- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07669805
Social Prescribing for a Mindful Lifestyle
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sheng-Lun Kao, MD. PhD.
- Telefonnummer: 15599 +886-3-8561825
- E-post: stevenkao7434@gmail.com
Studiesteder
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Taiwan
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Hualien City, Taiwan, Taiwan, 97071
- Buddhist Tzu Chi General Hospital
-
Ta kontakt med:
- Sheng-Lun Kao, MD. PhD.
- Telefonnummer: 15599 +886-3-8561825
- E-post: stevenkao7434@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Eksperimentell arm
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Geriatric Depression Scale (GDS-15) score
Tidsramme: 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.
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Baseline and Week 8
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Changes in UCLA Loneliness Scale score
Tidsramme: 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.
|
Baseline and Week 8
|
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Changes in WHOQOL-BREF questionnaire score
Tidsramme: 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.
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Baseline and Week 8
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Sheng-Lun Kao, MD. PhD., Buddhist Tzu Chi General Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB115-107-A
Plan for individuelle deltakerdata (IPD)
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