NCT07097675

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

July 9, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

July 9, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

dementiaart therapydepressionanxietystress

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and after 6 weeks

Secondary Outcomes (1)

  • Formal Elements Art Therapy Scale (FEATS)

    Baseline and after 6 weeks

Study Arms (1)

Art Therapy

EXPERIMENTAL
Behavioral: Art Therapy

Interventions

Art TherapyBEHAVIORAL

Art Therapy Session Plan The sessions are designed to stimulate positive feelings, satisfaction, and calmness while reducing social isolation and fostering group connections. The focus will be on pleasant experiences and positive life moments, with an emphasis on identifying current strengths and capabilities. Every session begins with a sharing activity: "Name three good things that happened this morning" or "Name three things you are grateful for today." Session Structure: Mood check-in → Warm-up task → Main task → Reflection → Mood check-out.

Art Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Norkiene I, Jovarauskaite L, Kvedaraite M, Uppal E, Phull MK, Chander H, Halford K, Kazlauskas E. 'Should I Stay, or Should I Go?' Psychological Distress Predicts Career Change Ideation among Intensive Care Staff in Lithuania and the UK Amid COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Mar 6;18(5):2660. doi: 10.3390/ijerph18052660.

    PMID: 33800903BACKGROUND
  • 1. Bikulčius, R. (2014). Application of scales and tests in assessing the physical, mental, and functional condition of the elderly. Gerontology, 15(1), 54-63.

    BACKGROUND
  • 2. de Bienassis, K., Llena-Nozal, A., & Klazinga, N. S. (2020). The economics of patient safety Part III: Long-term care: Valuing safety for the long haul.

    BACKGROUND

MeSH Terms

Conditions

DementiaDepressionAnxiety Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Aušra Sebeikaitė, master

CONTACT

Jūratė Macijauskienė, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, lecturer

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 31, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share