A Randomized Controlled Trial of a Psychoeducational Program"BalancingMySwing" for Patients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
"BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
干预措施: Psychoeducational Program "BalancingMySwing" (Behavioral)
treatment as usual (TAU)
Patients received treatment as usual
干预措施: Psychoeducational Program "BalancingMySwing" (Behavioral)
结局指标
主要结局
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
时间窗: At baseline; through study completion, an average of 2 months; 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
时间窗: At baseline; through study completion, an average of 2 months; 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
时间窗: At baseline; through study completion, an average of 2 months; 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
时间窗: At baseline; through study completion, an average of 2 months; 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.
次要结局
未报告次要终点
研究者
Esther Ching-Lan Lin
Associate Professor
National Cheng Kung University