NCT01778517已完成不适用
Treatment of Functional Movement Disorders With Psychotherapy
National Institute of Neurological Disorders and Stroke (NINDS)2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年12月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Ability to participate in social roles and activities (Neuro-QOL Item Bank)
研究概览
简要总结
Background:
- Functional movement disorder (FMD) is a form of conversion disorder (CD). CD is a disorder in which a person has neurological symptoms that do not have a neurological cause. These symptoms can include pain, weakness, dizziness, and fatigue. Some thoughts on CD suggest that it may come from feelings of anxiety that are converted into physical symptoms. Treatment for FMD usually involves stress reduction, family help, and regular doctor s appointments. Therapy interventions, however, have not been well studied. Researchers want to see if people with FMD get better with psychotherapy. They will study two different types of psychotherapy: group therapy and a self-help manual.
Objectives:
- To test two different types of therapy treatments for FMD.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.
Design:
- Participants will be screened with a physical exam and medical history. They will also have a psychological exam, and answer questions about their mood and symptoms.
- Participants will be separated into three groups. One group will have group therapy. Another will use a self-help workbook designed for people with FMD, and have individual therapy sessions. A third group will just have standard care. During the study, participants will continue to see their regular doctor.
- Group therapy participants will meet once a week for 6 months at the National Institutes of Health clinical center. There will be 8 to 10 people per group. Sessions will last 75 minutes. These sessions will work on methods for treating FMD.
- Self-help workbook participants will have six individual therapy sessions over 3 to 4 months. They will use the workbooks to learn about and practice methods for treating FMD.
- All participants will be evaluated at 3, 6, and 12 months during the study.
- At the end of the study, participants will have a final follow-up session with exams and questions similar to the screening exam. They will return to the care of their regular doctor.
详细描述
Objectives:
This is an exploratory study of two options for treating functional movement disorders (FMD):
- Group psychotherapy
- Cognitive behavioral therapy (CBT)-based guided self-help.
Study population:
We intend to study adult patients with diagnoses of FMD seen by the Human Motor Control Section Clinic (HMCS) and who live in the Washington-Baltimore metropolitan area for group psychotherapy as well as patients who live out of the area for CBT-based guided self-help.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ability to participate in social roles and activities (Neuro-QOL Item Bank)
时间窗: 6 months
次要结局
- Somatic symptoms (SCL-90).(at baseline)
- Self assessment of disease severity (5 point Likert scale).(3 months)
- Subjective and objective depressive and anxiety symptoms.(6 months)
- Clinical Global impression of severity (CGI).(12 months)
研究者
研究点 (2)
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