Severe Mental Disorder Clinical Trial
Official title:
Neuropsychological and Electrophysiological Effects of Dance Therapy With People With Severe Mental Disorders
Verified date | January 2024 |
Source | Asociación Canaria de Terapias Creativas (ASCATEC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | ASCATEC | Santa Cruz De Tenerife | Islas Canarias |
Lead Sponsor | Collaborator |
---|---|
Asociación Canaria de Terapias Creativas (ASCATEC) |
Spain,
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. |
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