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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | the control group received standard psychiatric care | |
| intervention group | Experimental | The intervention group received a biopsychosocial integrated program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control group | Behavioral | The control group received standard psychiatric care, which involved physician-led management following clinical guidelines for geriatric disease treatment, including routine medication prescriptions based on diagnostic results. At diagnosis, healthcare providers informed caregivers about the confirmed disease entity, clinical status, and necessary precautionary measures. Monthly mental health lectures were conducted for all patients, covering topics such as common psychological symptoms and coping strategies. Post-discharge, monthly outpatient follow-ups included blood pressure and glucose monitoring. Medication dosages were adjusted if patients reported changes in somatic symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17) | The HAMD-17 is a 17-item clinician-administered scale assessing depressive symptom severity (range: 0-52). Higher scores indicate worse depression. Primary outcome: change in HAMD-17 scores from baseline to 3 months post-intervention. | Baseline, 1 month, 2 months, and 3 months post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Status (Profile of Mood States, POMS) | The POMS assesses mood disturbances across 40 items (score range: 0-200). Lower scores indicate better mood. | Baseline, 1 month, 2 months, and 3 months post-intervention. |
| Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Completed Mindfulness Sessions (Per Five Facet Mindfulness Questionnaire Guidelines | Proportion of attended mindfulness sessions (twice-weekly group sessions + daily APP-guided exercises) out of total prescribed sessions during the 3-month intervention. Adherence threshold: ≥70% (based on FFMQ therapeutic efficacy benchmarks). Data sourced from APP logs and clinician records. | Weekly monitoring over 3-month intervention. |
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenzhou Seventh People's Hospital | Wenzhou | Zhejiang | 325000 | China |
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| Intervention group | Combination Product | The intervention group received a structured biopsychosocial program delivered by a multidisciplinary team. Geriatricians adjusted medications biweekly; rehabilitation therapists led Baduanjin sessions and monitored daily exercises via smart wristbands. Nurses provided CBT-I manuals, and psychologists offered weekly video support. Psychological care included biweekly mindfulness sessions and daily app-guided exercises, with monthly life review activities. Social support involved community events, volunteer roles, and weekly caregiver workshops. Adherence (≥70%) was tracked via app; non-compliance triggered reminders and tailored support. Exercise intensity was regulated by heart rate; patients with ≥5-point HAMD-17 increases were referred. Monthly reviews ensured ongoing quality improvement. |
|
The FFMQ measures mindfulness across 5 facets (score range: 39-195). Higher scores reflect greater mindfulness. |
| Baseline, 1 month, 2 months, and 3 months post-intervention. |
| Psychological Well-Being (Mental Health Continuum-Short Form, MHC-SF) | The MHC-SF evaluates emotional, psychological, and social well-being (score range: 14-70). Higher scores denote better mental health. | Baseline, 1 month, 2 months, and 3 months post-intervention. |
| Average Weekly Baduanjin Exercise Duration (Minutes) Tracked via Smart Wristband | Total minutes of Baduanjin exercise per week, measured via smart wristband synchronization (target: 3×45-minute supervised sessions + 15-20 minutes daily home practice). Heart rate thresholds [(220 - age) × 0.6] ensured safety. | Weekly monitoring over 3-month intervention. |
| Number of Social Activities Attended (Community/Family Workshops) | Count of attended intergenerational activities (monthly) and family workshops (weekly) per participant. Categorized as: 0-25% (low), 26-75% (moderate), or 76-100% (high) of total offered activities. | Monthly tally over 3-month intervention. |
| Change in Morning Salivary Cortisol Concentration (nmol/L) | Diurnal cortisol slope measured at awakening (pre- and post-intervention). Collected via passive drool, assayed by ELISA. Reflects HPA axis regulation linked to depression severity. | Baseline and 3 months post-intervention. |
| Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Level (ng/mL) | Peripheral BDNF quantified via ELISA from venous blood samples. Explores neurobiological mechanisms of exercise/mindfulness interventions. | Baseline and 3 months post-intervention. |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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