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

NCT07002385 | Completed

• 1 other identifier: No. 20211115
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mental Health Status (Profile of Mood States, POMS)

  Baseline, 1 month, 2 months, and 3 months post-intervention.

• Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ)

  Baseline, 1 month, 2 months, and 3 months post-intervention.

• Psychological Well-Being (Mental Health Continuum-Short Form, MHC-SF)

  Baseline, 1 month, 2 months, and 3 months post-intervention.

Other Outcomes (5)

• Percentage of Completed Mindfulness Sessions (Per Five Facet Mindfulness Questionnaire Guidelines

  Weekly monitoring over 3-month intervention.

• Average Weekly Baduanjin Exercise Duration (Minutes) Tracked via Smart Wristband

  Weekly monitoring over 3-month intervention.

• Number of Social Activities Attended (Community/Family Workshops)

  Monthly tally over 3-month intervention.

Study Arms (2)

control group

NO INTERVENTION

the control group received standard psychiatric care

intervention group

EXPERIMENTAL

The intervention group received a biopsychosocial integrated program

Behavioral: control group; Combination Product: Intervention group

Interventions

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.

intervention group

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.

intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenzhou Seventh People's Hospital: lead

Study Sites (1)

Wenzhou Seventh People's Hospital

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 3, 2025
• Study Start: January 12, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 26, 2025
• Last Updated: June 3, 2025

Record last verified: 2022-01

Locations

CN (1)