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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Completed

Conditions: Functional Movement Disorder; Functional Neurological Disorder

Treatments: Other: Psychoeducation (Sham intervention); Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05634486

1633-N-21

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Multidisciplinary therapeutic approach

Experimental group

Description:

* 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.

Treatment:

Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)

Psychoeducation

Sham Comparator group

Description:

* 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.

Treatment:

Other: Psychoeducation (Sham intervention)