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Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
Condition(s) studied
SCHIZOPHRENIA 1 (Disorder)Alcohol Use DisorderAlcohol Dependence (Primary Condition)
Investigational drug(s) / intervention(s)
Snoezelen® therapy for 6 weeksSnoezelen® therapy for 12 weeks
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.
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.
Study summary
The purpose of the study: obtaining knowledge about the impact of Snoezelen® therapy on the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol.
The main questions it aims to answer are:
Does Snoezelen therapy improve the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol?
The participant will participate in Snoezelen® therapy for 6 or 12 weeks, 2 times a week (30 minutes each session).
Eligibility
1. Adults suffering from schizophrenia requiring permanent institutional care, N=40
Inclusion criteria:
* women and men aged ≥ 18 years,
* consent of the patient or legal guardian to participate in the study,
* schizophrenia clinically confirmed for at least 5 years, with predominance of negative symptoms,
* stable drug therapy (treatment unchanged for at least 3 months)
* ability to understand and follow the therapist's instructions,
* functional ability of everyday life on the Barthel scale below 40 points,
Exclusion criteria:
* lack of consent to participate in the study;
* pregnancy;
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
* diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
2. Adults (men) suffering from schizophrenia, N=40
Inclusion criteria:
* men aged ≥ 18 years,
* consent of the patient or legal guardian to participate in the study,
* clinically confirmed schizophrenia with predominance of negative symptoms,
* stable drug therapy (treatment unchanged for at least 1 month),
* ability to understand and follow the therapist's instructions,
* functional ability of everyday life on the Barthel scale above 40 points,
Exclusion criteria:
* lack of consent to participate in the study;
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli; diseases and illnesses of the musculoskeletal system disturbing body balance and limb mobility.
3. Adults (women) addicted to alcohol, N= 60
Inclusion criteria:
* female gender;
* age ≥ 18 years;
* consent of the patient or legal guardian to participate in the study;
* alcohol dependence syndrome (F10.2 according to ICD-10);
* history of depressive and anxiety symptoms;
* ability to understand and follow the therapist's instructions;
* functional ability of everyday life on the Barthel scale above 40 points.
Exclusion criteria:
* lack of consent to participate in the study;
* pregnancy;
* psychoactive substances other than alcohol;
* exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
* mental illnesses other than depression and anxiety disorders;
* psychotic diseases (F20- schizophrenia and other schizophrenic disorders);
* general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
* unstable or untreated epilepsy, based on EEG;
* active cancer disease;
* diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
* severe cognitive impairment;
* diagnosis of autism and ADHD;
* PTSD;
* intellectual disability (diagnosis F70 - F79);
* diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
Primary outcome measure(s)
- outcomes in patients suffering from schizophrenia requiring institutional care - MOCA or ACE-III — 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 — 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 — 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 — 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 — 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 — 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. — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Jerzy Kukuczka Academy of Physical Education in Katowice, Poland |
Katowice |
Silesian Voivodeship |
|
| Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland |
Rybnik |
Silesian Voivodeship |
|
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