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

NCT06219265 | Unknown

• 1 other identifier: TFM_01_DANZA
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Disorder

Keywords

Dance Therapy; Electroencephalography; Cognition; Severe Mental Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• Positive and Negative Symptom Scale (PANSS)

  At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.

Study Arms (2)

Experimental group 1: people with SMD receiving dance therapy

EXPERIMENTAL

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.

Behavioral: Dance Therapy

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

NO INTERVENTION

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

Interventions

Dance Therapy 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.

Experimental group 1: people with SMD receiving dance therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación Canaria de Terapias Creativas (ASCATEC): lead

Study Sites (1)

ASCATEC

Santa Cruz de Tenerife, Canary Islands, 38003, Spain

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Dance Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise Movement Techniques; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nayra Caballero Estebaranz

  ASCATEC and European University of the Canary Islands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ASCATEC and Department of Health Sciences, European University of the Canary Islands

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 23, 2024
• Study Start: September 12, 2023
• Primary Completion: January 15, 2024
• Study Completion: September 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

ES (1)