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

Sponsor
Affiliated Hospital of Yunnan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06132061
Collaborator
(none)
500
4
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: universal prevention
  • Other: selective prevention
  • Other: targeted prevention
  • Other: Waiting treatment.
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group for universal prevention

Level 1 intervention (universal prevention) group

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

Experimental: Intervention group for selective prevention

Level 2 intervention(selective prevention) group

Other: 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.

Experimental: Intervention group for targeted prevention

Level 3 intervention(targeted prevention) group

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

Other: Control group

Other: Waiting treatment.
Waiting treatment.

Outcome Measures

Primary Outcome Measures

  1. Level of 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.]

    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.

Secondary Outcome Measures

  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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 100 Years
Sexes Eligible for Study:
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:
  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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Affiliated Hospital of Yunnan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tan Tang, Lecturer, Department of Social Work, Affiliated Hospital of Yunnan University
ClinicalTrials.gov Identifier:
NCT06132061
Other Study ID Numbers:
  • 2023221
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023