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 ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Other: Group Psychotherapy
This is an exploratory study of two options for treating functional movement disorders (FMD):
- Group psychotherapy
- Cognitive behavioral therapy (CBT)-based guided self-help.
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.
Patients will be screened for participation through protocol 07-N-0190 ( Neurobiology of Psychogenic Movement Disorder and Non-Epileptic Seizures ). Those who meet the inclusion criteria and who live locally will be invited to participate in a treatment study of group psychotherapy. The duration of the study for each patient is one year. Local patients who meet the inclusion criteria will be divided into two groups of 10 patients each. Accrual will be gradual. All 10 patients in each group will start simultaneously. All participants will undergo an initial assessment, followed by an assessment at 3, 6, and 12 months. The primary endpoint will be assessed at 6 months; a group of 20 (out-of-area) patients randomized to standard of care will serve as the control. Patients will be evaluated with the scales described below.
Patients who are out-of-town and meet the inclusion/exclusion criteria will be invited to join the CBT-based guided self-help arm. They will be randomized in two groups of 20 patients each. One group will undergo CBT; the other will be randomized to standard of care. Standard of care is defined as pharmacological or other treatment modalities excluding CBT or group psychotherapy (the studied modalities). Subjects will be included on a rolling basis, and therapy will be delivered approximately once every two weeks for a total of six sessions. Participants will be instructed in the use of CBT-based self-help workbooks aimed at treating functional neurological symptoms (Overcoming unexplained neurological symptoms: a five areas approach by Dr. Chris Williams, 2011, Hodder and Arnold). Total duration of the intervention will be 3-4 months. Subjects will undergo the same assessments as patients in the group psychotherapy arm of the study at the same time points.
Primary Outcome measure
-Ability to participate in social roles and activities (Neuro-QOL Item Bank) at 6 months after initiation of therapy.
Secondary Outcome Measures
- Clinical global impression of severity (CGI).
- Subjective and objective depressive and anxiety symptoms, measured with the Beck Depression Inventory (BDI), Hamilton Depression Rating Scale-17, State Trait Anxiety Inventory (STAI) and Hamilton Anxiety Scale.
- Self-assessment of disease severity (5 point Likert scale).
- Somatic symptoms (SCL-90).
- Insight (ITAQ)
- Similar measures at 12 months after initiation of therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778517
|Contact: Elaine P Considine, R.N.||(301) email@example.com|
|Contact: Mark Hallett, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|