Severe Mental DisorderNCT06219265
Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders
A study testing Dance Therapy in people with Severe Mental Disorder, run by Asociación Canaria de Terapias Creativas (ASCATEC) at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Dance Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Severe Mental Disorder
- Being tested
- Dance Therapy
- Keywords
- Dance Therapy, Electroencephalography, Cognition, Severe Mental Disorder
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start12 Sep 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Canaria de Terapias Creativas (ASCATEC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayra Caballero Estebaranz, Asociación Canaria de Terapias Creativas (ASCATEC)
- Investigators
- Nayra Caballero Estebaranz, Principal investigator, ASCATEC and European University of the Canary Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219265
- Sponsor's protocol ID
- TFM_01_DANZA
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders
- ClinicalTrials.gov ID
- NCT06219265
- Acronym / sponsor ID
- TFM_01_DANZA
- Conditions
- Severe Mental Disorder
- Keywords
- Dance Therapy, Electroencephalography, Cognition, Severe Mental Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Asociación Canaria de Terapias Creativas (ASCATEC)University, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1: people with SMD receiving dance therapy | Experimental | Behavioral: Dance TherapyIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance TherapyA 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. | Behavioural | Experimental group 1: people with SMD receiving dance therapy |
Primary outcome
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
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.
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
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.
Electroencephalogram (EEG)
Time frame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
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.
1 secondary outcome
Positive and Negative Symptom Scale (PANSS)
Time frame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayra Caballero Estebaranz principal investigator
ASCATEC and European University of the Canary Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Therapy in people with Severe Mental Disorder, run by Asociación Canaria de Terapias Creativas (ASCATEC) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Assessment of Cognition in Schizophrenia (BACS) (time frame: At baseline, up to 10 weeks of dance therapy program and 3 months after the end of the program.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.