Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Functional Movement Disorders (Espay and Lang, 2015)
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Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study.
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Patients should be able to attend the one-month ambulatory regime and follow-up visits.
Exclusion Criteria:
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Any condition that avoid the patient from giving free consent to participate in the study.
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Any non-controlled psychiatric disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS) | Sevilla | Spain | 41013 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Fundación Caser
Investigators
- Principal Investigator: Pablo Mir, MD, PhD, Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1633-N-21