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A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder

2019年7月16日 更新者：Esther Ching-Lan Lin、National Cheng Kung University

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的："BalancingMySwing"
Psychoeducational Program "BalancingMySwing" for bipolar disorder
行为的：Psychoeducational Program "BalancingMySwing"
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
其他：treatment as usual (TAU)
Patients received treatment as usual
行为的：Psychoeducational Program "BalancingMySwing"
Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes from Baseline Social Rhythm through Study Completion, at the 3rd and the 6th month after study completion
大体时间：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.
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
大体时间：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.
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
大体时间：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.
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
大体时间：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.
At baseline; through study completion, an average of 2 months; at the 3rd and the 6th month after study completion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cheng Kung University

调查人员

  • 首席研究员：Esther C Lin、National Cheng Kung University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年8月1日

初级完成 (实际的)

2018年7月31日

研究完成 (实际的)

2018年12月31日

研究注册日期

首次提交

2019年7月8日

首先提交符合 QC 标准的

2019年7月11日

首次发布 (实际的)

2019年7月16日

研究记录更新

最后更新发布 (实际的)

2019年7月17日

上次提交的符合 QC 标准的更新

2019年7月16日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NCKU

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

We plan to use only for data analysis and publication without any recognized individual identification.

IPD 共享时间框架

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 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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