F32 F33
Conditions
Interventions
Group 1: Treatment group: Hyperthermic baths.
The hyperthermic baths were applied as head-out-of-water-immersion in a 40°C pool in a spa center near Freiburg, Germany, where 5 patients at a time could
Sponsors
Uni-Zentrum Naturheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: •Age 18 – 65 years •male or female •Depression (ICD F32/33) lasting longer than 4 weeks confirmed by a physician or psychotherapist •Hamilton Depression Scale Total Score =18 and a score =2 Item "depressive mood" at Screening and Baseline. •No change of antidepressant medication during the last 4 weeks and the trial foreseen
Exclusion criteria
Exclusion criteria: pregnancy, lactation, current and serious suicidal or homicidal risk (according to investigator’s judgment), serious concomitant disease (e.g. heart failure, renal failure, lung disease, open wounds), history of seizure disorder, organic mental disorders, alcohol or substance use within the last 6 months prior to the screen visit, schizophrenia, delusional disorder, psychotic disorders, bipolar disorder, antisocial personality disorder, heat urticaria, change of the antidepressive treatment within 4 weeks prior to the screen visit, treatment with beta-blocker or steroids and patients who don`t like hot baths.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression-17 (total score): Difference between baseline and T1 (after 4 interventions) in the intervention group compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Hamilton Rating Scale for Depression-17 (total score): Difference between groups 4 weeks after end of treatment (follow up). • Hamilton Rating Scale for Depression-17 sub scales: Difference between groups after 4 treatments and 4 weeks after end of treatment (follow up). • Heart Rate Variability (parameter): Total Heart Rate Variability, Low Frequency, High Frequency) and heart rate during sleep (21:00 - 04:00 h) after 4 treatments and 4 weeks after end of treatment (follow up) compared to the control group and correlation with Hamilton Rating Scale for Depression-17 (total score) and subscales. • Adverse effects. • Global judgement of efficacy and tolerability on a 5-item scale by the participants. • Core body temperature measured by an ear thermometer before and after the bath and after the resting time. | — |
Countries
Germany
Contacts
Public ContactSonja Kaifel
Uni-Zentrum für Naturheilkunde / Department of Environmental Health Sciences Universitätsklinikum Freiburg
Outcome results
None listed