A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducational Program "BalancingMySwing"
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, depression, manic, illness perception
Eligibility Criteria
Inclusion Criteria:
- Had a DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-IV) diagnosis of BP-I or II confirmed through the interviews using the Chinese version of the Modified Schedule of Affective Disorder and Schizophrenia-Lifetime.
- Able to speak and read Taiwanese or Taiwanese Mandarin Chinese
- Had signed a written consent form
- Agreed to accept the following medication therapy during the study: a mood stabilizer (valproic acid or lithium salts), an antidepressant, second generation antipsychotics, anxiolytics (lorazepam [< 8 mg/day]), and medicine to counteract side effects: extrapyramidal symptoms, tachycardia, and involuntary movement of smooth muscles in the gastrointestinal tract, urinary tract, lungs, etc.
Exclusion Criteria:
- Required immediate hospitalization
- Had any comorbidity with substance abuse or were current alcohol or drug abusers, or had been in the previous year
- Had been diagnosed with an organic psychosis, a neurodegenerative disease, a personality disorder, or impaired cognitive abilities
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
"BalancingMySwing"
treatment as usual (TAU)
Arm Description
Psychoeducational Program "BalancingMySwing" for bipolar disorder
Patients received treatment as usual
Outcomes
Primary Outcome Measures
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Social Rhythm Metric-5 items (SRM-5)-- The total scores range from 0 to 5; the higher the score the more regularly the activities occur.
Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
Illness Perception Questionnaire-Revised (IPQ-R) has 3 subscales. The first subscale (identity) determines whether patients attribute specific symptoms to BD (total score: range = 0-10). The second subscale assesses 25 items of illness perceptions. The third subscale assessed the causes of BD. The second and third subscales are rated on a 5-point Likert scale (range: 1~5). A higher score on each item indicates a stronger belief in that illness perception.
Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
Young Mania Rating Scale (YMRS)--The total score of the 11-item YMRS is the summation of the 2 subscales (range: 0-60), and could be divided into four levels: 0 to 12 means remission, 13 to 19 means minimal severe, > 20 as diagnosed with mania based on DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, IV) criteria, and over 25 showed obvious symptoms.
Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
Hamilton Depression Rating Scale (HDRS)--The total score of the 17-item HDRS is the summation of the 2 subscales(ranged: 0- 52), and could be divided into four levels: 0-7 means remission, 8-13 means mild severe, 14-22 means moderate severe, and > 23 means very severe.
Secondary Outcome Measures
Full Information
NCT ID
NCT04020289
First Posted
July 8, 2019
Last Updated
July 16, 2019
Sponsor
National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT04020289
Brief Title
A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
Official Title
A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for BD, and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.
Detailed Description
The psychoeducation BalancingMySwing (BMS) program has been developed manually and its feasibility has been tested in our previous study. This 3-year research project aimed to further examine the immediate and lasted effects of BMS program for bipolar disorders (BD), and to assess its knowledge dissemination and the transferability of its evidence-based practice across multiple sites.
During the first 2 years, a randomized controlled trial was conducted. Patients diagnosed with BD were recruited and 104 patients were randomly assigned to treatment as usual (TAU) or to 8 BMS sessions. A battery of three outcome indicators-social rhythm, illness perception, and symptom severity-were used to examine the effects of the two groups at baseline, after intervention, and every 3 months until half year. In addition, a pre- and post-test quasi-experimental study combined with qualitative design was used to assess the translational feasibility of BMS and to explore related barriers and facilitators of implementing BMS in clinical settings in the third year. Nurses from 4 Hospitals received the BMS training, and patients with BD received the BMS translated in practice were recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, depression, manic, illness perception
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment as usual (TAU); and Psychoeducational Program "BalancingMySwing"
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"BalancingMySwing"
Arm Type
Experimental
Arm Description
Psychoeducational Program "BalancingMySwing" for bipolar disorder
Arm Title
treatment as usual (TAU)
Arm Type
Other
Arm Description
Patients received treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Program "BalancingMySwing"
Intervention Description
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
Primary Outcome Measure Information:
Title
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
Description
Social Rhythm Metric-5 items (SRM-5)-- The total scores range from 0 to 5; the higher the score the more regularly the activities occur.
Time Frame
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Title
Changes from Baseline Illness Perception through Study Completion, at the 3rd and the 6th month after study completion
Description
Illness Perception Questionnaire-Revised (IPQ-R) has 3 subscales. The first subscale (identity) determines whether patients attribute specific symptoms to BD (total score: range = 0-10). The second subscale assesses 25 items of illness perceptions. The third subscale assessed the causes of BD. The second and third subscales are rated on a 5-point Likert scale (range: 1~5). A higher score on each item indicates a stronger belief in that illness perception.
Time Frame
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Title
Changes from Baseline Manic Symptom through Study Completion, at the 3rd and the 6th month after study completion
Description
Young Mania Rating Scale (YMRS)--The total score of the 11-item YMRS is the summation of the 2 subscales (range: 0-60), and could be divided into four levels: 0 to 12 means remission, 13 to 19 means minimal severe, > 20 as diagnosed with mania based on DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, IV) criteria, and over 25 showed obvious symptoms.
Time Frame
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
Title
Changes from Baseline Depressive Symptom through Study Completion, at the 3rd and the 6th month after study completion
Description
Hamilton Depression Rating Scale (HDRS)--The total score of the 17-item HDRS is the summation of the 2 subscales(ranged: 0- 52), and could be divided into four levels: 0-7 means remission, 8-13 means mild severe, 14-22 means moderate severe, and > 23 means very severe.
Time Frame
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had a DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-IV) diagnosis of BP-I or II confirmed through the interviews using the Chinese version of the Modified Schedule of Affective Disorder and Schizophrenia-Lifetime.
Able to speak and read Taiwanese or Taiwanese Mandarin Chinese
Had signed a written consent form
Agreed to accept the following medication therapy during the study: a mood stabilizer (valproic acid or lithium salts), an antidepressant, second generation antipsychotics, anxiolytics (lorazepam [< 8 mg/day]), and medicine to counteract side effects: extrapyramidal symptoms, tachycardia, and involuntary movement of smooth muscles in the gastrointestinal tract, urinary tract, lungs, etc.
Exclusion Criteria:
Required immediate hospitalization
Had any comorbidity with substance abuse or were current alcohol or drug abusers, or had been in the previous year
Had been diagnosed with an organic psychosis, a neurodegenerative disease, a personality disorder, or impaired cognitive abilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther C Lin
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to use only for data analysis and publication without any recognized individual identification.
IPD Sharing Time Frame
Data analysis and publication will have occur at the end of the study, and continue after 7 months of the summary data are published.
IPD Sharing Access Criteria
Only the research members in out research team can access individual participant data (IPD) and any additional supporting information and only for statistic data analysis and publication under the PI supervision. The PI will review all information shared to follow the research purpose.
Learn more about this trial
A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
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