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Clinical Trials in China / NCT07180342
Recruiting Not applicable

An Empirical Study on the Mechanisms of Biopsychosocial Functional Improvement in Patients With Major Depressive Disorder Through Nature-Based Tourism Activities

NCT07180342 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Provincial Hospital
Phase
Not applicable
Started
2025-10-09
Last updated
2025-12-16

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Tourism-based intervention

Tourism-based intervention: Following the acquisition of participant consent and the signing of (electronic) informed consent forms, subjects were randomized into either an intervention group or a control group using a computer-generated randomization list. The intervention group received a tourism-based intervention, while the control group continued to receive usual care without any structured modifications to their daily living patterns or treatment plans. Both groups maintained a foundational treatment regimen of antidepressant medication.

Study summary

Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.

Eligibility

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily participate in the study and sign the informed consent form; 2. Age between 18 (inclusive) and 60 (exclusive) at the screening period; 3. Meet the DSM-5 diagnostic criteria for a Major Depressive Episode (MDE) at enrollment, based on medical records, clinical assessment, and the Mini-International Neuropsychiatric Interview (MINI version 7.0.2); 4. Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17 at both screening and baseline; 5. Physically stable based on medical history and vital signs (including blood pressure); 6. Deemed by the investigator to be capable of independently completing all assessment tools required by the study protocol and willing to comply with the trial procedures throughout the study period. Exclusion Criteria: 1. Current or past diagnosis of: schizophrenia, psychotic disorders (unless substance-induced or due to another medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or other severe psychiatric comorbidities confirmed by medical history and structured clinical assessment using the Mini-International Neuropsychiatric Interview (MINI version 7.0.2); 2. Current or history of alcohol or substance abuse within the past year; 3. A score of ≥3 on item 3 (suicide) of the HAMD-17, suicide attempt within the past year, or clinically assessed significant suicide risk; 4. Depression secondary to other severe medical conditions (e.g., hypothyroidism, Parkinson's disease, etc.); 5. Cardiovascular diseases: stroke or myocardial infarction within the past year, hypertension (blood pressure \>140/90 mmHg), or clinically significant arrhythmia; 6. Other significant comorbid diseases that may interfere with the interpretation of study results or pose risks to participant health (e.g., cardiovascular, respiratory, gastrointestinal, hepatic, renal, or other systemic diseases), as determined by the investigator; 7. Current participation in an interventional study for Major Depressive Disorder, or participation in such a study within 30 days prior to screening; 8. Having visited Wulongtan Park, Baotu Spring Park and Daming Lake Park for a prolonged period (single stay ≥1 hour) within the past three years.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong Not Yet Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong Recruiting

More Shandong Provincial Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180342 on ClinicalTrials.gov ↗ ← All trials in China