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

Severe Mental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06219265
• Other study ID #: TFM_01_DANZA
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Asociación Canaria de Terapias Creativas (ASCATEC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: September 30, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Severe Mental Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	ASCATEC	Santa Cruz De Tenerife	Islas Canarias

Sponsors (1)

Lead Sponsor	Collaborator
Asociación Canaria de Terapias Creativas (ASCATEC)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Assessment of Cognition in Schizophrenia (BACS)	It is used to quantify cognitive impairment in schizophrenia. BACS includes assessments of verbal memory, working memory (Digit Span), motor speed (Motor Token), verbal fluency, attention and processing speed (Symbol Encoding) and executive function (Tower of London). Each item assessed has its own specific score.; These scores are used to assess performance on each of the BACS subtests. Subsequently, a composite score is usually calculated that summarises the individual's overall cognitive performance.	At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Primary	Montreal Cognitive Assessment (MoCA)	30-question test to assess mild cognitive dysfunction by assessing executive function and visuospatial ability, identification, short-term memory, delayed recall, attention, language, abstraction, animal naming and orientation. Scores range from 0 to 30 and the cut-off point value for a normal score is >26 points. The test is administered in about 10-12 minutes.	At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Primary	Electroencephalogram (EEG)	The brain wave signals shall be recorded by a 14-channel electroencephalogram, whose electrodes (salt sensors) are arranged at positions A F 3, F7, F3, F C 5, T7, P7, O1, O2, P8, T8, F C 6, F4, F8 and A F 4, according to the international 10-20 system. The device also has 2 reference points at positions P3 and P4.	At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Secondary	Positive and Negative Symptom Scale (PANSS)	It monitors the progress of symptoms in severe mental disorders by means of 30 items that are grouped into three main dimensions: positive symptoms, negative symptoms and general symptoms. Each item is scored from 0 (no symptoms) to 7 (extreme severity) points.	At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.