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AgingCAA+PGP#PWBNCT06841133

Chinese Art Activities or Combined With Peer Group Participation on Psychological Well Being

A study testing Chinese Art Activities and Chinese Art Activities combined with Peer Group Participation (PGP) in people with Aging, run by Prince of Songkla University at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this trial is to evaluate the effects of two interventions : routine care plus Chinese Art Activities(+CAA) and routine care plus Chinese Art Activities combined with Peer Group Participation (+CAA+PGP) on psychological well-being, loneliness, happiness, relaxation, and salivary cortisol levels in elderly… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Chinese Art Activities and Chinese Art Activities combined with Peer Group Participation (PGP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
3 sitesChina
Study dates
9 Jul 2025to 9 Aug 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 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 60-85 years.
  • Older persons living in Elderly Centers (ECs) for the first time, with a duration of stay ≤1 year.
  • Normal cognitive function (Mini-Mental State Examination [MMSE] score >24).
  • Possess necessary reading and writing skills.
  • Volunteer to participate in the study.

Who cannot join

  • Older persons with serious diseases (e.g., heart failure, asthma, cerebrovascular disease, advanced tumors).
  • Older persons who later leave the elderly center.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Praneed Songwathana contact

+66-081-5429170

praneed.s@psu.ac.th

China3 sites
  • Sukangyang · Gaoxin Yiyang

    Suzhou, Jiangsu, 215000

    rong shen, 086-13912773237, 641454262@qq.com

  • Sukangyang · Jiangling

    Suzhou, Jiangsu, 215000

    hua wang, 086-15862355350, 524073218@qq.com

  • Sukangyang · Yiyang

    Suzhou, Jiangsu, 215000

    hanying liu, 18061995200, 496408889@qq.com

Other trials in China

About this study

Official title: The Effectiveness of Chinese Art Activities Combined With Peer Group Participation on Psychological Well Being Among Newly Old Chinese of Elderly Center: Randomized Controlled Trail

The goal of this trial is to evaluate the effects of two interventions : routine care plus Chinese Art Activities(+CAA) and routine care plus Chinese Art Activities combined with Peer Group Participation (+CAA+PGP) on psychological well-being, loneliness, happiness, relaxation, and salivary cortisol levels in elderly participants (aged 60-85, new residents with ≤1 year of stay). The main questions it aims to answer are:

  • Does the +CAA intervention improve psychological well-being and related outcomes compared to routine care?
  • Does the +CAA+PGP intervention provide additional benefits over +CAA alone? Researchers will compare three groups (Group A: +CAA, Group B: +CAA +PGP, Group C: routine care) to see if the interventions lead to immediate and sustained improvements in the measured outcomes.
Read more

Participants will:

  • Undergo baseline assessments of psychological well-being(PWB), loneliness, happiness, relaxation, and salivary cortisol levels.
  • Receive their assigned intervention over three sessions within one week (Monday, Wednesday, Friday).
  • Complete outcome measures 30 minutes before and after each session.
  • Participate in a final follow-up assessment one week after the last session to evaluate sustained effects.
Read the detailed description

This multi-center, randomized, assessor-blind trial is designed based on the Max.-Min.-Con. principle, which aims to maximize the benefits of the intervention while minimizing potential confounding factors and ensuring control over the study design. The trial features three parallel intervention groups: control (routine care), +CAA, and +CAA+PGP, with a 1:1:1 allocation ratio. This balanced allocation ensures that each intervention group and the control group have an equal number of participants, allowing for a fair comparison of outcomes.

The study is conducted sequentially across three elderly centers, with each center serving as an independent randomization unit. This multi-center approach enhances the generalizability of the findings by including diverse populations from different locations. Within each institution, 30 participants (aged 60-85, new residents with ≤1 year of stay) are recruited through health providers, totaling 90 elderly participants across all three centers. The inclusion of new residents (with ≤1 year of stay) is critical, as this population is particularly vulnerable to stress and reduced psychological well-being (PWB) during the transition to elderly care centers.

To ensure balanced groups and control for confounding variables, minimized randomization is employed. Within each institution, the 30 participants are divided into three groups-Group A, Group B, and Group C-with 10 participants in each group. Group A receives the +CAA intervention, Group B receives the +CAA+PGP intervention, and Group C serves as the control group, receiving only routine care. The use of minimized randomization helps to balance key confounding factors such as age and visitation frequency, ensuring that the groups are comparable at baseline.

The intervention is delivered over three sessions within one week, specifically on day 1, day 3 and day 5. This schedule allows for consistent exposure to the interventions while providing adequate time for participants to rest between sessions. The +CAA intervention involves traditional Chinese art activities, such as calligraphy and painting, which are designed to promote relaxation and emotional well-being. The +CAA+PGP intervention** builds on this by incorporating peer group discussions, where participants share their experiences and artworks, fostering social interaction and mutual support.

Baseline assessments of key outcomes-psychological well-being (PWB), loneliness, happiness, relaxation, and salivary cortisol levels-are conducted prior to randomization. These baseline measures provide a reference point for evaluating the impact of the interventions. To capture the immediate effects of the interventions, outcome measures are collected 30 minutes before and after each intervention session. This allows the researchers to assess short-term changes in PWB, emotional states, and stress levels (as indicated by salivary cortisol).

Additionally, a final follow-up assessment is conducted one week after the last intervention session to evaluate the sustained outcomes of the interventions. This follow-up assessment is crucial for determining whether the benefits of the interventions persist beyond the immediate post-intervention period.

In summary, this trial is designed to rigorously evaluate the effectiveness of Chinese Art Activities (CAA) and their combination with Peer Group Participation (PGP) in improving psychological well-being and reducing stress among elderly residents transitioning to care centers. By employing a multicenter, randomized, and assessor-blind design, the study ensures robust and reliable results that can inform future interventions in elderly care settings.

Conditions
Aging
Being tested
Chinese Art Activities, Chinese Art Activities combined with Peer Group Participation (PGP)
Keywords
Art Activity, Peer Group, psychological well-being, older
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.

  • Chinese Art ActivitiesBehavioural

    This activity based on Recreation therapy, aims to heal the psychological symptom cluster and enhance the PWB of the old Chinese transit to the elderly center. The activity follows the usual care during the process with the addition of Chinese art activities. It employed the following two main activities:

    (1) Traditional Chinese landscape painting; (2) Calligraphy. The activity will be conducted 50min by researchers. It can be conducted at hall, conference room, etc. in the elderly center (EC), and it is a group intervention

  • Chinese Art Activities combined with Peer Group Participation (PGP)Behavioural

    The activity follows the usual care during the process with the addition of Chinese art activities combined with Peer Group Participation. The activity will be conducted 80min by researchers. In groups of 5 people, after the painting and calligraphy activity, under the organization of peers, each group member will show their works and talk about their feelings and views on their works. They will also share the reasons why they chose these words or sentences. Everyone must say words of comfort and encouragement to others' work.

Study groups in NCT06841133
Study groupRoleWhat they receive
Chinese Art Activities (CAA)ExperimentalParticipants will receive routine care plus the CAA intervention. The intervention is delivered over three sessions within one week (day1,3,5), with each session lasting 50 minutes.Baseline measures are collected pre-randomization. Outcomes are assessed 30 minutes before and after each intervention session . A final follow-up assessment is conducted one week after the last intervention.
Receives: Behavioral: Chinese Art Activities
Chinese Art Activities combined with Peer Group Participation (PGP)ExperimentalParticipants will receive routine care plus the CAA and PGP intervention. The intervention is delivered over three sessions within one week (day1,3,5), with each session lasting 80 minutes.Baseline measures are collected pre-randomization. Outcomes are assessed 30 minutes before and after each intervention session . A final follow-up assessment is conducted one week after the last intervention
Receives: Behavioral: Chinese Art Activities combined with Peer Group Participation (PGP)
routine careNo interventionParticipants in both the intervention and control groups will receive identical routine care, including daily activities such as simple limb exercises and group walks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Psychological Well-Being (PWB) Score at End of Intervention

    Psychological well-being was assessed using the 18-item Chinese version of Ryff's Psychological Well-Being Scale. This scale measures six dimensions of well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Each item is scored on a 6-point Likert scale (1=strongly disagree, 6=strongly agree). The total score ranges from 18 to 108, with higher scores indicating better psychological well-being.

    Measured: From enrollment to one week after the final intervention session

  2. Change From Baseline in Happiness Score at End of Intervention

    Happiness was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of happiness on a horizontal line, where 0 mm represents "not happy at all" and 100 mm represents "extremely happy." The VAS is a widely used tool for assessing subjective feelings, and higher scores indicate greater happiness.

    Measured: From enrollment to one week after the final intervention session

  3. Change From Baseline in Relaxation Score at End of Intervention

    Relaxation was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of relaxation on a horizontal line, where 0 mm represents "not relaxed at all" and 100 mm represents "extremely relaxed." The VAS is a validated tool for assessing subjective states, and higher scores indicate greater relaxation.

    Measured: From enrollment to one week after the final intervention session

  4. Change From Baseline in Loneliness Score at End of Intervention

    Loneliness was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of loneliness on a horizontal line, where 0 mm represents "extremely lonely" and 100 mm represents "not lonely at all." The VAS is a reliable tool for assessing subjective feelings, and higher scores indicate lower loneliness.

