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

• ClinicalTrials.gov Identifier: NCT06132061
• Recruitment Status: Not yet recruiting
• First Posted: November 15, 2023
• Last Update Posted: November 15, 2023
• Sponsor: Affiliated Hospital of Yunnan University
• Information provided by (Responsible Party): Tan Tang, Affiliated Hospital of Yunnan University

Tracking Information

• First Submitted Date: November 6, 2023
• First Posted Date: November 15, 2023
• Last Update Posted Date: November 15, 2023
• Estimated Study Start Date: December 1, 2023
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2023)

Level of 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. ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 9, 2023)

Psychological flexibility [ 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. ]

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community
• Official Title: Research on Three-level Prevention and Intervention for Elderly Depression in Urban Community

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Depression in Old Age

Intervention

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

Study Arms

• Experimental: Intervention group for universal prevention
  Level 1 intervention (universal prevention) group
  Intervention: Other: universal prevention
• Experimental: Intervention group for selective prevention
  Level 2 intervention(selective prevention) group
  Intervention: Other: selective prevention
• Experimental: Intervention group for targeted prevention
  Level 3 intervention(targeted prevention) group
  Intervention: Other: targeted prevention
• Control group
  Intervention: Other: Waiting treatment.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 9, 2023): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tan Tang, Ph.D.; +86 139 2845 2325; ttang@ynu.edu.cn

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06132061
• Other Study ID Numbers: 2023221
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Tan Tang, Affiliated Hospital of Yunnan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Affiliated Hospital of Yunnan University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Affiliated Hospital of Yunnan University
• Verification Date: November 2023