Mental HealthNCT06763757
Art Therapy for Enhancing Well-Being in Solitary Older Adults
A study testing Art Therapy Program in people with Mental Health and Quality of Life, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Quality of Life, Emotional Well-being
- What is being tested?
- Art Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Art Application and Transformation on Solitary Seniors.
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.
Read the detailed description
This study explores the effects of art therapy on mental health and quality of life among solitary older adults. The research examines whether engaging in creative activities can reduce loneliness, enhance emotional well-being, and improve life satisfaction in this vulnerable population.
Living alone presents significant emotional and social challenges for older adults, increasing the risk of depression, isolation, and reduced quality of life. Art therapy, which combines creativity with emotional expression, offers a promising, non-invasive approach to address these issues. While its benefits are documented in other populations, its specific impact on solitary older adults is not fully understood. This study aims to provide evidence on how structured art therapy programs can support this group.
This study investigates the effects of art therapy on the mental health and quality of life of solitary older adults. Solitary living often increases the risk of depression, isolation, and reduced life satisfaction, making non-pharmacological interventions like art therapy a promising approach to address these challenges. This randomized controlled trial evaluates the feasibility and effectiveness of a structured art therapy program in enhancing psychological well-being and overall quality of life.
Participants will be randomly assigned to either the experimental group or the control group. The experimental group will attend 12 weekly art therapy sessions, each lasting 90 minutes. These sessions include hands-on art creation, discussions on art observation and interpretation, and reflective exercises to explore personal emotions and experiences. The program is designed to foster self-expression, enhance interpersonal connections, and promote emotional resilience. The control group will not receive any intervention and will continue their usual daily routines. Both groups will complete standardized assessments before and after the 12-week study period.
Evaluations will use 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 data collected will compare outcomes between the two groups to determine the impact of the art therapy intervention.
This study has been reviewed and approved by the Institutional Review Board (IRB) of the National Taiwan University Hospital Yunlin Branch. Written informed consent will be obtained from all participants, and their data will be securely stored and de-identified to ensure confidentiality. The findings aim to provide valuable insights into the use of art therapy as a scalable, non-pharmacological intervention for improving the mental health and quality of life of solitary older adults.
- Conditions
- Mental Health, Quality of Life, Emotional Well-being, Loneliness
- Being tested
- Art Therapy Program
- Keywords
- Occupational Therapy, Solitary Older Adults, Mental Health, Quality of Life, Art Therapy
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Therapy ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention).
Secondary outcomes (1)
Change in Depressive Symptoms (BDI)
The Beck Depression Inventory (BDI) is a self-reported questionnaire used to measure the severity of depressive symptoms. It consists of 21 items, each scored on a scale of 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms. The BDI is widely validated and commonly used in both clinical and research settings to assess changes in depression severity over time, making it ideal for evaluating the impact of interventions on mental health outcomes.
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763757
- Sponsor's protocol ID
- 202410001RINA
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41346530
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Application and Transformation on Solitary Seniors.
- ClinicalTrials.gov ID
- NCT06763757
- Acronym / sponsor ID
- 202410001RINA
- Conditions
- Mental Health, Quality of Life, Emotional Well-being, Loneliness
- Keywords
- Occupational Therapy, Solitary Older Adults, Mental Health, Quality of Life, Art Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Yunlin University of Science and Technology
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study explores the effects of art therapy on mental health and quality of life among solitary older adults. The research examines whether engaging in creative activities can reduce loneliness, enhance emotional well-being, and improve life satisfaction in this vulnerable population.
Living alone presents significant emotional and social challenges for older adults, increasing the risk of depression, isolation, and reduced quality of life. Art therapy, which combines creativity with emotional expression, offers a promising, non-invasive approach to address these issues. While its benefits are documented in other populations, its specific impact on solitary older adults is not fully understood. This study aims to provide evidence on how structured art therapy programs can support this group.
This study investigates the effects of art therapy on the mental health and quality of life of solitary older adults. Solitary living often increases the risk of depression, isolation, and reduced life satisfaction, making non-pharmacological interventions like art therapy a promising approach to address these challenges. This randomized controlled trial evaluates the feasibility and effectiveness of a structured art therapy program in enhancing psychological well-being and overall quality of life.
Participants will be randomly assigned to either the experimental group or the control group. The experimental group will attend 12 weekly art therapy sessions, each lasting 90 minutes. These sessions include hands-on art creation, discussions on art observation and interpretation, and reflective exercises to explore personal emotions and experiences. The program is designed to foster self-expression, enhance interpersonal connections, and promote emotional resilience. The control group will not receive any intervention and will continue their usual daily routines. Both groups will complete standardized assessments before and after the 12-week study period.
Evaluations will use 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 data collected will compare outcomes between the two groups to determine the impact of the art therapy intervention.
This study has been reviewed and approved by the Institutional Review Board (IRB) of the National Taiwan University Hospital Yunlin Branch. Written informed consent will be obtained from all participants, and their data will be securely stored and de-identified to ensure confidentiality. The findings aim to provide valuable insights into the use of art therapy as a scalable, non-pharmacological intervention for improving the mental health and quality of life of solitary older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy Intervention Group | Experimental | Behavioral: Art Therapy ProgramParticipants 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 |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Therapy ProgramThe 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. | Behavioural | Art Therapy Intervention Group |
Primary outcome
Change in Quality of Life (WHOQOL-BREF)
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention).
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.
1 secondary outcome
Change in Depressive Symptoms (BDI)
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 41346530Tsai 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy Program in people with Mental Health and Quality of Life, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIAO SHU-YI (+886-96380066, Y01843@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (WHOQOL-BREF) (time frame: Baseline (pre-intervention) and 12 weeks (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.