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

Not Applicable

Completed

• Conditions: Functional Movement Disorder; Functional Neurological Disorder
• Interventions: Other: Psychoeducation (Sham intervention); Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

• Registration Number: NCT05634486
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-02
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation	Psychoeducation (Sham intervention)	* 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.
Multidisciplinary therapeutic approach	Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)	* 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.

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS); 🇪🇸 Sevilla, Spain