Clinical trial NCT02446509: 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
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder Family Members
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Caregiver Burden as measured by the Burden Assessment Scale at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in Caregiver Burden as measured by the Burden Assessment Scale at 16 weeks
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in Caregiver Mental Well Being as measured by the Warwick-Edinburgh Mental Well-Being Scale at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change in Caregiver Depression as measured by the Quick Inventory of Depressive Symptomatology Clinician-Rated at 16 weeks
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston School of Nursing
state: Texas
Study officials:
References: