Behavior in Patients With Bipolar Disorder
NCT05741268 ·Status: COMPLETED ·Phase: NA
-
Early Intervention for Youth at Risk for Bipolar Disorder
NCT01483391 ·Status: COMPLETED ·Phase: NA
-
The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
NCT02241863 ·Status: COMPLETED ·Phase: NA
-
Early Assessment and Intervention for Adolescents at Risk for Bipolar Disorder
NCT03203707 ·Status: COMPLETED ·Phase: NA
-
"Mindfulness vs Psychoeducation in Bipolar Disorder"
NCT02133170 ·Status: UNKNOWN ·Phase: NA
-
Effects of Psycho-education of Patients With Bipolar Disorder
NCT00159562 ·Status: COMPLETED ·Phase: NA
-
Acceptance and Commitment Therapy Based Psychoeducation, Meaning of Life and Coping Skills in Bipolar Disorder
NCT06131866 ·Status: COMPLETED ·Phase: NA
-
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder
NCT01176825 ·Status: COMPLETED ·Phase: PHASE1
-
Parents With Bipolar Disorder: Relationship of Adaptation to Own Illness With Risk Perception and Coping With Perceived Risk to a Child
NCT01012180 ·Status: COMPLETED
-
A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
NCT04020289 ·Status: COMPLETED ·Phase: NA
-
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
NCT00746343 ·Status: COMPLETED ·Phase: NA
-
Early Detection and Prevention of Mood Disorders in Children of Parents With Bipolar Disorder
NCT00338806 ·Status: COMPLETED ·Phase: NA
-
Understanding Treatment Adherence Among Individuals With Bipolar Disorder
NCT00183495 ·Status: COMPLETED
-
Early Intervention for Youth at High Risk for Bipolar Disorder
NCT04815239 ·Status: RECRUITING ·Phase: NA
-
Improving Care for Patients With Bipolar Disorder
NCT00222755 ·Status: COMPLETED ·Phase: NA
-
Reasoning Training in Individuals With Bipolar Disorder
NCT02843282 ·Status: COMPLETED ·Phase: NA
-
Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
NCT00188838 ·Status: UNKNOWN ·Phase: NA
-
Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial
NCT02637401 ·Status: COMPLETED