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| Name | Class |
|---|---|
| Shandong University | OTHER |
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Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms | MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse) | Baseline, intervention day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Response from Depression | MADRS (Clinician-focused), ≥50% reduction from baseline in MADRS total score | Baseline, 2-week follow-up |
| Remission from Depression | MADRS (Clinician-focused), MADRS total score ≤10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Change from baseline in Q-LES-Q-SF total score(higher = better) | Baseline, 2-week follow-up |
| Change in quality of life | Change from baseline in EQ-5D-5L total score ( higher = worse) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuping Shen | Contact | +86 15545188353 | 202413185@mail.sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Not yet recruiting | Jinan | Shandong | China |
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| Baseline, 2-week follow-up |
| Change in Depressive Symptoms | Change from baseline in HAM-D-17 (Clinician-focused), total score(higher = worse) | 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) | 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) | 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) | 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"). | Baseline, 2-week follow-up |
| Baseline, 2-week follow-up |
| Change in quality of life | Change from baseline in ISI total score(higher = worse) | Baseline, 2-week follow-up |
| Change in functional impairment | Change from baseline in WSAS total score (higher = worse) | Baseline, 2-week follow-up |
| Change in functional impairment | Change from baseline in SDS total score(higher = worse) | Baseline, 2-week follow-up |
| Change in cognitive function | Change from baseline in PDQ-D-20 total score (higher = worse) | Baseline, 2-week follow-up |
| Physiological Variability | stress score change from baseline (higher = worse). Monitoring the stress levels of enrolled participants using smart wearable devices. The Heart Rate Variability (HRV) data collected by smart wearable devices is input into a specialized stress calculation model. This model comprehensively considers parameters such as the time-series features and frequency-domain features of the Heart Rate Variability. Utilizing machine learning or statistical analysis methods, the model establishes a mapping relationship between HRV and stress state to estimate the user's current stress level, which is then presented in the form of a stress score. | Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up |
| Physiological Variability | Heart rate change from baseline | Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up |
| Physiological Variability | Sleep metrics change from baseline. Monitoring the total sleep duration of enrolled participants using smart wearable devices. | Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up |
| Physiological Variability | Sleep metrics change from baseline. Monitoring the duration of deep sleep for enrolled participants using smart wearable devices. | Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up |
| Physiological Variability | Sleep metrics change from baseline. Monitoring the number of awakenings for enrolled participants using smart wearable devices. | Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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