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临床试验/NCT01152034
NCT01152034已完成不适用

Effect of Psychoeducational Group Therapy Model for Bipolar Disorder Patients

Mackay Memorial Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
The main outcome measures are time to recurrence a new acute bipolar episode

研究概览

简要总结

This study aims to develop the MAPS(M,Monitoring;A,Assessing;P,Preventing or Reducing Relapse;S,Smart goal setting) group therapy model for bipolar disorder patients as other adjuvant clinical treatment and develop the instruments for evaluating the severity of bipolar symptoms. The investigators insist to provide the psychosocial intervention for bipolar patients in the general hospital and offer appropriative adjuvant intervention except current psychiatric biological treatment.

This study is a one-year project. First, the investigators like to translate the Depression, Anxiety and Stress Scale (DASS) and the Altman Self-Rating Scale for Mania (ASRM) to Chinese and finish the reliability and validity study. Second, the investigators would like to develop the MAPS group therapy to enhance bipolar patients' insight, increased life quality and decrease suicidal ideation. This study is a case control study. All cases recruit from the psychiatric outpatient department of one medical center. The inclusion criteria are diagnosed as bipolar disorder, age from 18 to 65 and agree to sign the inform consent. The excluded criteria are hard to communicate, with acute psychiatric feature and severe physical illness. The investigators plan to hold the MAPS group three times and predetermine to recruit totally 30 patients as the case group. As to the control group, the investigators also recruit from the psychiatric outpatient department and those who treat as usual by control their gender, age and the same diagnosis as bipolar disorder. The only one different factor between the case group and the control group was attending the MAPS group therapy or not. In MAPS group therapy, two facilitators work with ten clients with twelve weekly sessions and three monthly booster sessions. Self-report rating scales (DASS and ASRM) are completed at the beginning of each session. The investigators use DASS and ASRM to evaluate the severity of bipolar symptoms; BSS for suicidal ideation; SF-36 for life quality. The hypothesis is "patients attended to MAPS group therapy have better symptoms control, lower suicidal ideation, better life quality and less use emergency department or admissions than those who didn't attend the group therapy".

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • bipolar disorder outpatients in remission, defined as Young Mania Rating Scale score < 6, Hamiltone Depression Rating Scale-17 < 8
  • age 18 to 65 years old
  • speaking Mandarin
  • agree to sign the inform consent

排除标准

  • Those who were hard to communicate such as mental retardation, hearing impairment and etc
  • with acute psychotic feature
  • with severe physical illness

研究组 & 干预措施

Psychoeducation group therapy

Experimental

The structured group program comprised of an initial block of 12 weekly sessions with three additional monthly booster sessions, designed to support participants in the application of knowledge and skills to everyday life situations. All participants also received standard psychiatric care as well.

干预措施: psychoeducation group therapy (Behavioral)

Treat as Usual

Placebo Comparator

Patients who were assigned to the control group received standard psychiatric care and standard pharmacological treatment without group-based psychosocial intervention. Weekly phone calls to the control group over the initial 12 weeks were controlled for any extra contact time with researchers outside of the structured intervention group.

结局指标

主要结局

The main outcome measures are time to recurrence a new acute bipolar episode

时间窗: every 3 months for up to 12 months after enrollment

This is defined as the time (days) elapsed between baseline and the emergence of a new acute episode according to DSM-IV criteria and scores above or equal to 20 on the YMRS for manic recurrence; above or equal to 12 for hypomanic recurrence; above or equal to 17 on the HRSD-17 for depressive recurrence; and above or equal to 20 on the YMRS and 12 on the HRSD-17 for mixed recurrence.

次要结局

  • Number of recurrences(every 3 months for up to 12 months after enrollment)
  • Time spent ill(every 3 months for up to 12 months after enrollment)
  • Psychiatric outpatient adherence and drug compliance(every 3 months for up to 12 months after enrollment)
  • The life quality of bipolar patients(every 3 months for up to 12 months after enrollment)
  • Numbers and time of emergency use and hospitalization(every 3 months for up to 12 months after enrollment)
  • Suicidal ideation and number of suicidal attempt(every 3 months for up to 12 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen-Ju Lin

senior visiting staff

Mackay Memorial Hospital

研究点 (2)

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