light to moderate depressions
Conditions
Interventions
Group 1: Arm 1: In addition to their standard routine care, patients in the nature therapy (NT) arm receive a total of 8 weekly sessions led by trained nature therapists in small groups (up to 10 pati
continuation of existing antidepressant medication in accordance with guidelines, including phytotherapeutic treatment, e.g., St. John’s wort). Stays in nature are document
Sponsors
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: A specialist diagnosis of mild to moderate depression according to the DSM-5 criteria The patient’s willingness to be randomized and to participate in the interventions and examinations as part of the study, as well as to complete questionnaires and diaries Proficiency in the German language Intact hearing and speech comprehension Sufficient mobility to participate in nature therapy The patient is capable of giving informed consent and is cognitively and linguistically able to assess the significance of the study Signed informed consent form
Exclusion criteria
Exclusion criteria: 1) Severe mental health conditions: major depressive disorder, past or current psychosis, acute self-harm or suicidal tendencies, post-traumatic stress disorder, personality disorder, substance use disorder, severe anxiety disorder 2) Moderate or severe acute or chronic physical illness, such as cancer or severe autoimmune diseases, that could affect study participation. 3) Current treatment or treatment within the last 3 months with naturopathy and/or hypnosis 4) Planned initiation of antidepressant medication within the next 16 weeks or recent initiation of antidepressant medication within the last 3 months 5) Planned start of psychotherapy within the next 16 weeks or start of psychotherapy within 3 months prior to study enrollment 6) Planned participation in an intervention study during the same period as the study or within the last 3 months prior to the start of the study 7) Affiliation with the study center (e.g., employee) 8) Current application for disability benefits 9) Application for rehabilitation under review 10) Not used regularly (at least 3 times a week) and should not be newly introduced: mind-body medicine, autogenic training, hypnosis, natural therapies 11) Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of depression as assessed by a blinded evaluator using the MADRS (Montgomery-Åsberg Depression Rating Scale) after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Blinded external assessment of the severity of depression using the MADRS at Week 16 - Depression assessed using the Beck Depression Inventory-II (BDI-II) at Weeks 8 and 16 - Subjective stress perception using the Perceived Stress Scale-10 (PSS), measurement points: Week 8, Week 16 - Mental well-being using the World Health Organization-Five Well-Being Index (WHO-5) in the diary weekly during Weeks 1–8 at the end of each week and in the questionnaire after Week 16 - Connection to nature using the Connectedness to Nature Scale (CNS) at Week 8 and Week 16 - Mindfulness using the Mindful Attention and Awareness Scale (MAAS) at Week 8 and Week 16 - Patients’ overall assessment of changes (PGI-C), assessment points: Week 8 and Week 16 - Treatment safety: The number and type of treatment-related adverse events (UTW), adverse events (UE), and serious adverse events (SUE) are recorded and analyzed in the study diary throughout the entire study period between baseline and Week 8 and Weeks 9–16. Similarly, changes in medication or initiation of medication for the treatment of depression are documented weekly between baseline and week 16. - Adherence to the study intervention: Frequency and duration of interventions measured by participation in the weekly sessions up to week 8, as well as the number of weeks with at least 3 independent exercises up to week 8 and in weeks 9–16; total number and duration of independent exercises per week up to week 8 and in week and in week 9-16 Health economic issues: - Health resources actually utilized (direct resource use, including medical consultations, hospital stays, drug therapies, and rehabilitation measures) - Absences from work due to illness (indirect factors, particularly lost workdays) Additional assessments: - Suggestibility in the HT study arm, measured using the Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A), is assessed at baseline and in the HT group after week 8. - Concomitant medicat | — |
Countries
Germany
Contacts
Public ContactBenno Brinkhaus
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Outcome results
None listed