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Treatment of Functional Movement Disorders With Psychotherapy

Primary Purpose

Movement Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Psychotherapy
Cognitive behavior therapy based on self help
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders focused on measuring Psychogenic Movement Disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • INCLUSION CRITERIA:
  • Must have participated in Protocol 07-N-0190 ( Neurobiological studies of psychogenic movement disorder and non-epileptic seizure )
  • Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist
  • Patients who have active movement symptoms at baseline and score at least 20 percent less than the maximum score on the Neuro-QOL Item Bank
  • Able to give informed consent
  • All participants should be English-speaking
  • Age 18 or older
  • Willingness to come without reimbursement to treatment visits for up to 6 months
  • Willingness to remain on the same medications for the entire duration of the study

EXCLUSION CRITERIA:

  • Have significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
  • Patients with psychotic disorders or bipolar disorder
  • Patients with history of alcohol and substance use disorders within the last year, as defined by the DSM-IV-TR (nicotine and caffeine use is not criterion for exclusion)
  • Current suicidal/homicidal ideation
  • Disease severity requiring inpatient treatment. Chronic pain requiring treatment with narcotic medication

ADDITIONAL EXCLUSIONAL CRITERIA FOR MRI:

  • Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI
  • Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations
  • History of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds
  • Contraindication to MRI
  • Pregnancy
  • Patients with current post-traumatic stress disorder, panic disorder or obsessive compulsive disorders
  • Patients on tricyclic antidepressants or antiepileptic medications.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Ability to participate in social roles and activities (Neuro-QOL Item Bank)

Secondary Outcome Measures

Somatic symptoms (SCL-90).
Self assessment of disease severity (5 point Likert scale).
Subjective and objective depressive and anxiety symptoms.
Clinical Global impression of severity (CGI).

Full Information

First Posted
January 26, 2013
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01778517
Brief Title
Treatment of Functional Movement Disorders With Psychotherapy
Official Title
Treatment of Functional Movement Disorders With Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 23, 2015
Overall Recruitment Status
Completed
Study Start Date
December 11, 2012 (undefined)
Primary Completion Date
July 23, 2015 (Actual)
Study Completion Date
July 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. 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 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. Patient and physician rated assessment of disease severity (5 point Likert scales). Somatic symptoms (SCL-90). Insight, measures with the Brown Assessment of Beliefs Scale (BABS) Similar measures at 12 months after initiation of therapy. MRI studies (resting state BOLD fMRI, DTI, VBM) comparison between baseline (protocol 07-N-0190) and 6 months after initiation of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders
Keywords
Psychogenic Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Group Psychotherapy
Intervention Type
Other
Intervention Name(s)
Cognitive behavior therapy based on self help
Primary Outcome Measure Information:
Title
Ability to participate in social roles and activities (Neuro-QOL Item Bank)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Somatic symptoms (SCL-90).
Time Frame
at baseline
Title
Self assessment of disease severity (5 point Likert scale).
Time Frame
3 months
Title
Subjective and objective depressive and anxiety symptoms.
Time Frame
6 months
Title
Clinical Global impression of severity (CGI).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Must have participated in Protocol 07-N-0190 ( Neurobiological studies of psychogenic movement disorder and non-epileptic seizure ) Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist Patients who have active movement symptoms at baseline and score at least 20 percent less than the maximum score on the Neuro-QOL Item Bank Able to give informed consent All participants should be English-speaking Age 18 or older Willingness to come without reimbursement to treatment visits for up to 6 months Willingness to remain on the same medications for the entire duration of the study EXCLUSION CRITERIA: Have significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy Patients with psychotic disorders or bipolar disorder Patients with history of alcohol and substance use disorders within the last year, as defined by the DSM-IV-TR (nicotine and caffeine use is not criterion for exclusion) Current suicidal/homicidal ideation Disease severity requiring inpatient treatment. Chronic pain requiring treatment with narcotic medication ADDITIONAL EXCLUSIONAL CRITERIA FOR MRI: Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations History of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds Contraindication to MRI Pregnancy Patients with current post-traumatic stress disorder, panic disorder or obsessive compulsive disorders Patients on tricyclic antidepressants or antiepileptic medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hallett, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7872143
Citation
Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.
Results Reference
background
PubMed Identifier
10644789
Citation
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.
Results Reference
background
PubMed Identifier
11513100
Citation
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.
Results Reference
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Treatment of Functional Movement Disorders With Psychotherapy

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