Major Depressive DisorderMDDNCT07180342
An Empirical Study on the Mechanisms of Biopsychosocial Functional Improvement in Patients With Major Depressive Disorder Through Nature-Based Tourism Activities
A study testing Tourism-based intervention in people with Major Depressive Disorder, run by Shandong Provincial Hospital at 2 sites in China.
Trial summary
Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Tourism-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesChina
- Study dates
- 9 Oct 2025to 18 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Shuping Shen, +86 15545188353, 202413185@mail.sdu.edu.cn
Guoqing Zhao
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Shuping Shen, +86 15545188353, 202413185@mail.sdu.edu.cn
Guoqing Zhao
About this study
Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.
Read the 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
- Being tested
- Tourism-based intervention
- Keywords
- Major Depressive Disorder, Tourism, MMD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourism-based interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms
MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)
Measured: Baseline, intervention day 1
Secondary outcomes (7)
Response from Depression
MADRS (Clinician-focused), ≥50% reduction from baseline in MADRS total score
Measured: Baseline, 2-week follow-up
Remission from Depression
MADRS (Clinician-focused), MADRS total score ≤10
Measured: Baseline, 2-week follow-up
Change in Depressive Symptoms
Change from baseline in HAM-D-17 (Clinician-focused), total score(higher = worse)
Measured: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Depressive Symptoms
Change from baseline in PHQ-9 (Patient-centered), total score(higher = worse)
Measured: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Depressive Symptoms
Change from baseline in QID-SR-16 (Patient-centered), total score(higher = worse)
Measured: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Anxiety Symptoms
GAD-7 (Patient-centered), Change from baseline in GAD-7 total score(higher = worse)
Measured: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Clinical Improvement
CGI-I response (defined as a CGI-I score of "very much improved" or "much improved").
Measured: Baseline, 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start9 Oct 2025
- Primary completion18 Mar 2027 (estimated)
- Study completion18 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Guoqing Zhao, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180342
- Sponsor's protocol ID
- 2025-1057
- Acronym
- MDD
- Status last verified
- Dec 2025
- First submitted
- 6 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Empirical Study on the Mechanisms of Biopsychosocial Functional Improvement in Patients With Major Depressive Disorder Through Nature-Based Tourism Activities
- ClinicalTrials.gov ID
- NCT07180342
- Acronym / sponsor ID
- MDD / 2025-1057
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Tourism, MMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Shandong University
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 18 Sep 2027 (estimated)
- First posted
- 18 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Tourism-based interventionFollowing 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 | 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Tourism-based interventionFollowing 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. | Behavioural | Intervention Group |
Primary outcome
Change in Depressive Symptoms
Time frame: Baseline, intervention day 1
MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)
7 secondary outcomes
Response from Depression
Time frame: Baseline, 2-week follow-up
Remission from Depression
Time frame: Baseline, 2-week follow-up
Change in Depressive Symptoms
Time frame: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Depressive Symptoms
Time frame: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Depressive Symptoms
Time frame: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Change in Anxiety Symptoms
Time frame: Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up
Clinical Improvement
Time frame: Baseline, 2-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourism-based intervention in people with Major Depressive Disorder, run by Shandong Provincial Hospital at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuping Shen (+86 15545188353, 202413185@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: Baseline, intervention day 1). 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 16 Dec 2025.