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

NCT ID: NCT07180342

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-09
• Study Completion Date: 2027-09-18

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.

Detailed Description

This study is an interventional randomized controlled trial aimed at evaluating whether natural tourism activities can improve the clinical symptoms of patients with Major Depressive Disorder and exploring the multidimensional mechanisms involving physiological, psychological, and social functioning. The target participant population is adult patients aged 18-60 who meet the DSM-5 diagnostic criteria for a major depressive episode. The core question to be addressed is whether the natural tourism intervention can significantly reduce the MADRS scores of patients with Major Depressive Disorder.

Researchers will compare the intervention group (receiving structured tourism activities + conventional drug therapy) with the control group (receiving conventional drug therapy only) to verify the improvement effect of the tourism intervention on depressive symptoms and its potential mechanisms.

Participants will complete the following tasks:

• Participate in a one-day structured natural tourism activity;
• Complete multiple scale assessments (including MADRS, HAMD-17, GAD-7, etc.) at baseline, on the day of intervention, and at one week and two weeks after the intervention;
• Wear smart wearable devices to monitor physiological indicators such as sleep, heart rate and stress levels.

From a theoretical perspective, this study promotes the transformation of tourism research from a "pleasure consumption" paradigm to a "neurobiological intervention" paradigm, aiming to propose an interdisciplinary mechanistic research pathway that reveals the positive therapeutic effects of tourism experiences on the pathology of Major Depressive Disorder. From a policy perspective, validating the clinical utility of tourism may reshape social prescription systems. While countries such as New Zealand and the United Kingdom have piloted "nature prescription" programs, there remains a lack of disease-specific protocols and efficacy evidence. Therefore, structured tourism interventions are expected to become a cost-effective complement to traditional treatments.

As an interdisciplinary product integrating tourism and medicine, tourism therapy may emerge as a promising non-pharmacological prevention and treatment strategy. For tourism academia, it facilitates a theoretical transition from enhancing general well-being to clinical therapeutic applications; for mental health practice, it has the potential to break away from conventional treatments and establish itself as a novel therapeutic modality. Thus, in-depth exploration of the mechanisms through which tourism benefits patients with Major Depressive Disorder holds significant theoretical and practical implications.

Employing a randomized controlled trial design, this study transcends the inherent limitations of cross-sectional research, aiming to provide innovative solutions to the global mental health crisis. The findings are expected to not only enrich guidelines for non-pharmacological interventions but also advance the transformation of the tourism industry toward a healing economy paradigm.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Tourism-based intervention

Intervention Type: 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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Guoqing Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status: NOT_YET_RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuping Shen

Role: CONTACT

202413185@mail.sdu.edu.cn

+86 15545188353

Facility Contacts

Shuping Shen

Role: primary

202413185@mail.sdu.edu.cn

+86 15545188353

Shuping Shen

Role: primary

202413185@mail.sdu.edu.cn

+86 15545188353

Other Identifiers

2025-1057

Identifier Type: -

Identifier Source: org_study_id