Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia

Official title

Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia

Overview

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).

Detailed description

Snoezelen® room, as a multisensory interaction environment that has been widely used in studies involving older adults, people with neurological conditions (including children and adults with disabilities), neurodegenerative conditions, and people struggling with depressive and anxiety disorders. Scientific evidence indicates a significant reduction in depression and anxiety levels in people using Snoezelen® therapy, as well as an improvement in the quality of life of people with intellectual disabilities. In a recent case study, Snoezelen® therapy improved emotion recognition and the development of emotional functions in a patient with alexithymia, highlighting the potential of this therapy in psychiatric rehabilitation.

To date, few scientific studies of Snoezelen® therapy have been conducted with psychiatric patients, as confirmed by a recent review (Hudon et al. 2023). There have also been no studies of Snoezelen® therapy specifically targeting groups of patients struggling with addiction or schizophrenia. The lack of scientific evidence regarding the potential impact of Snoezelen® therapy on improving outcomes in psychiatric patients prompted the development of this study to better understand the effectiveness of the therapy in this patient group.

The results obtained in the study will be innovative and will allow us to answer the question whether therapy in the Snoezelen ® room in people suffering from schizophrenia and adults with alcohol addiction will result in improved cognitive functioning, organization of daily activities, improvement in the negative symptoms of schizophrenia, improvement in mood, including a reduction in emotions such as anxiety and sadness, as well as an increase in the patient's overall quality of life and emotional intelligence.

Interventions

• Other Snoezelen® therapy for 6 weeks
  The each session of Snoezelen® therapy will last 30 minutes and will include: 1. preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems, 2. careful observation and appropriate care of the patient, 3. grading of stimuli and their appropriate stimulation, 4. experiencing therapeutic activities together with the patient, 5. recording the therapist's presence and comments on the therapy card.
• Other Snoezelen® therapy for 12 weeks
  Description: The each session of Snoezelen® therapy will last 30 minutes and will include: a) preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems, b) careful observation and appropriate care of the patient, c) grading of stimuli and their appropriate stimulation, d) experiencing therapeutic activities together with the patient, e) recording the therapist's presence and comments on the therapy card.

Primary outcome measures

• outcomes in patients suffering from schizophrenia requiring institutional care - MOCA or ACE-III [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia requiring institutional care - BDI or GDS [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia requiring institutional care - Burns Anxiety Inventory [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia requiring institutional care - SWLS [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia requiring institutional care - Barthel Scale [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia requiring institutional care - blood test [Time frame: From enrollment to the end of treatment at 12 weeks]
• Outcomes in patients suffering from schizophrenia - MOCA or ACE-III or CSSS Scale. [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia - PSYRATS [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia - BNSS [Time frame: From enrollment to the end of treatment at 12 weeks]
• outcomes in patients suffering from schizophrenia - Emotional state examination [Time frame: From enrollment to the end of treatment at 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Poland · 2 centers

• Jerzy Kukuczka Academy of Physical Education in Katowice, Poland — Katowice
• Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland — Rybnik

Identifiers

NCT: NCT07748078 · Resolution no. 02-IX/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