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Набор скоро начнётся NCT07748078

Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia

Без фазы С лечением SCHIZOPHRENIA 1 (Disorder) Alcohol Use Disorder Alcohol Dependence (Primary Condition)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Snoezelen® therapy for 6 weeks, Snoezelen® therapy for 12 weeks.
Кому может быть актуально
Состояния в реестре: SCHIZOPHRENIA 1 (Disorder), Alcohol Use Disorder, Alcohol Dependence (Primary Condition). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

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

Критерии участия

  • Adults suffering from schizophrenia requiring permanent institutional care, N=40

Критерии включения

  • 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,

Критерии исключения

  • 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

Критерии включения

  • 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,

Критерии исключения

  • 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

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Польша · 2 центра
  • Jerzy Kukuczka Academy of Physical Education in Katowice, Poland — Katowice
  • Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland — Rybnik

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