An Empirical Study on the Mechanisms of Biopsychosocial Functional Improvement in Patients With Major Depressive Disorder Through Nature-Based Tourism Activities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in Depressive Symptoms
研究概览
简要总结
Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Depressive Symptoms
时间窗: Baseline, intervention day 1
MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)
Change in Depressive Symptoms
时间窗: Baseline, intervention day 1
MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)
次要结局
- Response 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 Anxiety Symptoms(Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up)
- Clinical Improvement(Baseline, 2-week follow-up)
- 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 Anxiety Symptoms(Baseline, intervention day 1, 1-week follow-up, and 2-week follow-up)
- Clinical Improvement(Baseline, 2-week follow-up)
研究者
Guoqing Zhao
Principal Investigator
Shandong Provincial Hospital