SCHIZOPHRENIA 1 (Disorder)NCT07748078
Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
A study testing Snoezelen® therapy for 6 weeks and Snoezelen® therapy for 12 weeks in people with SCHIZOPHRENIA 1 (Disorder) and Alcohol Use Disorder, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Alcohol Use Disorder, Alcohol Dependence (Primary Condition)
- What is being tested?
- Snoezelen® therapy for 6 weeks and Snoezelen® therapy for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Sep 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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,
- 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.
Who cannot join
- 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;
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- 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
- 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
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
Katowice, Silesian Voivodeship, 40-065
Laura Piejko, PT, PhD, 32 207 51 10, l.piejko@awf.katowice.pl
Laura Piejko, PT, PhD
Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
Rybnik, Silesian Voivodeship, 44-200
Alicja Kosmalska, MD, 032 43 28 217, alicja.kosmalska@psychiatria.com
Laura Piejko, PT, PhD, 032 43 28 185, laura.piejko@psychiatria.com
About this study
Official title: Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
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).
Read the 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.
- Being tested
- Snoezelen® therapy for 6 weeks, Snoezelen® therapy for 12 weeks
- Keywords
- Snoezelen® therapy, Snoezelen, alcohol dependence, schizophrenia
- Medical subject headings
- Alcoholism, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snoezelen® therapy for 6 weeksOther
Also called Snoezelen®
The each session of Snoezelen® therapy will last 30 minutes and will include:
- preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems,
- careful observation and appropriate care of the patient,
- grading of stimuli and their appropriate stimulation,
- experiencing therapeutic activities together with the patient,
- recording the therapist's presence and comments on the therapy card.
Snoezelen® therapy for 12 weeksOther
Also called Snoezelen®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Snoezelen® therapy for 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcomes in patients suffering from schizophrenia requiring institutional care - MOCA or ACE-III
- 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Outcomes in patients suffering from schizophrenia - MOCA or ACE-III or CSSS Scale.
- 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
outcomes in patients (women) addicted to alcohol MOCA or ACE-III
- 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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
- Responsible party
- Principal investigator, Laura Piejko, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Laura Piejko, PT, PhD, Principal investigator, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748078
- Sponsor's protocol ID
- Resolution no. 02-IX/2025
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT07748078
- Acronym / sponsor ID
- Resolution no. 02-IX/2025
- Keywords
- Snoezelen® therapy, Snoezelen, alcohol dependence, schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Collaborators
- Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Snoezelen® therapy for 12 weeksAdults 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. |
| Adults suffering from schizophrenia | Experimental | Other: Snoezelen® therapy for 12 weeksAdults 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. |
| patients (women) treated for alcohol addiction | Experimental | Other: Snoezelen® therapy for 6 weeksPatients (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (31 listed)
- Adults (men) suffering from schizophrenia, N=40
- Adults (women) addicted to alcohol, N= 60
- lack of consent to participate in the study;
- pregnancy;
- psychoactive substances other than alcohol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snoezelen® therapy for 6 weeksAlso: Snoezelen®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 | patients (women) treated for alcohol addiction |
| Snoezelen® therapy for 12 weeksAlso: Snoezelen®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. | Other | Adults suffering from schizophrenia, adults suffering from schizophrenia requiring permanent institutional care |
Primary outcome
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
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.
outcomes in patients suffering from schizophrenia requiring institutional care - BDI or GDS
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia requiring institutional care - Burns Anxiety Inventory
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia requiring institutional care - SWLS
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia requiring institutional care - Barthel Scale
Time frame: From enrollment to the end of treatment at 12 weeks
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).
outcomes in patients suffering from schizophrenia requiring institutional care - blood test
Time frame: From enrollment to the end of treatment at 12 weeks
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.
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
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.
outcomes in patients suffering from schizophrenia - PSYRATS
Time frame: From enrollment to the end of treatment at 12 weeks
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).
outcomes in patients suffering from schizophrenia - BNSS
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia - Emotional state examination
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia - INTE
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients suffering from schizophrenia - blood test
Time frame: From enrollment to the end of treatment at 12 weeks
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.
outcomes in patients (women) addicted to alcohol MOCA or ACE-III
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - Emotional state
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - Anxiety levels - Burns Anxiety Inventory
Time frame: From enrollment to the end of treatment at 6 weeks
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.
outcomes in patients (women) addicted to alcohol - Anxiety levels - STAI
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - CISS
Time frame: From enrollment to the end of treatment at 6 weeks.
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").
outcomes in patients (women) addicted to alcohol - SWLS
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - INTE
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - blood test
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
outcomes in patients (women) addicted to alcohol - follow up PACS Scale
Time frame: 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).
* 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Yes. The study protocol and individual participant data (IPD) will be available upon request form at l.piejko@awf.katowice.pl.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Piejko, PT, PhD principal investigator
The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snoezelen® therapy for 6 weeks and Snoezelen® therapy for 12 weeks in people with SCHIZOPHRENIA 1 (Disorder) and Alcohol Use Disorder, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicja Kosmalska, MD (032 43 28 217, alicja.kosmalska@psychiatria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.