Community-based Rehabilitation Management for Patients With Remitted Geriatric Depression

Duan Li

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Geriatric Depression

Treatments: Combination Product: TAR(treatment as routine); Combination Product: CBRM (community-based rehabilitation management)

Study type: Interventional

Funder types: Other

Identifiers

NCT05610917

ChengdeMU

Details and patient eligibility

About

This study intends to take patients with RGD as objects. Further construct a community-based rehabilitation management (CBRM) program with drug treatment, rehabilitation measures of education, psychology and exercise as its core content on the basis of evidence-based practice approach. Based on the cost-utility analysis of health economics, the health and economic benefits of the CBRM program will be evaluated, and a theoretical reference will be provided for community health institutions to carry out whole-course rehabilitation management practice and health policy formulation.

Full description

Based on the background of population aging, the prevalence of Late life depression tends to increase, and the recurrence rate after antidepressants treatment is still as high as 35%-57%, and the disease course tends to be chronic. Therefore, the formulation and implementation of prevention and control programs have become a significant part of the government's work plan. Physical frailty symptoms such as loss of daily activities and weakness are common in patients with remitted geriatric depression (RGD), and cognitive impairment is also considered to be an independent persistent symptom of RGD patients, which are related to the fluctuation and recurrence of depressive symptoms in elderly patients. Physical cognitive decline syndrome (PCDS) can comprehensively assess the physical frailty symptoms and the degree of cognitive impairment of the elderly, and effectively predict the course of the disease and the trend of healthy development. However, studies applied to the field of emotional disorder have not been retrieved. Therefore, this study intends to take patients with RGD as objects to investigate the prevalence of PCDS, build a risk prediction model and reveal it is warning mechanisms. That is, after determinning the basis of risk factors affecting the occurence of PCDS in RGD patients, we will carry out the formulation, implementation and evaluation of the follow-up CBRM program.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 60 years old or above at the time of enrollment;
• meet the diagnostic criteria for MDD without psychotic features according to DSM-5, and depressive symptoms have been improved and remained stable for at least 2 months after treatment with SSRIs;
• the total score of HAMD-17 is less than 7 at the time of enrollment;
• meet the diagnostic criteria for physio-cognitive decline: 1) the total score of ADL and IADL was less than 26; 2)cognitve decline: first, subjects with severe impairment of cognitive function will be excluded (years of education ≥ 6, MMSE scores <24；years of education <6 years, MMSE total score <14). After completing a neuropsychological task, cogintive declined will be confirmed when any aspects of cognitve function is 1.5 standard deviations lower than that of normal elderly; 3) the grip strength is weakened, and the domaint hand grip strength is < 28kg for males or <18kg for females; 4)slow step speed, that is, in a space of length >10 meters, the subjects walks 6 meters from the starting point at a normal and uniform pace, and the pace is <1m/s.
• comprehension, reading and writing skills to complete the measurements or complete them with assistance of the researchers with obstacles;
• voluntary participation and signed informed consent.

Exclusion criteria

• meet the diagnostic of schizophrenia, bipolar disorder, dementia;
• comorbidity of physical diseases, such ascardiovascular and cerebrovascular diseases, rheumatoid arthritis, stroke and malignant tumors;
• history of alcohol or drug dependence;
• severe deformity of spine and limbs;
• complete or partial dependence on caregivers for daily life, such as long-term bedridden, wheelchair assisted;
• have received physical therapy or psychological treatment in the past three months;
• currently participating in other clinical research.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

case group,

Experimental group

Description:

Patients in case group will be treated with CBRM program

Treatment:

Combination Product: CBRM (community-based rehabilitation management)

control group

Other group

Description:

the control group patients will be treated routinely as usual.

Treatment:

Combination Product: TAR(treatment as routine)