A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

NCT04020289 | Completed DMC

• 1 other identifier: NCKU
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; depression; manic; illness perception

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

"BalancingMySwing"

EXPERIMENTAL

Psychoeducational Program "BalancingMySwing" for bipolar disorder

Behavioral: Psychoeducational Program "BalancingMySwing"

treatment as usual (TAU)

OTHER

Patients received treatment as usual

Behavioral: Psychoeducational Program "BalancingMySwing"

Interventions

Psychoeducational Program "BalancingMySwing" BEHAVIORAL

Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy

"BalancingMySwing"; treatment as usual (TAU)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esther C Lin

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Treatment as usual (TAU); and Psychoeducational Program "BalancingMySwing"

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 16, 2019
• Study Start: August 1, 2015
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.