Depression and/or Anxiety in the Mild-to-moderate RangeNCT07669805
Social Prescribing for a Mindful Lifestyle
A study testing Mindfulness Lifestyle Social Prescribing Program in people with Depression and/or Anxiety in the Mild-to-moderate Range and Loneliness, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness, Social Isolation
- What is being tested?
- Mindfulness Lifestyle Social Prescribing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2026to 31 Dec 2028
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 97071
Sheng-Lun Kao, MD. PhD., +886-3-8561825 ext. 15599, stevenkao7434@gmail.com
About this study
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.
Read more
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.
Read the detailed description
This clinical trial implements an 8-week mindfulness lifestyle social prescribing program designed to enhance the psychological and social well-being of community-dwelling older adults. The intervention integrates mindfulness practices with healthy lifestyle modifications to address sub-healthy states, such as depressive symptoms and social isolation, which traditional clinical models often fail to fully resolve.
The structured 8-week group curriculum meets weekly for 3 hours per session. The program systematically incorporates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (including herbal therapy and leaf printing).
The program is delivered by a multidisciplinary team of geriatricians, geriatric case managers, nutritionists, exercise instructors, and trained volunteers to ensure comprehensive support.
Research procedures involve a pre- and post-intervention assessment design. Participants will undergo standardized evaluations before the commencement of the first session (Week 1) and upon the completion of the program (Week 8). These assessments will objectively measure changes in depressive symptoms, the risk of loneliness, and overall quality of life to determine the effect of this social prescribing model.
- Being tested
- Mindfulness Lifestyle Social Prescribing Program
- Keywords
- Mindfulness, Older Adults, Lifestyle Medicine, Quality of Life, Social Prescribing
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Lifestyle Social Prescribing ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Behavioral: Mindfulness Lifestyle Social Prescribing Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start9 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression and/or Anxiety in the Mild-to-moderate RangeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Lun Kao, MD. PhD., Principal investigator, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669805
- Sponsor's protocol ID
- IRB115-107-A
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25910392Holt-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.
PubMed 20668659Paquet 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.
PubMed 37195738
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Prescribing for a Mindful Lifestyle
- ClinicalTrials.gov ID
- NCT07669805
- Acronym / sponsor ID
- IRB115-107-A
- Keywords
- Mindfulness, Older Adults, Lifestyle Medicine, Quality of Life, Social Prescribing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (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.
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.
Detailed description
This clinical trial implements an 8-week mindfulness lifestyle social prescribing program designed to enhance the psychological and social well-being of community-dwelling older adults. The intervention integrates mindfulness practices with healthy lifestyle modifications to address sub-healthy states, such as depressive symptoms and social isolation, which traditional clinical models often fail to fully resolve.
The structured 8-week group curriculum meets weekly for 3 hours per session. The program systematically incorporates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (including herbal therapy and leaf printing).
The program is delivered by a multidisciplinary team of geriatricians, geriatric case managers, nutritionists, exercise instructors, and trained volunteers to ensure comprehensive support.
Research procedures involve a pre- and post-intervention assessment design. Participants will undergo standardized evaluations before the commencement of the first session (Week 1) and upon the completion of the program (Week 8). These assessments will objectively measure changes in depressive symptoms, the risk of loneliness, and overall quality of life to determine the effect of this social prescribing model.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Mindfulness Lifestyle Social Prescribing Program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Mindfulness Lifestyle Social Prescribing ProgramAn 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. | Behavioural | Experimental Arm |
Primary outcome
Changes in Geriatric Depression Scale (GDS-15) score
Time frame: Baseline and Week 8
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.
Changes in UCLA Loneliness Scale score
Time frame: Baseline and Week 8
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.
Changes in WHOQOL-BREF questionnaire score
Time frame: Baseline and Week 8
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.
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 2 Oct 2026.
- Background: PubMed 25910392Holt-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.
- Background: PubMed 20668659Holt-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.
- Background: PubMed 37195738Paquet 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.
- Individual participant dataSharing planned: No
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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.
Sheng-Lun Kao, MD. PhD. principal investigator
Buddhist Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Lifestyle Social Prescribing Program in people with Depression and/or Anxiety in the Mild-to-moderate Range and Loneliness, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Sheng-Lun Kao, MD. PhD. (+886-3-8561825 ext. 15599, stevenkao7434@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Geriatric Depression Scale (GDS-15) score (time frame: Baseline and Week 8). The study lists 3 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 NCT07669805, which also lists 3 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 2 Oct 2026.