Clinical trial NCT02893007: A Brief Family-centered Care Program for Bipolar Disorder
Official title: A Randomized Controlled Trial of a Brief Family-centered Care Program for Hospitalized Patients With Bipolar Disorder and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-09-08
Enrollment: 47
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of family function assessed by the Chinese-version Family Functioning Scale (FFS)
timeFrame: To assess the change from baseline through study completion, an average of 4 weeks.
Secondary outcomes:
measure: Change of caregivers' perceived health status assessed by the Chinese Health Questionnaire (CHQ)-12
timeFrame: All were assessed the change from baseline through study completion, an average of 4 weeks.
measure: Change of caregivers' burden assessed by the the Chinese-version Caregiver Burden Inventory (CBI)
timeFrame: All were assessed the change from baseline through study completion, an average of 4 weeks.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Head Nurse, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
name: Hsiu-Ju Lee, MS
role: PRINCIPAL_INVESTIGATOR
References: