Back to resultsA Brief Family-centered Care Program for Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Brief family-centered care (BFCC) program
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
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.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief family-centered care program
treatment-as-usual (TAU)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02893007
First Posted
August 28, 2016
Last Updated
September 11, 2016
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02893007
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief family-centered care program
Arm Type
Experimental
Arm Description
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.
Arm Title
treatment-as-usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Brief family-centered care (BFCC) program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of family function assessed by the Chinese-version Family Functioning Scale (FFS)
Description
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.
Time Frame
To assess the change from baseline through study completion, an average of 4 weeks.
Secondary Outcome Measure Information:
Title
Change of caregivers' perceived health status assessed by the Chinese Health Questionnaire (CHQ)-12
Description
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.
Time Frame
All were assessed the change from baseline through study completion, an average of 4 weeks.
Title
Change of caregivers' burden assessed by the the Chinese-version Caregiver Burden Inventory (CBI)
Description
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.
Time Frame
All were assessed the change from baseline through study completion, an average of 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Ju Lee, MS
Organizational Affiliation
Head Nurse, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Brief Family-centered Care Program for Bipolar Disorder
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