F32 F33
Conditions
Interventions
Group 1: Hyperthermic baths (HTB) with 2 applications per week + treatment as usual (TAU)
Group 2: Thermoneutral baths (TNB) with 2 applications per week + treatment as usual (TAU)
Group 3: Treatment
drug therapy and/or psychotherapy)
Sponsors
Uniklinik Freiburg, Uni-Zenrum Naturheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form (ICF) • Outpatients (both male and female) between the age of 18-70 who are receiving treatment as usual or who are off antidepressant therapy for at least 4 weeks prior to baseline • confirmed diagnosis of depression (ICD-10 F32/F33 criteria for single or recurrent nonpsychotic depression >2 weeks) • MADRS score indicating at least a moderate depression (MADRS = 20)
Exclusion criteria
Exclusion criteria: - Acute risk of suicide - Change of antidepressant therapy within <4 weeks prior to baseline or intention to change antidepressant therapy within the next two weeks - Other mental disorder (i.e. borderline personality disorder, bipolar affective disorder, drug and/or alcohol abuse, schizophrenia, anxiety disorder, psychotic depression) - Contraindication for hot baths (i.e. open wounds, heat urticaria, varicosis, multiple sclerosis, epilepsy, orthostatic dysregulation, pregnancy) - Severe organic disease (i.e. heart failure) - Ongoing pension claim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity - observer rating: MADRS score after 2 weeks (observer rating) | — |
Secondary
| Measure | Time frame |
|---|---|
| After 4 and 8 weeks and at 4-month follow-up (observer and self-rating): - Depression: MADRS score - Depression: PHQ-9 questionnaire - Sleep quality: PSQI questionnaire - Health-related quality of life: EuroQoL EQ-5D-5L questionnaire - Client satisfaction: CSQ-8 questionnaire | — |
Countries
Germany
Contacts
Public ContactRoman Huber
Uniklinik Freiburg, Uni-Zenrum Naturheilkunde
Outcome results
None listed