Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Multidisciplinary therapeutic approach
- 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.
Intervention: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy) (Behavioral)
Psychoeducation
- 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.
Intervention: Psychoeducation (Sham intervention) (Other)
Outcomes
Primary Outcomes
Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)
Time Frame: 3th-month and 5th-month follow-ups
Change in the patients' quality of life measured by changes in SF-36
Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale
Time Frame: 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.
Time Frame: 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.
Secondary Outcomes
- Quality of Life in caregivers of patients with functional movement disorders(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(3th-month and 5th-month follow-ups)
- Improvement of functional neurological symptoms of patients with functional movement disorders(3th-month and 5th-month follow-ups)
- Severity of functional neurological symptoms of patients with functional movement disorders(3th-month and 5th-month follow-ups)