跳至主要内容
临床试验/NCT07097675
NCT07097675尚未招募不适用

The Change in Psychoemotional State of Individuals With Dementia Syndrome Applying Art Therapy

Lithuanian University of Health Sciences0 个研究点目标入组 71 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
71
主要终点
Depression, Anxiety, and Stress Scales (DASS-21)

研究概览

简要总结

Due to global demographic changes, a notable trend of population aging has emerged, resulting in an increased prevalence of health conditions typically associated with the elderly. One such condition is cognitive impairment-dementia syndrome. Currently, 40,000 cases of dementia are registered in Lithuania (Health Information Centre), with projections estimating 81,000 cases by 2050 [13].

The care of individuals with dementia syndrome requires a holistic approach, incorporating both pharmacological and non-pharmacological interventions. The effectiveness of pharmacological treatment is limited: no highly effective drugs currently exist for Alzheimer's disease (available drugs have limited pathogenetic and symptomatic effects), there are no specific treatments for other forms of dementia, and the long-term use of medications to manage behavioral symptoms is associated with adverse effects. The OECD equates the routine use of neuroleptics with poor quality care [2]. Furthermore, even when medications are prescribed, non-pharmacological interventions should be applied concurrently [5].

One recommended method is arts therapy. Art therapy is a recognized psychosocial treatment that improves attention, perception, memory, and mood in people with dementia. However, there is a lack of studies evaluating the effectiveness of art therapy specifically in improving the psycho-emotional state of individuals with dementia syndrome.

Pharmacological treatments commonly used for dementia syndrome offer limited long-term benefits [23]. As the number of individuals affected by dementia continues to grow, increasing attention is being paid to improving their quality of life, social integration, and emotional well-being through non-pharmacological means. International guidelines recommend creative and artistic activities tailored to individual preferences, skills, and abilities, including music and dance [19]. One of the increasingly recognized interventions is art therapy [5]. Systematic review findings support the inclusion of various psychological interventions in the treatment of individuals with dementia who suffer from depression and/or anxiety disorders [3].

Globally, research most commonly explores the impact of art therapy on cognitive functions, quality of life, behavior, and psychological well-being in individuals with dementia [3; 4]. However, the FEATS scale is rarely used to assess emotional state changes. Although psycho-emotional issues are highly relevant and widely studied, relatively few studies explore these within the context of art therapy. Most existing research is qualitative, with a lack of quantitative studies.

The novelty of this planned study lies not only in the specificity of the participants but also in the application of the FEATS scale. While FEATS is widely used in research, few studies apply this instrument to explore the psycho-emotional state of people with dementia syndrome. The scale's authors and other researchers recommend expanding its use across diverse populations to assess its validity for different patient groups [10; 21].

This study will help reveal the effectiveness of art therapy as a non-invasive and non-pharmacological intervention for improving the psycho-emotional state of individuals with dementia syndrome. The research findings will contribute positively to patient well-being and the advancement of nursing science. Art therapy sessions are expected to improve participants' emotional state and reduce signs of anxiety, depression, and stress. This will provide scientific evidence of the effectiveness of art therapy and allow for the validation of the FEATS scale for assessing the psycho-emotional state of people with dementia syndrome.

详细描述

Research Aim To determine changes in the psycho-emotional state of individuals with dementia syndrome through the application of art therapy.

Research Objectives

  1. To assess the levels of anxiety, depression, and stress in individuals with dementia syndrome before and after art therapy.
  2. To evaluate changes in the formal elements of drawings made by individuals with dementia syndrome before and after art therapy.
  3. To analyze the relationships between changes in anxiety, depression, and stress levels and changes in the formal elements of drawings among individuals with dementia syndrome.
  4. To assess factors potentially associated with changes in anxiety, depression, and stress levels in individuals with dementia syndrome.

Instruments

  • For participant selection and assessment of cognitive functions: The Mini-Mental State Examination (MMSE); [7].
  • To determine levels of depression, anxiety, and stress before and after art therapy sessions: Lithuanian version of the Depression, Anxiety, and Stress Scales (DASS); [11].
  • To assess changes in the formal elements of drawings before and after art therapy sessions: Formal Elements Art Therapy Scale (FEATS); [10].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with dementia;
  • MMSE ≥11 (mild to moderate cognitive impairment);
  • stable somatic condition;
  • vision and hearing sufficient to assess cognitive function and to administer interventions;
  • familiar with the purpose and conduct of the study;
  • signed an informed consent form.

排除标准

  • MMSE < 11 points (severe cognitive impairment);
  • chronic, unstable somatic conditions;
  • Inability to comprehend the tasks;
  • Lack of knowledge of the Lithuanian language;
  • Refusal to take part in the study.

结局指标

主要结局

Depression, Anxiety, and Stress Scales (DASS-21)

时间窗: Baseline and after 6 weeks

The DASS-21 is intended to evaluate the severity of depression, anxiety, and stress. It consists of 21 statements divided into three subscales. Each subscale contains seven items grouped by similar content. The depression subscale measures dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The anxiety subscale assesses autonomic arousal, physiological responses, situational anxiety, and subjectively experienced anxiety. The stress subscale evaluates difficulty relaxing, nervous tension, sudden sadness, irritability, and excessive reactivity or impatience. The reliability of the Lithuanian version of the DASS-21 is sufficient, making it suitable for use with the Lithuanian population. Each item is scored from 0 (no symptom) to 3 (very strong expression of the symptom). Subscale scores are calculated by summing the scores of the respective items.

次要结局

  • Formal Elements Art Therapy Scale (FEATS)(Baseline and after 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aušra Sebeikaitė

PhD student, lecturer

Lithuanian University of Health Sciences

相似试验