Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders

NCT ID: NCT06219265

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2024-09-30

Brief Summary

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A single-centre prospective randomised controlled trial will be conducted with a minimum of 47 patients with severe mental disorder (SMD) who will be randomly assigned into two groups, 1 intervention group receiving dance therapy (n=26) and 1 control group who will not receive any intervention or added treatment apart from continuing with their usual treatment (pharmacological), but will not receive intervention with dance therapy (n=21).

In summary, the groups are:

* Experimental group (n=26): people with SMD receiving dance therapy.
* Control group (n=21): people with SMD who do not receive the dance therapy intervention but do receive their usual pharmacological treatment.

Tests will be administered before the start of the study and at the end of the study, as well as 3 months after the end of the study in order to compare the results between groups.

Detailed Description

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All the tests (BASC, MoCA, PANSS and EEG) will be carried out with the 47 patients with SMD to find out their baseline status. The people with SMD will be randomly assigned to an experimental group (dance therapy program) or a control group (without intervention in dance therapy but with regular pharmacological treatment). The study will last approximately 1 year between the administration of tests, the program and the analysis of results. The dance therapy program will last 20 sessions over 10 weeks. The sessions will take place at the headquarters of the Canarian Association of Creative Therapies (ASCATEC) in the 21st century space in Santa Cruz de Tenerife.

The 26 people with SMD in the experimental group will participate in a 10-week intervention program with 2 sessions per week in which they will work for 1 hour on memory, attention and executive functions through dance and movement, ending with 10 minutes of Mindfulness.

The 21 people in the control group will not receive any type of dance therapy intervention, but will continue with their usual pharmacological treatment.

The effects will be measured after a treatment of 20 sessions (twice a week). Results will be obtained by analysing EEG parameters (EEG amplitude and frequency) and cognitive functions (BACS and MoCA). On the other hand, at the end of the 20-session programme, tests will also be administered to assess the symptomatology of the severe mental disorder suffered by the person (PANSS) to assess the effects of the program on these variables.

Conditions

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Severe Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group 1: people with SMD receiving dance therapy

Intervention group of people with SMD (n=26) who receive a 20-session dance therapy program for 10 weeks with 2 sessions per week in which they work for 1 hour on memory, attention and executive functions through dance and movement, ending with 10 minutes of Mindfulness.

Group Type EXPERIMENTAL

Dance Therapy

Intervention Type BEHAVIORAL

A single-centre prospective randomised controlled trial will be conducted with a minimum of 48 patients with severe mental disorder (SMD) who will be randomised into two groups, 1 intervention group receiving dance therapy (n=24) and 1 control group receiving no intervention or treatment (n=24).

In addition, there will be an intervention group of healthy people who will receive dance therapy (n=20).

All the tests, will be carried out with patients with SMD and only the EEG for healthy people, in order to determine their baseline state. The dance therapy program will last for 20 sessions over 10 weeks.

The 44 people in the two experimental groups will participate in a 10-week intervention program with 2 sessions per week in which they will work for 1 hour on memory, attention and executive functions through dance and movement, ending with 10 minutes of Mindfulness.

The 24 people in the control group will not receive any type of intervention.

Control group: people with SMD who do not receive any intervention

This group of 21 persons with SMD will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dance Therapy

A single-centre prospective randomised controlled trial will be conducted with a minimum of 48 patients with severe mental disorder (SMD) who will be randomised into two groups, 1 intervention group receiving dance therapy (n=24) and 1 control group receiving no intervention or treatment (n=24).

In addition, there will be an intervention group of healthy people who will receive dance therapy (n=20).

All the tests, will be carried out with patients with SMD and only the EEG for healthy people, in order to determine their baseline state. The dance therapy program will last for 20 sessions over 10 weeks.

The 44 people in the two experimental groups will participate in a 10-week intervention program with 2 sessions per week in which they will work for 1 hour on memory, attention and executive functions through dance and movement, ending with 10 minutes of Mindfulness.

The 24 people in the control group will not receive any type of intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Persons diagnosed with a serious mental disorder according to the Diagnostic and Statistical Manual of Mental Disorders -V.
* Have the capacity to decide and consent.
* Be between 18 and 75 years of age.
* No active consumption of toxic substances (except nicotine).
* Commitment to attend for the entire study period from December 2023 to December 2024.

Exclusion Criteria

* Not having given free consent to participate in the study.
* Having a comorbid severe mental disorder, associated intellectual disability, history of severe brain damage or neurological disorder that may function as a confounding factor (Associated organic-type disorder, borderline or lower IQ)
* Active substance abuse (except nicotine)
* Having a cochlear implant, fixed hearing aids or plates in the head.
* Having suffered a concussion to the head with loss of consciousness that subsequently triggered symptoms related to the pathology.
* Having suffered from epileptic seizures.
* Not having the desire to participate in dance therapy sessions for any reason or to undergo electroencephalogram testing.
* Currently involved and participating in another cognitive rehabilitation program.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación Canaria de Terapias Creativas (ASCATEC)

OTHER

Sponsor Role lead

Responsible Party

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Nayra Caballero Estebaranz

Director of ASCATEC and Department of Health Sciences, European University of the Canary Islands

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayra Caballero Estebaranz

Role: PRINCIPAL_INVESTIGATOR

ASCATEC and European University of the Canary Islands

Locations

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ASCATEC

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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TFM_01_DANZA

Identifier Type: -

Identifier Source: org_study_id

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