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NCT07748078
Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
Conditions: SCHIZOPHRENIA 1 (Disorder), Alcohol Use Disorder, Alcohol Dependence (Primary Condition)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Location: Jerzy Kukuczka Academy of Physical Education in Katowice, Poland Katowice Silesian Voivodeship
Summary
The purpose of the study: obtaining knowledge about the impact of Snoezelen® therapy on the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol.
The main questions it aims to answer are:
Does Snoezelen therapy improve the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol?
The participant will participate in Snoezelen® therapy for 6 or 12 weeks, 2 times a week (30 minutes each session).
Eligibility Criteria
1. Adults suffering from schizophrenia requiring permanent institutional care, N=40
Inclusion criteria:
* women and men aged ≥ 18 years,
* consent of the patient or legal guardian to participate in the study,
* schizophrenia clinically confirmed for at least 5 years, with predominance of negative symptoms,
* stable drug therapy (treatment unchanged for at least 3 months)
* ability to understand and follow the therapist's instructions,
* functional ability of everyday life on the Barthel scale below 40 points,
Exclusion criteria:
* lack of consent to participate in the study;
* pregnancy;
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
* diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
2. Adults (men) suffering from schizophrenia, N=40
Inclusion criteria:
* men aged ≥ 18 years,
* consent of the patient or legal guardian to participate in the study,
* clinically confirmed schizophrenia with predominance of negative symptoms,
* stable drug therapy (treatment unchanged for at least 1 month),
* ability to understand and follow the therapist's instructions,
* functional ability of everyday life on the Barthel scale above 40 points,
Exclusion criteria:
* lack of consent to participate in the study;
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli; diseases and illnesses of the musculoskeletal system disturbing body balance and limb mobility.
3. Adults (women) addicted to alcohol, N= 60
Inclusion criteria:
* female gender;
* age ≥ 18 years;
* consent of the patient or legal guardian to participate in the study;
* alcohol dependence syndrome (F10.2 according to ICD-10);
* history of depressive and anxiety symptoms;
* ability to understand and follow the therapist's instructions;
* functional ability of everyday life on the Barthel scale above 40 points.
Exclusion criteria:
* lack of consent to participate in the study;
* pregnancy;
* psychoactive substances other than alcohol;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* mental illnesses other than depression and anxiety disorders;
* psychotic diseases (F20- schizophrenia and other schizophrenic disorders);
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
* severe cognitive impairment;
* diagnosis of autism and ADHD;
* PTSD;
* intellectual disability (diagnosis F70 - F79);
* diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
Source: ClinicalTrials.gov (NCT07748078). StuddyBuddy aggregates publicly available trial information.