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

NCT07180342 | Recruiting DMC

• 1 other identifier: 2025-1057
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Tourism; MMD

Outcome Measures

Primary Outcomes (1)

• Change in Depressive Symptoms

  MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)

  Baseline, intervention day 1

Secondary Outcomes (7)

• Response from Depression

  Baseline, 2-week follow-up

• Remission from Depression

  Baseline, 2-week follow-up

• Change in Depressive Symptoms

  Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up

• Change in Depressive Symptoms

  Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up

• Change in Depressive Symptoms

  Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up

Other Outcomes (11)

• Change in quality of life

  Baseline, 2-week follow-up

• Change in quality of life

  Baseline, 2-week follow-up

• Change in quality of life

  Baseline, 2-week follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Tourism-based intervention

Control Group

NO 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.

Interventions

Tourism-based intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participate in the study and sign the informed consent form;
• Age between 18 (inclusive) and 60 (exclusive) at the screening period;
• 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);
• Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17 at both screening and baseline;
• Physically stable based on medical history and vital signs (including blood pressure);
• 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.

You may not qualify if:

• 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);
• Current or history of alcohol or substance abuse within the past year;
• A score of ≥3 on item 3 (suicide) of the HAMD-17, suicide attempt within the past year, or clinically assessed significant suicide risk;
• Depression secondary to other severe medical conditions (e.g., hypothyroidism, Parkinson's disease, etc.);
• Cardiovascular diseases: stroke or myocardial infarction within the past year, hypertension (blood pressure \>140/90 mmHg), or clinically significant arrhythmia;
• 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;
• Current participation in an interventional study for Major Depressive Disorder, or participation in such a study within 30 days prior to screening;
• Having visited Wulongtan Park, Baotu Spring Park and Daming Lake Park for a prolonged period (single stay ≥1 hour) within the past three years.

Sponsors & Collaborators

• Shandong University: collaborator
• Shandong Provincial Hospital: lead

Study Sites (2)

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

NOT YET RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Shuping Shen

CONTACT

+86 15545188353; 202413185@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 18, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): September 18, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)