A Brief Family-centered Care Program for Bipolar Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Brief family-centered care (BFCC) program

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brief family-centered care program; The Brief family-centered care (BFCC) program was developed and provided for hospitalized patients with BPD and their family caregivers.The BFCC protocol is outlined as 4 treatment sessions, specific goals, and example questions. Four 90-minute in-depth sessions for each dyad were initially held in a quiet interview room to assess family function, then to provide information about BPD, to support and empower the dyads to change communication styles and resolve conflicts, and to sustain or improve family function in the cognitive, affective, and behavioral domains.	Other: Brief family-centered care (BFCC) program; The therapist provided the 4-session BFCC program twice a week for each dyad. The core principles treated family as a single unit and provided individually tailored interventions to improve family function through psychoeducation, social and emotional support, and actively raising questions to facilitate constructive awareness and changes. It was initially held to assess family function, then to provide information about BPD, to support and empower the dyads to change communication styles and resolve conflicts, and to sustain or improve family function in the cognitive, affective, and behavioral domains.
NO_INTERVENTION: treatment-as-usual (TAU); All patients were given the standard hospital-provided services: psychiatric nursing care, occupational therapy, and pharmacotherapy. All of the family caregivers were only to attend a routine 60-minute family discussion group about violence and suicide prevention without any specific patient-family dyad interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of family function assessed by the Chinese-version Family Functioning Scale (FFS)	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.	To assess the change from baseline through study completion, an average of 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of caregivers' perceived health status assessed by the Chinese Health Questionnaire (CHQ)-12	It contains 12 items in four dimensions: physiological and somatic, anxiety and worry, depression and poor relationships, and sleep problems. Each item is rated using a 4-point Likert scale (0-3). Total scores < 3 indicated normal psychological health, and total scores > 3 indicated worsening symptoms and that the patient was at risk for mental problems. Higher scores indicated worsening conditions.	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)	The CBI contains 24 items in 5 dimensions: physiological, social, emotional, time, and development. Each item is rated using a 5-point Likert scale (0-4); total scores range from 0 to 96. Higher scores mean greater caregiver burdens.	All were assessed the change from baseline through study completion, an average of 4 weeks.

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Hsiu-Ju Lee, MS, Head Nurse, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: August 28, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (ESTIMATE): September 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 11, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 201002004IA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO