NCT07748078

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Sep 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 26, 2026

Last Update Submit

July 31, 2026

Conditions

Keywords

Snoezelen® therapySnoezelenalcohol dependenceschizophrenia

Outcome Measures

Primary Outcomes (21)

  • outcomes in patients suffering from schizophrenia requiring institutional care - MOCA or ACE-III

    1\. Cognitive function testing using the MOCA or ACE-III * The Montreal Cognitive Assessment (MOCA) assesses cognitive function. The test consists of 30 tasks assessing language, memory, reasoning, orientation, visual reasoning, and spatial reasoning. The test takes approximately 10-15 minutes to complete. Maximum score: 30 points. One point is added for individuals with less than 12 years of education. * The Addenbrooke's Cognitive Examination III (ACE-III) is an extended screening tool for cognitive function. The test assesses attention and orientation, memory, verbal fluency, language, and visuospatial functions. The test takes approximately 15 minutes. The maximum score is 100 points. A score below 88 suggests the presence of cognitive impairment and requires further medical evaluation.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia requiring institutional care - BDI or GDS

    Emotional state examination, which will be carried out by determining the degree of: a. Severity of depressive symptoms using the BDI or GDS scale. * The Beck Depression Inventory (BDI) measures the severity of depression symptoms, which includes questions about mood, guilt, and physical symptoms. A score of 0 to 10 indicates no depression, 11 to 27 indicates mild or moderate depression, and 28 or more indicates severe depression. * The GDS-30 (Geriatric Depression Scale) is a screening tool used to assess the severity of depression symptoms in older adults. GDS-30 consists of 30 questions about well-being over the past week. 0-9 points: normal condition (no symptoms of depression); 10-19 points: suspicion of moderate depression; \>20 points: suspicion of severe depression.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia requiring institutional care - Burns Anxiety Inventory

    Emotional state examination, which will be carried out by determining the b. Anxiety levels using the Burns Anxiety Inventory The questionnaire consists of 33 questions divided into three main categories, which the patient rates based on their experience over the past week: Anxious feelings - 6 items (e.g., nervousness, sense of impending doom, panic attacks). Anxious thoughts - 11 items (e.g., fear of losing control, fear of going crazy or becoming physically ill). Physical symptoms - 16 items (e.g., heart palpitations, dizziness, muscle tension, shortness of breath). Scoring: Each of the 33 questions is rated on a 4-point Likert scale from 0 to 3 points: 0 - Not at all / did not bother 1 - A little / slightly 2 - Moderate 3 - Very much. The total score ranges from 0 to 99 points. Interpretation of results: 0-4 points: Minimal or no anxiety, 5-10 points: Anxiety very mild, 11-20 points: Mild anxiety, 21-30 points: Moderate anxiety, 31-50 points: Severe anxiety.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia requiring institutional care - SWLS

    Life satisfaction using the SWLS scale The SWLS (Satisfaction with Life Scale) is a short psychological tool used to assess overall life satisfaction. It consists of five statements, which the respondent rates on a seven-point scale. It is intended for adults, both healthy and sick, and takes approximately two minutes to complete. The scasle contains five statements regarding satisfaction with one's overall life. Response Format: Seven-point Likert scale (from 1 - I completely disagree to 7 - I completely agree). Score: overall life satisfaction index = the higher the score, the greater the sense of satisfaction.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia requiring institutional care - Barthel Scale

    Examination of activities of daily living using the Barthel scale. The Barthel Scale is a popular medical tool used to assess a patient's independence in 10 basic activities of daily living, such as eating, dressing, and using the toilet. The maximum score is 100 points, and the score indicates the patient's need for assistance from others. Interpretation of scores: 85-100 points: good condition, the patient is independent. 21-84 points: moderate or moderately severe disability, the patient requires varying degrees of assistance. 0-20 points: severe disability, the patient is completely dependent on others (a score of 40 or less qualifies the patient for long-term care).

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia requiring institutional care - blood test

    Blood concentration testing for selected biological factors. Patients will have 5 ml of venous blood drawn twice (before and after completing the study) to perform the blood test.

    From enrollment to the end of treatment at 12 weeks

  • Outcomes in patients suffering from schizophrenia - MOCA or ACE-III or CSSS Scale.

    1\. Cognitive function testing using the MOCA or ACE-III or the CSSS Scale. The MOCA or ACE-III scales are described above in the outcomes in patients suffering from schizophrenia requiring institutional care group. The Cognitive Screening Scale for Schizophrenia (CSSS) is a brief diagnostic tool used to quickly detect cognitive deficits in people with schizophrenia. This scale assesses the patient's overall cognitive performance, is time-consuming, and aids in qualifying patients for rehabilitation. Higher scores indicate better cognitive functioning.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia - PSYRATS

    The intensity of positive or negative symptoms is assessed using the PSYRATS Psychotic Symptom Rating Scale and the BNSS (Brief Negative Syndrome Scale). -The PSYRATS Scale (Psychotic Symptom Rating Scale) is a multidimensional tool for the assessment of auditory hallucinations and delusions, consisting of two subscales (for hallucinations and delusions) rated from 0 to 4. Scale Structure: Auditory Hallucinations Subscale (AHS): contains 11 questions, including questions about frequency, duration, loudness, content, degree of distress, and belief in the reality of voices. Delusions Subscale (DS): contains 6 questions, including questions about the degree of preoccupation, belief in reality, and anxiety. Assessment Method: Each symptom feature (dimension) is scored on a scale from 0 (no symptom) to 4 (maximum severity).

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia - BNSS

    The intensity of positive or negative symptoms is assessed using the BNSS (Brief Negative Syndrome Scale). -The Brief Negative Symptom Scale (BNSS) is a clinical tool used to assess the severity of symptoms in schizophrenia. Its basic information and structure consist of 13 questions divided into 6 main subscales. The test format: a semi-structured patient interview combined with clinical observation. Duration: approximately 15 minutes. Scoring range: 0 (no symptom) to 6 (extreme severity) for each item; the total score ranges from 0 to 78 points.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia - Emotional state examination

    Emotional state examination, which will be carried out by determining the degree of: * Severity of depressive symptoms using the BDI or GDS or CES-D * Anxiety level using the Burns Anxiety Inventory or the STAI Anxiety Inventory. * Satisfaction with life using the SWLS scale. STAI Scale The STAI (State-Trait Anxiety Inventory) measures two distinct types of anxiety: State Anxiety (the X-1 scale for temporary feelings) and Trait Anxiety (long-term feelings). The STAI is a tool for assessing anxiety, understood as a transient and situationally determined individual state, and anxiety, understood as a relatively stable personality trait. It is used for screening and individual assessment; the X-1 scale is also useful in experimental studies requiring the recording of changes in anxiety intensity. * The other mentioned scales are described above in the outcomes in patients suffering from schizophrenia requiring institutional care group.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia - INTE

    Emotional intelligence testing with the INTE Emotional Intelligence Questionnaire. The INTE questionnaire measures emotional intelligence, defined as the ability to recognize, understand, and control one's own and others' emotions, as well as the ability to effectively use emotions to guide one's own and others' actions. It is primarily used for research purposes. The survey lasts approximately 10 minutes. Sum of item values give a total emotional intelligence metric.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients suffering from schizophrenia - blood test

    Description: Blood concentration testing for selected biological factors. Patients will have 5 ml of venous blood drawn twice (before and after completing the study) to perform the blood test.

    From enrollment to the end of treatment at 12 weeks

  • outcomes in patients (women) addicted to alcohol MOCA or ACE-III

    1\. Cognitive function testing using the MOCA or ACE-III diagnostic tools The Montreal Cognitive Assessment (MOCA) and the Addenbrooke's Cognitive Examination-III (ACE-III) are key medical tests used to find cognitive impairment. Cognitive function testing using the MOCA or ACE-III - The Montreal Cognitive Assessment (MOCA) assesses cognitive function. The test consists of 30 tasks assessing language, memory, reasoning, orientation, visual reasoning, and spatial reasoning. The test takes approximately 10-15 minutes to complete. Maximum score: 30 points. One point is added for individuals with less than 12 years of education. - The Addenbrooke's Cognitive Examination III (ACE-III) is an extended screening tool for cognitive function. The test assesses attention and orientation, memory, verbal fluency, language, and visuospatial functions. The test takes approximately 15 minutes. The maximum score is 100 points. A score below 88 suggests the presence of cognitive impairment.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - Emotional state

    Emotional state examination, which will be carried out by determining the degree of severity of depressive symptoms using the BDI or GDS or CES-D scale (The Center for Epidemiologic Studies Depression Scale). The Beck Depression Inventory (BDI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Geriatric Depression Scale (GDS) are three widely used self-report tools to screen for and measure the severity of depressive symptoms.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - Anxiety levels - Burns Anxiety Inventory

    Anxiety levels using the Burns Anxiety Inventory Burns Anxiety Inventory The questionnaire consists of 33 questions divided into three main categories, which the patient rates based on their experience over the past week: Anxious feelings - 6 items (e.g., nervousness, sense of impending doom, panic attacks). Anxious thoughts - 11 items (e.g., fear of losing control, fear of going crazy or becoming physically ill). Physical symptoms - 16 items (e.g., heart palpitations, dizziness, muscle tension, shortness of breath). Scoring: Each of the 33 questions is rated on a 4-point Likert scale from 0 to 3 points: 0 - Not at all / did not bother 1 - A little / slightly 2 - Moderate 3 - Very much. The total score ranges from 0 to 99 points. Interpretation of results: 0-4 points: Minimal or no anxiety, 5-10 points: Anxiety very mild, 11-20 points: Mild anxiety, 21-30 points: Moderate anxiety, 31-50 points: Severe anxiety.

