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CompletedNCT06132061Updated Dec 10, 2025

Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community

An interventional study of universal prevention and selective prevention in Depression in Old Age, sponsored by Affiliated Hospital of Yunnan University. Completed at 1 site in China. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Affiliated Hospital of Yunnan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
327
Allocation
Randomized
Ages
60 Years to 100 Years
Sex
All
01

Study summary

The goal of this clinical trial is to compare the effect of three level interventions(universal prevention, selective prevention and targeted prevention) in elderly depression and find out the most efficient intervention path. The main questions it aims to answer are:

  • Whether the pre-disease three-level prevention model (universal prevention, selective prevention and targeted prevention) is applicable for elderly depression in urban communities;
  • Which level of intervention has the best effect on elderly depression.

Participants will be given the following treatments:

  • Level 1 intervention(universal prevention): Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.
  • Level 2 intervention(selective prevention): Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms.
  • Level 3 intervention(targeted prevention): Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.

Researchers will compare control group to see if the three levels of intervention have a significant effect.

02

Conditions studied

  • Depression in Old Age
03

In context

Lead sponsor

Affiliated Hospital of Yunnan University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 60 and above;
  2. Permanent residents of urban communities in China;
  3. Geriatric Depression Scale (GDS-15) \< 9 points;
  4. There are susceptibility factors such as living alone, poverty, and suffering from serious diseases.

Exclusion criteria

Exclusion Criteria:

  1. There is suicidal behavior or risk;
  2. A history of any other mental illness, including drug or alcohol dependence;
  3. Those who have speech and hearing disorder and cannot communicate normally;
  4. Geriatric Depression Scale (GDS-15) ≥10 points;
  5. Do not agree to participate in the research.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
327 participants (actual)

Study arms

  • Experimental
    Intervention group for universal prevention

    Level 1 intervention (universal prevention) group

    Other: universal prevention

  • Experimental
    Intervention group for selective prevention

    Level 2 intervention(selective prevention) group

    Other: selective prevention

  • Experimental
    Intervention group for targeted prevention

    Level 3 intervention(targeted prevention) group

    Other: targeted prevention

  • Other
    Control group

    Other: Waiting treatment.

Interventions

  • Otheruniversal prevention

    Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.

  • Otherselective prevention

    Psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms.

  • Othertargeted prevention

    Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.

  • OtherWaiting treatment.

    Waiting treatment.

06

What researchers measure

Primary outcomes

  1. Level of depression

    A simplified version of Geriatric Depression Scale(GDS-15) will be used to mesure the level of depression. The scale has 15 items and asks the elderly to answer "yes" or "no" based on how they have felt in the past week. The "yes" is 1 point, "no" is 0 points. The higher the score indicates the more obvious depressive symptoms. The total score is 15 points. 0-4 points indicate no depression, 5-9 points indicate mild depression, and 10-15 points indicate moderate to severe depression.

    Time frame: Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.

Secondary outcomes

  1. Psychological flexibility

    Psychological flexibility refers to an individual's ability to be open and flexible to his or her own experiences, thoughts or feelings, which can prompt him or her to take action or make changes when engaged in difficult events. Psychological flexibility can be measured by the simplified Multidimensional Psychological Flexibility Inventory(MPFI-24). The scale consists of 24 items and is divided into two subscales: psychological flexibility (PF) and psychological inflexibility (PI). Each items is rated by the subject on a 6-point Likert scale (1=never to 6=always). Higher subscale scores were associated with higher levels of psychological flexibility or psychological inflexibility.

    Time frame: Measurements were taken at baseline, after intervention(3 months after baseline) and 6 months after intervention.The data will be reported through study completion, an average of 1 year.

07

Study locations

1 site
  • Huashan Street
    Kunming, Yunnan 650000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06132061
Lead sponsor
Affiliated Hospital of Yunnan University
Responsible party
Tan Tang (Lecturer, Department of Social Work, Affiliated Hospital of Yunnan University) — Principal investigator
First posted
Nov 15, 2023
Start date
Jul 1, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Dec 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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