Bipolar DisorderNCT02893007
A Brief Family-centered Care Program for Bipolar Disorder
A study testing Brief family-centered care (BFCC) program in people with Bipolar Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Brief family-centered care (BFCC) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Brief family-centered care (BFCC) program
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief family-centered care (BFCC) programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief family-centered care program | Experimental | 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. Receives: Other: Brief family-centered care (BFCC) program |
| treatment-as-usual (TAU) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: To assess the change from baseline through study completion, an average of 4 weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: All were assessed the change from baseline through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Hsiu-Ju Lee, MS, Principal investigator, Head Nurse, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893007
- Sponsor's protocol ID
- 201002004IA
- Status last verified
- Sep 2016
- First submitted
- 28 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Brief Family-centered Care Program for Hospitalized Patients With Bipolar Disorder and Their Caregivers
- ClinicalTrials.gov ID
- NCT02893007
- Acronym / sponsor ID
- 201002004IA
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief family-centered care program | Experimental | Other: Brief family-centered care (BFCC) programThe 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. |
| treatment-as-usual (TAU) | No intervention | –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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief family-centered care (BFCC) programThe 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. | Other | Brief family-centered care program |
Primary outcome
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.
2 secondary outcomes
Change of caregivers' perceived health status assessed by the Chinese Health Questionnaire (CHQ)-12
Time frame: 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)
Time frame: All were assessed the change from baseline through study completion, an average of 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Not yet recruitingObservational study
Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders
Major Depressive Disorder, Bipolar Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Ju Lee, MS principal investigator
Head Nurse, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief family-centered care (BFCC) program in people with Bipolar Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.