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Clinical Trials/NCT02893007
NCT02893007
Completed
N/A

A Randomized Controlled Trial of a Brief Family-centered Care Program for Hospitalized Patients With Bipolar Disorder and Their Caregivers

Taipei Veterans General Hospital, Taiwan1 site in 1 country47 target enrollmentMarch 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bipolar Disorder
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
47
Locations
1
Primary Endpoint
Change of family function assessed by the Chinese-version Family Functioning Scale (FFS)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Family interventions have been emphasized in the treatment of BPD and have benefits for patients' symptoms and health; however, the effects of family interventions on family function and caregivers' health-related outcomes have not been well investigated. This randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC) program with treatment-as-usual (TAU). The findings support both the feasibility of using the BFCC program for inpatients and its specific benefits for family function. An intensive family intervention during hospitalization has been suggested in psychiatric practice to support patients with BPD and family caregivers.

Detailed Description

All of the family caregivers in two groups were invited to attend a routine 60-minute family discussion group about violence and suicide prevention. The TAU group without specific family interview for patient and family caregiver dyad. In the BFCC group, four 90-minute BFCC program sessions were additionally provided twice a week for each hospitalized family dyad. It was hypothesized that family caregivers in the BFCC group could primary increase their family function, and secondary improve perceived health status and reduce caregiver's burdens compared to the TAU. The results showed family caregivers in the BFCC group significant time group interaction effects in overall family function (p=0.03) and subscale-conflict (p=0.04), communication (p=0.01), and problem solving (p=0.04), but there were no significant interaction effects on the caregivers' perceived health status and caregiver's burdens.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
December 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

vghtpe user

Head Nurse

Taipei Veterans General Hospital, Taiwan

Eligibility Criteria

Inclusion Criteria

  • Patients were enrolled if they met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (American Psychiatric Association 1994) criteria for BP-I or BP-II disorder, were able to be interviewed, and had a Hamilton Depression Rating Scale (HDRS) score \< 17 and a Young Mania Rating Scale (YMRS) score \< 38 (Keck 2004) to prevent adverse effects caused by patients' mood instability.
  • Family caregivers who were identified as: (i) significant in the patient's life, (ii) at least 18 years old, (iii) having lived with the patient for at least 6 months, (iv) able to speak and understand Chinese or Taiwanese, and (v) able to answer questionnaires written in Chinese were included.

Exclusion Criteria

  • Patients who had lived alone or lived with their family for less than 6 months, had been concurrently diagnosed with intellectual disability (DSM-5) (American Psychiatric Association 2013), had been newly diagnosed with BPD at this admission, or could not speak Chinese were excluded.
  • Caregivers diagnosed with a serious mental illness or intellectual disabilities were excluded.

Outcomes

Primary Outcomes

Change of family function assessed by the Chinese-version Family Functioning Scale (FFS)

Time Frame: To assess the change from baseline through study completion, an average of 4 weeks.

Self-reported, each item is rated using a 5-point Likert scale, and 11 negative items are reverse-scored. Higher scores indicate better family function.

Secondary Outcomes

  • Change of caregivers' perceived health status assessed by the Chinese Health Questionnaire (CHQ)-12(All were assessed the change from baseline through study completion, an average of 4 weeks.)
  • Change of caregivers' burden assessed by the the Chinese-version Caregiver Burden Inventory (CBI)(All were assessed the change from baseline through study completion, an average of 4 weeks.)

Study Sites (1)

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