NCT07669805

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are: To establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations. To evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population. Participants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

June 21, 2026

Last Update Submit

June 21, 2026

Conditions

Keywords

MindfulnessOlder AdultsLifestyle MedicineQuality of LifeSocial Prescribing

Outcome Measures

Primary Outcomes (3)

  • Changes in Geriatric Depression Scale (GDS-15) score

    The Geriatric Depression Scale (GDS-15) is a 15-item questionnaire used to assess depression symptoms in older adults. Scores range from 0 to 15, with higher scores indicating more severe depressive symptoms.

    Baseline and Week 8

  • Changes in UCLA Loneliness Scale score

    The UCLA Loneliness Scale measures an individual's subjective feelings of loneliness and social isolation. Scores range from 20 to 80, with higher scores indicating greater loneliness.

    Baseline and Week 8

  • Changes in WHOQOL-BREF questionnaire score

    The World Health Organization Quality of Life-BREF (WHOQOL-BREF) Taiwan version is a 28-item questionnaire used to assess the physical, psychological, social relationships, and environment domains of quality of life. Scores for each domain are transformed to a scale of 4 to 20, with higher scores indicating better quality of life. Changes in scores were evaluated between baseline and week 8.

    Baseline and Week 8

Study Arms (1)

Experimental Arm

EXPERIMENTAL
Behavioral: Mindfulness Lifestyle Social Prescribing Program

Interventions

An 8-week, once-weekly, 3-hour group program designed for middle-aged and older adults. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). It is delivered by a multidisciplinary team including geriatricians, case managers, dietitians, exercise instructors, and volunteers.

Experimental Arm

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People aged 55 years or older.
  • People with a Geriatric Depression Scale (GDS-15) score of 7-10 or a UCLA Loneliness Scale Version 3 score of 35-64.
  • People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the project.

You may not qualify if:

  • People that are unable to cooperate with the project or follow-up.
  • According to the PI's judgment, people with severe or poorly controlled conditions include ongoing acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
  • People with severe depression, risk of self-harm, severe cognitive impairment (dementia), visual or hearing impairment, and disabilities that prevent the completion of the project and assessment.
  • People are currently or expected to join any other physical training courses or nutrition intervention plans during the project period.
  • Others are based on the judgment of the PI that participating in this project may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97071, Taiwan

Location

Related Publications (3)

  • Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.

    PMID: 25910392BACKGROUND
  • Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.

    PMID: 20668659BACKGROUND
  • Paquet C, Whitehead J, Shah R, Adams AM, Dooley D, Spreng RN, Aunio AL, Dube L. Social Prescription Interventions Addressing Social Isolation and Loneliness in Older Adults: Meta-Review Integrating On-the-Ground Resources. J Med Internet Res. 2023 May 17;25:e40213. doi: 10.2196/40213.

    PMID: 37195738BACKGROUND

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Sheng-Lun Kao, MD. PhD.

    Buddhist Tzu Chi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Lun Kao, MD. PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations