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A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases

W

Wenzhou Seventh People's Hospital

Status

Completed

Conditions

Mental Health and Quality of Life in Elderly Patients
Geriatric Diseases
Depression Anxiety Disorder

Treatments

Combination Product: Intervention group
Behavioral: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT07002385
No. 20211115

Details and patient eligibility

About

The biopsychosocial integrated intervention program is an effective model for improving holistic health in elderly patients with geriatric disease-related secondary depression, significantly alleviating depressive symptoms, enhancing mental health, and elevating quality of life.

Full description

To investigate the effects of a tripartite biopsychosocial intervention program on mental health and quality of life in elderly patients with depression secondary to geriatric diseases. A cluster randomized controlled trial was conducted with 166 elderly patients with secondary depression in our hospital between January 2022 and January 2025. Wards were randomized into an intervention group (n = 83) and a control group (n = 83) using SPSS-generated random sequences. The intervention group received a biopsychosocial integrated program, while the control group received standard psychiatric care. Outcomes were assessed at baseline, 1, 2, and 3 months post-intervention using the 17-item Hamilton Rating Scale for Depression (HAMD-17), mental health indicators [Profile of Mood States (POMS), Five Facet Mindfulness Questionnaire (FFMQ), and Mental Health Continuum-Short Form (MHC-SF)], and the Generic Quality of Life Inventory-74 (GQOLI-74). Patient satisfaction was evaluated post-intervention.

Enrollment

166 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of depression secondary to geriatric disease (ICD-10 criteria)

Age ≥60 years

Baseline HAMD-17 score ≥14 (mild depression or worse)

Mini-Mental State Examination (MMSE) score ≥24 (no significant cognitive impairment)

Willing and able to provide informed consent (patient or guardian)

Stable on current medications for ≥4 weeks prior to enrollment

Exclusion criteria

Primary psychiatric disorders:

Schizophrenia or bipolar disorder

Severe personality disorders

Active suicidal ideation or psychotic symptoms

Recent treatment history:

Antipsychotic medication within 3 months

Electroconvulsive therapy within 6 months

Participation in other interventional trials

Neurological conditions:

Alzheimer's disease or vascular dementia

Parkinson's disease with cognitive impairment

Brain tumors or traumatic brain injury

Medical comorbidities:

Terminal illness with life expectancy <6 months

Uncontrolled cardiovascular disease

Severe hepatic/renal insufficiency (GFR <30 mL/min)

Substance abuse disorders (alcohol or drugs within past year)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

166 participants in 2 patient groups

control group
No Intervention group
Description:
the control group received standard psychiatric care
intervention group
Experimental group
Description:
The intervention group received a biopsychosocial integrated program
Treatment:
Behavioral: control group
Combination Product: Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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