NCT06763757

Brief Summary

This study explores the impact of art therapy on mental health and quality of life among solitary older adults. Participants will be randomly assigned to one of two groups: an experimental group receiving art therapy sessions or a control group with no intervention. The art therapy program includes 12 weekly sessions lasting 90 minutes each, focusing on creative expression, observation of art, and reflective discussions. These activities are designed to enhance emotional well-being, reduce depressive symptoms, and foster interpersonal connections. Both groups will undergo evaluations before and after the 12-week study period. The assessments will include the Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) and the Beck Depression Inventory (BDI) to measure changes in psychological health and life satisfaction. The findings aim to demonstrate the feasibility and benefits of art therapy as a non-pharmacological intervention for improving the well-being of solitary older adults.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

December 27, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

24 days

First QC Date

December 27, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Occupational TherapySolitary Older AdultsMental HealthQuality of LifeArt Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life (WHOQOL-BREF)

    The primary outcome is the change in quality of life scores, as measured by the Taiwanese version of the WHO Quality of Life Questionnaire-BREF (WHOQOL-BREF). This tool evaluates quality of life across four domains: physical health, psychological well-being, social relationships, and environmental factors. Each domain is scored independently, with scores ranging from 0 to 100. Higher scores indicate better quality of life, reflecting positive perceptions in that domain.

    Baseline (pre-intervention) and 12 weeks (post-intervention).

Secondary Outcomes (1)

  • Change in Depressive Symptoms (BDI)

    Baseline (pre-intervention) and 12 weeks (post-intervention).

Study Arms (2)

Art Therapy Intervention Group

EXPERIMENTAL

Participants in the experimental group will attend 12 weekly art therapy sessions, each lasting 90 minutes. These sessions are designed to enhance emotional well-being, foster self-expression, and improve interpersonal connections through guided art activities. The program includes creating art, observing and discussing art pieces, and engaging in reflective exercises to explore personal emotions and experiences. Each session is structured to build upon the previous ones, beginning with activities to establish trust and comfort, progressing to deeper emotional exploration, and culminating in a final creative project. The sessions are led by trained facilitators and supervised by licensed occupational therapists. Evaluations will be conducted before and after the 12-week program using the Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) and the Beck Depression Inventory (BDI) to assess changes in mental health and quality of life

Behavioral: Art Therapy Program

No Intervention Control Group

NO INTERVENTION

Participants in the control group will not receive any intervention during the study period and will continue with their usual daily routines. They will complete two evaluations: one at baseline before the start of the study and another after 12 weeks. These evaluations will use the Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) and the Beck Depression Inventory (BDI) to measure mental health and quality of life. The data collected will serve as a comparison to determine the effectiveness of the art therapy intervention in the experimental group.

Interventions

The Art Therapy Program consists of 12 weekly group sessions, each lasting 90 minutes, designed to improve emotional well-being and quality of life in solitary older adults. Participants engage in structured activities that include creating art (e.g., drawing and painting), observing and interpreting art pieces, and reflective discussions to explore personal emotions and experiences. The sessions are led by trained facilitators under the supervision of licensed occupational therapists. This intervention follows a thematic progression: initial sessions focus on building trust and self-expression, mid-sessions deepen emotional awareness, and final sessions culminate in a creative project reflecting the participant's personal growth. Unlike other interventions, this program is tailored specifically for older adults living alone, addressing their unique challenges of isolation and reduced social interaction.

Art Therapy Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older.
  • Living alone.
  • Mini-Mental State Examination (MMSE) score between 24 and 30, indicating no significant cognitive impairment.
  • Capable of providing informed consent.
  • Physically able to participate in art-related activities such as drawing or painting.
  • Not currently undergoing psychiatric medication treatment for conditions such as depression, anxiety, schizophrenia, or bipolar disorder.

You may not qualify if:

  • Recent major life events (e.g., bereavement, severe illness) that could interfere with study participation.
  • History of brain injury or severe psychiatric conditions, such as schizophrenia or major depressive disorder requiring hospitalization.
  • Physical disabilities or motor impairments that prevent participation in art activities.
  • Participation in similar art therapy studies within the past 6 months.
  • Strong aversion or resistance to art therapy activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tsai PC, Chou WH, Liao SY. A randomized controlled trial study of a life review art intervention for older adults living alone. Front Psychol. 2025 Nov 19;16:1669119. doi: 10.3389/fpsyg.2025.1669119. eCollection 2025.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 8, 2025

Study Start

January 7, 2025

Primary Completion

January 31, 2025

Study Completion

May 31, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected during the study will be shared to support secondary research. This includes demographic data, baseline characteristics, and outcome measures (e.g., scores from the WHOQOL-BREF and Beck Depression Inventory). The shared data will exclude direct identifiers to ensure participant confidentiality.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The de-identified individual participant data (IPD) and supporting information will be available starting 6 months after the publication of the primary study findings. The data will remain accessible for a period of 5 years following the initial release.
Access Criteria
De-identified individual participant data (IPD) and supporting information, including the study protocol, statistical analysis plan, and informed consent form, will be accessible to qualified researchers who submit a formal data access request. The request must include a detailed research proposal outlining the intended use of the data, methods of analysis, and publication plans. Proposals will be reviewed and approved by the principal investigator and the Institutional Review Board (IRB) to ensure ethical and scientific validity. Approved researchers will be required to sign a data-sharing agreement to ensure compliance with data use policies. The data and documents will be shared through a secure external repository, with access granted on a case-by-case basis.