Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.
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;
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.);
Parallel
Tourism-based intervention
BehavioralFollowing 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.
Change in Depressive Symptoms
MADRS (Clinician-focused), Change from baseline in MADRS total score (range 0-60; higher = worse)
Response from Depression
MADRS (Clinician-focused), ≥50% reduction from baseline in MADRS total score
Remission from Depression
MADRS (Clinician-focused), MADRS total score ≤10
Change in Depressive Symptoms
Change from baseline in HAM-D-17 (Clinician-focused), total score(higher = worse)
Change in Depressive Symptoms
Change from baseline in PHQ-9 (Patient-centered), total score(higher = worse)
Change in quality of life
Change from baseline in Q-LES-Q-SF total score(higher = better)
Change in quality of life
Change from baseline in EQ-5D-5L total score ( higher = worse)
Change in quality of life
Change from baseline in ISI total score(higher = worse)
Change in functional impairment
Change from baseline in WSAS total score (higher = worse)
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Shandong Provincial Hospital
Lead sponsor
Shandong University
Collaborator
