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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
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, depression, manic, illness perception

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 8, 2019
    Last Updated
    July 16, 2019
    Sponsor
    National Cheng Kung University
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    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.

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    A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

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