Clinical trial NCT06219265: Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders
Official title: Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Keywords: Dance Therapy
Electroencephalography
Cognition
Severe Mental Disorder
Lead sponsor: Asociación Canaria de Terapias Creativas (ASCATEC)
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
measure: Electroencephalogram (EEG)
timeFrame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Secondary outcomes:
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: ASCATEC
state: Islas Canarias
Study officials:
affiliation: ASCATEC and European University of the Canary Islands
name: Nayra Caballero Estebaranz
role: PRINCIPAL_INVESTIGATOR
References: