NCT06132061

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 6, 2023

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

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.

    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

    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.

Study Arms (4)

Intervention group for universal prevention

EXPERIMENTAL

Level 1 intervention (universal prevention) group

Other: universal prevention

Intervention group for selective prevention

EXPERIMENTAL

Level 2 intervention(selective prevention) group

Other: selective prevention

Intervention group for targeted prevention

EXPERIMENTAL

Level 3 intervention(targeted prevention) group

Other: targeted prevention

Control group

OTHER
Other: Waiting treatment.

Interventions

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.

Intervention group for selective prevention

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

Intervention group for universal prevention

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

Intervention group for targeted prevention

Waiting treatment.

Control group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Street

Kunming, Yunnan, 650000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Social Work

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 15, 2023

Study Start

July 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 10, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations