Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia | NCT07748078

NCT07748078

Overview

NCT ID: NCT07748078
Lead Sponsor: The Jerzy Kukuczka Academy of Physical Education in KatowiceOTHER
Official Title: Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
Brief 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).
Conditions: SCHIZOPHRENIA 1 (Disorder)
Alcohol Use Disorder
Alcohol Dependence (Primary Condition)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Jul 31, 2027Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

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.

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 140Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
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Contacts and Locations

Central Contacts: Alicja Kosmalska, MDContact
alicja.kosmalska@psychiatria.com

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Participant Group/Arms

Standard Therapy in Control GroupNo Intervention

In all control groups, for ethical reasons, a standard therapy based on the principles of best clinical practice will be conducted. There will be 3 control groups: 1. patients suffering from schizophrenia control group, N = 20, standard therapy based on the principles of best clinical practices will be conducted for 12 weeks. 2. patients suffering from schizophrenia control group requiring permanent institutional care, N = 20, standard therapy based on the principles of best clinical practices will be conducted for 12 weeks. 3. patients (women) treated for alcohol addiction, N = 30, standard therapy based on the principles of best clinical practices will be conducted for 6 weeks.

adults suffering from schizophrenia requiring permanent institutional careExperimental

Adults suffering from schizophrenia requiring permanent institutional care, N= 20 Snoezelen® therapy will be conducted twice a week (for 30 minutes) for 12 weeks. The goal of the therapy will be to improve cognitive functioning, organization in daily activities, mood, including reducing emotions such as anxiety and sadness, and to increase the patient's overall quality of life.

Other: Snoezelen® therapy for 12 weeks

Adults suffering from schizophreniaExperimental

Adults suffering from schizophrenia, N= 20 Snoezelen® therapy will be conducted twice a week (for 30 minutes) for 12 weeks. The goal of the therapy will be to improve cognitive functioning, organization of daily activities, mood improvement, including reducing emotions such as anxiety and sadness, as well as increasing the patient's overall quality of life and emotional intelligence.

Other: Snoezelen® therapy for 12 weeks

patients (women) treated for alcohol addictionExperimental

Patients (women) treated for alcohol addiction, N= 30. Snoezelen ® therapy will be used twice a week (for 30 minutes) for 6 weeks. Then, 4 weeks after the end of therapy (so-called follow-up ), a telephone interview will be conducted to assess mood and the short Penn Alcohol Craving Scale. The goal of the therapy will be to improve cognitive functioning, organization of daily activities, mood improvement, including reducing emotions such as anxiety and sadness, as well as increasing the patient's overall quality of life and emotional intelligence.

Other: Snoezelen® therapy for 6 weeks