Clinical trial NCT07002385: A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
Official title: A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Anxiety Disorder
Geriatric Diseases
Mental Health and Quality of Life in Elderly Patients
Lead sponsor: Wenzhou Seventh People's Hospital
Sponsor class: OTHER_GOV
First posted: 2025-06-03
Enrollment: 166
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17)
timeFrame: Baseline, 1 month, 2 months, and 3 months post-intervention.
Secondary outcomes:
measure: Mental Health Status (Profile of Mood States, POMS)
timeFrame: Baseline, 1 month, 2 months, and 3 months post-intervention.
measure: Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ)
timeFrame: Baseline, 1 month, 2 months, and 3 months post-intervention.
measure: Psychological Well-Being (Mental Health Continuum-Short Form, MHC-SF)
timeFrame: Baseline, 1 month, 2 months, and 3 months post-intervention.
Other outcomes:
measure: Percentage of Completed Mindfulness Sessions (Per Five Facet Mindfulness Questionnaire Guidelines
timeFrame: Weekly monitoring over 3-month intervention.
measure: Average Weekly Baduanjin Exercise Duration (Minutes) Tracked via Smart Wristband
timeFrame: Weekly monitoring over 3-month intervention.
measure: Number of Social Activities Attended (Community/Family Workshops)
timeFrame: Monthly tally over 3-month intervention.
measure: Change in Morning Salivary Cortisol Concentration (nmol/L)
timeFrame: Baseline and 3 months post-intervention.
measure: Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Level (ng/mL)
timeFrame: Baseline and 3 months post-intervention.
Locations:
city: Wenzhou
country: China
facility: Wenzhou Seventh People's Hospital
state: Zhejiang
Study officials:
References: