Research Aim To determine changes in the psycho-emotional state of individuals with dementia syndrome through the application of art therapy.
Research Objectives
- To assess the levels of anxiety, depression, and stress in individuals with dementia syndrome before and after art therapy.
- To evaluate changes in the formal elements of drawings made by individuals with dementia syndrome before and after art therapy.
- 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.
- 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].
Sample Size and Justification:
71 participants. The sample size was calculated based on 2022 data from the Lithuanian Health Information Centre.
Study Design and Stages
The following data will be collected from medical records:
- Clinical Data: Primary diagnosis, date of dementia diagnosis, comorbidities, MMSE scores.
- Demographic Data: Gender, age, place of residence, education, occupation, marital status, living situation, and social connections.
The interventions used in this study are not listed in the Lithuanian Ministry of Health's Order No. V-1483 of December 31, 2014, which defines biomedical research methods causing minor and temporary adverse effects on participant health.
Planned Duration and Frequency of Visits Groups of 5-6 participants will meet twice a week for seven weeks.
- First Meeting: Completion of DASS-21 scale and drawing titled "Pick an Apple from the Tree."
- Second to Thirteenth Meetings: Twelve 80-minute art therapy sessions aimed at stimulating positive emotions, enhancing satisfaction and relaxation, and establishing connections with group members. Focus will be placed on pleasant experiences and moments in life, as well as discovering current strengths and abilities. Each session will follow this structure: mood check-in, warm-up task, main task, reflection, mood check-out.
- Fourteenth Meeting: Re-completion of the DASS-21 scale and repeating the drawing "Pick an Apple from the Tree."
Selection of Study Participants and Instruments Used To select study participants, the Mini-Mental State Examination (MMSE); [7] will be used-a short, quick, and easy-to-administer tool that quantitatively assesses cognitive functions [7; 16]. This instrument is widely used in clinical practice and scientific research. Its sensitivity ranges from 0.71 to 0.87 and specificity from 0.81 to 0.96 [15; 1].
The MMSE consists of 11 questions and tasks that analyze seven cognitive domains: orientation in time and space, memorization of three words, attention and calculation, recall of three words, language, and ability to follow simple verbal and written commands. The administration takes approximately 5-10 minutes. For each correct answer or correctly completed task, points are awarded. The fewer the points scored, the more severe the cognitive impairment. The maximum score is 30. A score of ≥25 indicates no cognitive impairment, 20-24 indicates mild impairment, 11-19 indicates moderate impairment, and 0-10 indicates severe cognitive impairment [1].
To assess the psycho-emotional state of the participants, two instruments will be used: the DASS-21 and the FEATS scales, each measuring psycho-emotional states through different approaches.
All instruments are valid, freely available, and do not require author permission for use.
To conduct the study, the following data will be collected:
- Clinical and demographic data from participants (e.g., main diagnosis, date of dementia diagnosis, comorbid conditions, MMSE results, gender, age, place of residence, education, profession, marital status, living situation, and social connections). These data will be recorded using a paper protocol.
- DASS-21 results before and after art therapy sessions, via paper questionnaires.
- Drawings based on the theme "Person Picking an Apple from a Tree."
- Visual expression products created by participants during art therapy sessions. All test and scale data will be evaluated strictly according to methodological guidelines. The collected data will undergo statistical analysis.
The study will be conducted at the Nursing Clinic of Kaunas Clinics of Lithuanian University of Helth Sciences and the Kazys Grinius Nursing and Supportive Treatment Hospital. These institutions were chosen due to enough participants from the target group and because the length of stay of dementia patients allows for the implementation of the planned art therapy intervention.
Field Notes During and after the art therapy sessions, field notes will be kept documenting the study process. These notes will include the researcher's observations, thoughts, questions, and any changes in participants' health status.
Withdrawal from the Study Participants may voluntarily withdraw from the study at any time. No written request will be required. Participation will also be suspended if the researcher or medical staff observes any deterioration in the participant's health.
Recruitment Process The researcher will personally invite patients being treated in the departments and will also work with department staff. Additionally, an invitation poster will be displayed in the department, including the researcher's contact number for those interested.
Informed Consent Procedures Patients at the study sites will receive educational information about art therapy and its potential benefits. Those wishing to participate will be asked to sign an informed consent form. Before beginning, patients whose MMSE score is ≥11 (indicating no severe cognitive impairment) and who are not suffering from unstable chronic somatic illnesses will be selected. Participants must speak Lithuanian to engage in therapy reflections. Individuals meeting these criteria will be invited to participate. Each participant will be informed about the study process, session schedule, and duration.
Potential Benefits Art therapy sessions are expected to evoke positive emotions in participants. They may experience satisfaction, relaxation, and opportunities to form bonds with other group members. This is expected to improve their psycho-emotional state and reduce symptoms of depression, anxiety, and stress.
Potential Risks and Inconveniences Participants may perceive filling out sociodemographic questionnaires and attending art therapy sessions as time-consuming. Traveling to the study site may disrupt daily routines. Sharing personal experiences during therapy reflections may also cause emotional discomfort.
Documentation and Evaluation of Adverse Events
An adverse event is defined as:
- Sudden deterioration in a participant's health during a session.
- Significant psychological discomfort.
- Conflict between the participant and the researcher. If a participant's health worsens during a session, staff at the study site will be called for assistance, and the session will be stopped. All adverse events will be documented in field notes, including the date, researcher involved, description, response, and decisions made.
Data Protection and Confidentiality
The collected data include:
- From medical records: clinical (diagnosis, dementia diagnosis date, comorbidities, MMSE results) and demographic (gender, age, residence, education, profession, marital status, living situation, social ties).
- From participants: DASS-21 results before and after therapy, drawings, and all visual art created during sessions.
All data will be pseudonymized using letter and number codes. If necessary, identifiable data will only be accessible to authorized monitors, ethics committees, or supervising institutions. Coded health data will be available only to the main researchers. Paper questionnaires will be assigned four-digit codes, stored in locked cabinets at the study site, and data will be entered into a OneDrive folder provided by the university and analyzed using SPSS. Access will be password-protected and known only to researchers.
Paper forms, DASS-21 data, and drawings will be stored for 10 years post-study for academic or ethical review, retrospective studies, or dispute prevention. Original data will be destroyed following institutional policy.
If needed, data may be shared with authorized persons, ethics committees, or other supervising institutions. Drawings created during therapy will be returned to participants or their relatives upon request.
De-identified data (study results) will be used in scientific publications and conference presentations.
Participants may withdraw consent at any time before the anonymization of their data. Identifiable data linking participants to their codes will be destroyed immediately after the study ends.
