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

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.

Study Overview

• Status: Completed
• Conditions: Geriatric Diseases; Depression Anxiety Disorder; Mental Health and Quality of Life in Elderly Patients
• Intervention / Treatment: Behavioral: control group; Combination product: Intervention group

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.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Seventh People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; the control group received standard psychiatric care
Experimental: intervention group; The intervention group received a biopsychosocial integrated program	Behavioral: control group; 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.; Combination product: Intervention group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Other Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Wenzhou Seventh People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 26, 2025

Study Registration Dates

• First Submitted: May 18, 2025
• First Submitted That Met QC Criteria: May 24, 2025
• First Posted (Actual): June 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 24, 2025
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: No. 20211115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No