Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders

Study Overview
=================
Brief Summary
-----------------
Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.

Official Title
-----------------
Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers

Conditions
-----------------
Functional Neurological Disorder, Functional Movement Disorder

Intervention / Treatment
-----------------
* Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
* Other: Psychoeducation (Sham intervention)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Functional Movement Disorders (Espay and Lang, 2015) Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study. Patients should be able to attend the one-month ambulatory regime and follow-up visits. Exclusion Criteria: Any condition that avoid the patient from giving free consent to participate in the study. Any non-controlled psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 40 patients with functional movement disorders will be randomized into two arms of treatments: a one-month multidisciplinary treatment (physiotherapy + cognitive-behavioral therapy) versus a one-month psychoeducation sham intervention (control group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary therapeutic approach<br>Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist). 12 physiotherapy sessions during one month (three 60-minute sessions per week) administered by a physiotherapist with experience in functional neurological disorders. 4 cognitive-behavioral therapy sessions during one month (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy. | Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)<br>* Patients randomly allocated to this arm of intervention will receive an ambulatory therapy regime of twelve 60-minute physiotherapy sessions plus four 60-minute psychotherapy sessions throughout one month of treatment<br>|
| Sham Comparator: Psychoeducation<br>Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist). 4 psychoeducational sessions (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy. | Other: Psychoeducation (Sham intervention)<br>* Patients randomly allocated to this arm of intervention will receive an ambulatory regime of four 60-minute non-organized psychoeducational sessions throughout one month of treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale | Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS). | 3th-month and 5th-month follow-ups | 
| Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system. | Change in the patients' quality of life measured by changes in EQ-5D-5L - EQ-5D descriptive system. The digits for the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state. | 3th-month and 5th-month follow-ups | 
| Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36) | Change in the patients' quality of life measured by changes in SF-36 | 3th-month and 5th-month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in caregivers of patients with functional movement disorders | Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview | 3th-month and 5th-month follow-ups | 
| Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale | Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity | 3th-month and 5th-month follow-ups | 
| Improvement of functional neurological symptoms of patients with functional movement disorders | Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement | 3th-month and 5th-month follow-ups | 
| Severity of functional neurological symptoms of patients with functional movement disorders | Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale | 3th-month and 5th-month follow-ups |