A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: Psychoeducational Program "BalancingMySwing"

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "BalancingMySwing"; Psychoeducational Program "BalancingMySwing" for bipolar disorder	Behavioral: Psychoeducational Program "BalancingMySwing"; Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
Other: treatment as usual (TAU); Patients received treatment as usual	Behavioral: Psychoeducational Program "BalancingMySwing"; Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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.	At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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.	At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion
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.	At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Investigators: Principal Investigator: Esther C Lin, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: depression; bipolar disorder; illness perception; manic
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: NCKU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No