    From enrollment to the end of treatment at 6 weeks

  • outcomes in patients (women) addicted to alcohol - Anxiety levels - STAI

    Emotional state examination, which will be carried out by determining the degree of: b. Anxiety levels using the Burns Anxiety Inventory or STAI State-Trait Anxiety Inventory. The STAI (State-Trait Anxiety Inventory) measures two distinct types of anxiety: State Anxiety (the X-1 scale for temporary feelings) and Trait Anxiety (long-term feelings). The STAI is a tool for assessing anxiety, understood as a transient and situationally determined individual state, and anxiety, understood as a relatively stable personality trait. It is used for screening and individual assessment; the X-1 scale is also useful in experimental studies requiring the recording of changes in anxiety intensity.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - CISS

    Emotional state examination, which will be carried out by determining the degree of CISS (Coping Inventory for Stressful Situations) Scale. A questionnaire for diagnosing stress coping styles. It is used for research and practical purposes, for example, as a tool in qualification tests for specific job positions in certain professions (police, firefighters, drivers), or in testing individuals applying for firearms licenses. In our study, we aim to determine whether Snoezelen therapy can influence the stress coping style of women addicted to alcohol. Rating Scale: A 5-point frequency scale ranging from 1 ("not at all") to 5 ("very much").

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - SWLS

    Emotional state examination, which will be carried out by determining the degree of: - Satisfaction with life using the SWLS scale. Life satisfaction using the SWLS scale The SWLS (Satisfaction with Life Scale) is a short psychological tool used to assess overall life satisfaction. It consists of five statements, which the respondent rates on a seven-point scale. It is intended for adults, both healthy and sick, and takes approximately two minutes to complete. The scasle contains five statements regarding satisfaction with one's overall life. Response Format: Seven-point Likert scale (from 1 - I completely disagree to 7 - I completely agree). Score: overall life satisfaction index = the higher the score, the greater the sense of satisfaction.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - INTE

    Emotional intelligence testing with the INTE Emotional Intelligence Questionnaire. The INTE questionnaire measures emotional intelligence, defined as the ability to recognize, understand, and control one's own and others' emotions, as well as the ability to effectively use emotions to guide one's own and others' actions. It is primarily used for research purposes. The survey lasts approximately 10 minutes. Sum of item values give a total emotional intelligence metric.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - blood test

    Blood concentration testing for selected biological factors. Patients will have 5 ml of venous blood drawn twice (before and after completing the exercise) to perform the blood test.

    From enrollment to the end of treatment at 6 weeks.

  • outcomes in patients (women) addicted to alcohol - follow up PACS Scale

    \* 4 weeks after the end of study (follow-up), a telephone interview will be conducted with the use of short Penn Alcohol Craving Scale (PACS). The Scale is a self-assessment method, it comprises 5 statements, and is designed to assess alcohol craving experienced by a patient in a week prior to the examination. 0-3 points - low intensity of alcohol craving, 4-9 points - average intensity of alcohol craving, above 10 points - high intensity of alcohol craving.

    4 weeks after the end of study (follow-up), a telephone interview will be conducted with the use of short Penn Alcohol Craving Scale (PACS).

Study Arms (4)

Standard Therapy in Control Group

NO 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 care

EXPERIMENTAL

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 schizophrenia

EXPERIMENTAL

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 addiction

EXPERIMENTAL

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

Interventions

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.

Also known as: Snoezelen®
patients (women) treated for alcohol addiction

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.

Also known as: Snoezelen®
Adults suffering from schizophreniaadults suffering from schizophrenia requiring permanent institutional care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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
  • 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,
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jerzy Kukuczka Academy of Physical Education in Katowice, Poland

Katowice, Silesian Voivodeship, 40-065, Poland

Location

Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland

Rybnik, Silesian Voivodeship, 44-200, Poland

Location

MeSH Terms

Conditions

AlcoholismSchizophrenia

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Laura Piejko, PT, PhD

    The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Group allocation will be random, and the allocation method will be kept confidential to the physician qualifying patients for the study, medical staff, and patients. Group allocation will be performed by the study director (principal investigator), who will not have direct contact with patients before group allocation. Group allocation will be performed using block randomization method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participant will participate in Snoezelen® therapy for 6 weeks (alcohol dependence group) or 12 weeks (schizophrenia group), 2 times a week (30 minutes each session).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD. Head of Clinical Unit of Physiotherapy in Psychiatry, Department of Clinical Physiotherapy at The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland

Study Record Dates

First Submitted

July 26, 2026

First Posted

August 5, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

Shared Documents
ICF
Time Frame
Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
Access Criteria
Individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.

Locations