Treatment of Functional Movement Disorders With Psychotherapy
- 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.
Other: Group Psychotherapy
Other: Cognitive behavior therapy based on self help
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Functional Movement Disorders With Psychotherapy|
- Ability to participate in social roles and activities (Neuro-QOL Item Bank) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Somatic symptoms (SCL-90). [ Time Frame: at baseline ] [ Designated as safety issue: No ]
- Self assessment of disease severity (5 point Likert scale). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Subjective and objective depressive and anxiety symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clinical Global impression of severity (CGI). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Other: Group Psychotherapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778517
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|Contact: Mark Hallett, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|