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| ID | Type | Description | Link |
|---|---|---|---|
| 13-N-0047 |
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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:
Objectives:
This is an exploratory study of two options for treating functional movement disorders (FMD):
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.
Design:
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. At the end of the study, all subjects will undergo the same MRI studies they completed as part of protocol 07-N-0190 baseline assessment. Patients will be evaluated with the scales described below.
Those who meet the inclusion criteria and who live locally will be invited to participate in a treatment study of group psychotherapy. 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 group participants will be asked to sign a therapy contract , a nonbinding group therapy conduct guideline.
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-based guided self-help; 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 about 6 months. Subjects will undergo the same assessments as patients in the group psychotherapy arm of the study at the same time points. Only participants in the standard of care arm who successfully complete the whole study will be offered the CBT-based guided self-help therapy after study completion.
Outcome measures:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Psychotherapy | Other | |||
| Cognitive behavior therapy based on self help | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to participate in social roles and activities (Neuro-QOL Item Bank) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Somatic symptoms (SCL-90). | at baseline | |
| Self assessment of disease severity (5 point Likert scale). | 3 months | |
| Subjective and objective depressive and anxiety symptoms. |
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EXCLUSION CRITERIA:
ADDITIONAL EXCLUSIONAL CRITERIA FOR MRI:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Hallett, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7872143 | Background | Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available. | |
| 10644789 | Background | Carson AJ, Ringbauer B, Stone J, McKenzie L, Warlow C, Sharpe M. Do medically unexplained symptoms matter? A prospective cohort study of 300 new referrals to neurology outpatient clinics. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):207-10. doi: 10.1136/jnnp.68.2.207. |
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| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 6 months |
| Clinical Global impression of severity (CGI). | 12 months |
| 11513100 | Background | Feinstein A, Stergiopoulos V, Fine J, Lang AE. Psychiatric outcome in patients with a psychogenic movement disorder: a prospective study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Jul-Sep;14(3):169-76. |