Treatment of Functional Movement Disorders With Psychotherapy
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|ClinicalTrials.gov Identifier: NCT01778517|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : July 2, 2017
- 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.
- To test two different types of therapy treatments for FMD.
- Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Movement Disorders||Other: Group Psychotherapy Other: Cognitive behavior therapy based on self help||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Functional Movement Disorders With Psychotherapy|
|Study Start Date :||December 11, 2012|
|Actual Primary Completion Date :||July 23, 2015|
|Actual Study Completion Date :||July 23, 2015|
- Ability to participate in social roles and activities (Neuro-QOL Item Bank) [ Time Frame: 6 months ]
- Somatic symptoms (SCL-90). [ Time Frame: at baseline ]
- Self assessment of disease severity (5 point Likert scale). [ Time Frame: 3 months ]
- Subjective and objective depressive and anxiety symptoms. [ Time Frame: 6 months ]
- Clinical Global impression of severity (CGI). [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778517
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|