A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020289
• Other study ID #: NCKU
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Psychoeducational Program "BalancingMySwing"
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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