A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
NCT ID: NCT07002385
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2022-01-12
2025-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control group
the control group received standard psychiatric care
No interventions assigned to this group
intervention group
The intervention group received a biopsychosocial integrated program
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion 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
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)
60 Years
ALL
No
Sponsors
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Wenzhou Seventh People's Hospital
OTHER_GOV
Responsible Party
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Yan Chen
Principal Investigator
Locations
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Wenzhou Seventh People's Hospital
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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No. 20211115
Identifier Type: -
Identifier Source: org_study_id
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