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

Depression in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132061
• Other study ID #: 2023221
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Affiliated Hospital of Yunnan University
• Contact: Tan Tang, Ph.D.
• Phone: +86 139 2845 2325
• Email: ttang[@]ynu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder

Intervention

Other:
• universal prevention
Health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors.
• 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.
• targeted prevention
Therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms.
• Waiting treatment.
Waiting treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Yunnan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.