Depression Anxiety DisorderNCT07002385
A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
A study testing Intervention group in people with Depression Anxiety Disorder and Geriatric Diseases, run by Wenzhou Seventh People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression Anxiety Disorder, Geriatric Diseases, Mental Health and Quality of Life in Elderly Patients
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Primary psychiatric disorders:
- Schizophrenia or bipolar disorder
- Severe personality disorders
- Active suicidal ideation or psychotic symptoms
- Recent treatment history:
- Antipsychotic medication within 3 months
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression Anxiety Disorder, Geriatric Diseases, Mental Health and Quality of Life in Elderly Patients
- Being tested
- control group, Intervention group
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupBehavioural
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 groupCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | the control group received standard psychiatric care |
| intervention group | Experimental | The intervention group received a biopsychosocial integrated program Receives: Behavioral: control group; Combination Product: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 2 months, and 3 months post-intervention.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 2 months, and 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start12 Jan 2022
- Primary completion15 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Seventh People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yan Chen, Wenzhou Seventh People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002385
- Sponsor's protocol ID
- No. 20211115
- Status last verified
- Jan 2022
- First submitted
- 18 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
- ClinicalTrials.gov ID
- NCT07002385
- Acronym / sponsor ID
- No. 20211115
- Conditions
- Depression Anxiety Disorder, Geriatric Diseases, Mental Health and Quality of Life in Elderly Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Wenzhou Seventh People's HospitalOther government
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –the control group received standard psychiatric care |
| intervention group | Experimental | Behavioral: control group, Combination Product: Intervention groupThe intervention group received a biopsychosocial integrated program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- Schizophrenia or bipolar disorder
- Severe personality disorders
- Active suicidal ideation or psychotic symptoms
- Antipsychotic medication within 3 months
- Electroconvulsive therapy within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control groupThe 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. | Behavioural | intervention group |
| Intervention groupThe 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. | Combination product | intervention group |
Primary outcome
Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17)
Time frame: Baseline, 1 month, 2 months, and 3 months post-intervention.
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.
3 secondary outcomes
Mental Health Status (Profile of Mood States, POMS)
Time frame: Baseline, 1 month, 2 months, and 3 months post-intervention.
Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ)
Time frame: Baseline, 1 month, 2 months, and 3 months post-intervention.
Psychological Well-Being (Mental Health Continuum-Short Form, MHC-SF)
Time frame: Baseline, 1 month, 2 months, and 3 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Related trials for Depression Anxiety Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Depression Anxiety Disorder and Geriatric Diseases, run by Wenzhou Seventh People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17) (time frame: Baseline, 1 month, 2 months, and 3 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.