Movement DisordersNCT01778517
Treatment of Functional Movement Disorders With Psychotherapy
A study testing Group Psychotherapy and Cognitive behavior therapy based on self help in people with Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Group Psychotherapy and Cognitive behavior therapy based on self help
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2012to 23 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Movement Disorders
- Being tested
- Group Psychotherapy, Cognitive behavior therapy based on self help
- Keywords
- Psychogenic Movement Disorders
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PsychotherapyOther
Cognitive behavior therapy based on self helpOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to participate in social roles and activities (Neuro-QOL Item Bank)
Measured: 6 months
Secondary outcomes (4)
Somatic symptoms (SCL-90).
Measured: at baseline
Self assessment of disease severity (5 point Likert scale).
Measured: 3 months
Subjective and objective depressive and anxiety symptoms.
Measured: 6 months
Clinical Global impression of severity (CGI).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study start11 Dec 2012
- Primary completion23 Jul 2015
- Study completion23 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778517
- Sponsor's protocol ID
- 130047
- Other IDs
- 13-N-0047
- Status last verified
- 23 Jul 2015
- First submitted
- 26 Jan 2013
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.
PubMed 7872143Carson 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.
PubMed 10644789Feinstein 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.
PubMed 11513100
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Functional Movement Disorders With Psychotherapy
- ClinicalTrials.gov ID
- NCT01778517
- Acronym / sponsor ID
- 130047
- Conditions
- Movement Disorders
- Keywords
- Psychogenic Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Dec 2012
- Primary completion
- 23 Jul 2015 (actual)
- Study completion
- 23 Jul 2015 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Psychotherapy | Other | – |
| Cognitive behavior therapy based on self help | Other | – |
Primary outcome
Ability to participate in social roles and activities (Neuro-QOL Item Bank)
Time frame: 6 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 7872143Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.
- Background: PubMed 10644789Carson 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.
- Background: PubMed 11513100Feinstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychotherapy and Cognitive behavior therapy based on self help in people with Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to participate in social roles and activities (Neuro-QOL Item Bank) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.