Functional Movement Disorder, Functional Neurological Disorder
Conditions
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.
Interventions
BEHAVIORALMultidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
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
OTHERPsychoeducation (Sham intervention)
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.
Sponsors
Fundación Caser
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale | 3th-month and 5th-month follow-ups | Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS). |
| Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system. | 3th-month and 5th-month follow-ups | 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. |
| Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36) | 3th-month and 5th-month follow-ups | Change in the patients' quality of life measured by changes in SF-36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in caregivers of patients with functional movement disorders | 3th-month and 5th-month follow-ups | Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview |
| Severity of functional neurological symptoms of patients with functional movement disorders | 3th-month and 5th-month follow-ups | Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale |
| Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale | 3th-month and 5th-month follow-ups | Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity |
| Improvement of functional neurological symptoms of patients with functional movement disorders | 3th-month and 5th-month follow-ups | Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement |
Countries
Spain
Outcome results
None listed