Hyperthermic baths in patients with depression – effects on symptoms and heart rate variability. A randomized controlled pilot study

Not Applicable

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00004803
• Lead Sponsor: ni-Zentrum Naturheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-12-12
• Study Start: 2016-02-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Hamilton Rating Scale for Depression-17 (total score): Difference between groups 4 weeks after end of treatment (follow up).<br><br>• Hamilton Rating Scale for Depression-17 sub scales: Difference between groups after 4 treatments and 4 weeks after end of treatment (follow up).<br><br>• 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.<br><br>• Adverse effects.<br>• Global judgement of efficacy and tolerability on a 5-item scale by the participants.<br>•Core body temperature measured by an ear thermometer before and after the bath and after the resting time.<br><br>