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NCT Number: NCT05634486

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

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.

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Key information

Conditions

Functional Neurological Disorder Conversion Disorder Functional Movement Disorder Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

Behavioral

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

Psychoeducation (Sham intervention)

Other

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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

Secondary outcomes

  1. Quality of Life in caregivers of patients with functional movement disorders

    Time frame: 3th-month and 5th-month follow-ups

    Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview

  2. Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale

    Time frame: 3th-month and 5th-month follow-ups

    Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity

  3. Improvement of functional neurological symptoms of patients with functional movement disorders

    Time frame: 3th-month and 5th-month follow-ups

    Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement

  4. Severity of functional neurological symptoms of patients with functional movement disorders

    Time frame: 3th-month and 5th-month follow-ups

    Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Fundación Caser

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2022
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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