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

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Macías García, MD, PhD; Phone Number: 955923039; Email: dmacias-ibis@us.es

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Multidisciplinary 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
Sham Comparator: 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.	Other: Psychoeducation (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.

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: Fundación Caser
• Investigators: Principal Investigator: Pablo Mir, MD, PhD, Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)

Publications and helpful links

Helpful Links

• Sponsor official statement of financial support

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Movement Disorders; Conversion Disorder; Hysteria
• Other Study ID Numbers: 1633-N-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No