    Measured: From enrollment to one week after the final intervention session

  5. Change From Baseline in Salivary Cortisol Level at End of Intervention

    Salivary cortisol levels were measured as an indicator of stress response. Participants provided saliva samples, which were analyzed in a specialized laboratory using enzyme-linked immunosorbent assay (ELISA) techniques. Cortisol levels are reported in nmol/L, and higher values may indicate higher stress levels. This method is non-invasive and widely used in stress-related research.

    Measured: From enrollment to one week after the final intervention session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start9 Jul 2025 (estimated)
  3. Primary completion19 Jul 2025 (estimated)
  4. Study completion9 Aug 2025 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841133
Sponsor's protocol ID
PSU IRB 2024-St-Nur 048
Acronym
CAA+PGP#PWB
Status last verified
Feb 2025
First submitted
8 Feb 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The corresponding author's contact details will be publicly available for researchers to contact the investigators. Data are available upon written request, in accordance with the General Data Protection Regulation (GDPR)

Publications

  • Aydin M, Kutlu FY. The Effect of Group Art Therapy on Loneliness and Hopelessness Levels of Older Adults Living Alone: A Randomized Controlled Study. Florence Nightingale J Nurs. 2021 Oct;29(3):271-284. doi: 10.5152/FNJN.2021.20224.

    PubMed 35110167
  • Bourdon E, Belmin J. Enriched gardens improve cognition and independence of nursing home residents with dementia: a pilot controlled trial. Alzheimers Res Ther. 2021 Jun 16;13(1):116. doi: 10.1186/s13195-021-00849-w.

    PubMed 34134758
  • Ellis JM. Psychological transition into a residential care facility: older people's experiences. J Adv Nurs. 2010 May;66(5):1159-68. doi: 10.1111/j.1365-2648.2010.05280.x.

    PubMed 20423358
  • Hermann C. Bonsai as a group art therapy intervention among traumatized youth in KwaZulu-Natal. Psych J. 2021 Apr;10(2):177-186. doi: 10.1002/pchj.440. Epub 2021 Mar 9.

    PubMed 33751848
  • Koppitz AL, Dreizler J, Altherr J, Bosshard G, Naef R, Imhof L. Relocation experiences with unplanned admission to a nursing home: a qualitative study. Int Psychogeriatr. 2017 Mar;29(3):517-527. doi: 10.1017/S1041610216001964. Epub 2016 Nov 17.

    PubMed 27852339
  • Lan X, Xiao H, Chen Y. Life review for Chinese older adults in nursing homes: cultural acceptance and its effects. Int Psychogeriatr. 2019 Apr;31(4):527-535. doi: 10.1017/S1041610218001084. Epub 2018 Oct 2.

    PubMed 30277193
  • Mello S, O'Connor KA. Morbidity and Mortality Following Relocation of Highly Dependent Long-Term Care Residents: A Retrospective Analytical Study. J Gerontol Nurs. 2016 Nov 1;42(11):34-38. doi: 10.3928/00989134-20160908-01. Epub 2016 Oct 5.

    PubMed 27711930
  • Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13.

    PubMed 24417410
  • Sun C, Yu Y, Li X, Cui Y, Ding Y, Zhu S, Li X, Chen S, Zhou R. The factors of adaptation to nursing homes in mainland China: a cross-sectional study. BMC Geriatr. 2020 Nov 30;20(1):517. doi: 10.1186/s12877-020-01916-x.

    PubMed 33256628
  • Sun C, Zhou R, Cui Y, Ding Y, Li X, Li X, Zhang Y, Chen S, Xing Y. The Adaptation of Older Adults' Transition to Nursing Homes in Mainland China: A Qualitative Study. J Transcult Nurs. 2021 Jul;32(4):318-325. doi: 10.1177/1043659620923387. Epub 2020 May 23.

    PubMed 32449461
  • Wu CS, Rong JR. Relocation experiences of the elderly to a long-term care facility in Taiwan: a qualitative study. BMC Geriatr. 2020 Aug 6;20(1):280. doi: 10.1186/s12877-020-01679-5.

    PubMed 32762717
  • Pu L, Songwathana P. The Effectiveness of Art Activities and Peer Group Participation on Psychological Well-Being Among Older Adult Center Residents: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 29;15:e85612. doi: 10.2196/85612.

    PubMed 42214013

Questions about this trial

What is this clinical trial studying?

A study testing Chinese Art Activities and Chinese Art Activities combined with Peer Group Participation (PGP) in people with Aging, run by Prince of Songkla University at 3 sites in China.

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 5 inclusion and 2 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Liping Pu (086-13912773783, jsszplp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Psychological Well-Being (PWB) Score at End of Intervention (time frame: From enrollment to one week after the final intervention session). The study lists 5 primary outcomes in all. 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 NCT06841133, which also lists 12 linked publications.

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 3 Jul 2025.

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