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Table 1 Diagram of the study protocol

From: Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial

    2 weeks 2 weeks 4 weeks
  Screening Baseline/Randomization After 4 interventions   Follow-up
   T0 T1   T2
HTB target (n)a    4 4  
17-item HAM-D x x x   x
Medical historyb   x    
HRVc   x x   x
Global judgement of efficacy    x   x
Global judgement of tolerability    x   x
Adverse eventsd    x x x
  1. Assessments of psychometry and heart rate variability parameters (HRV) were conducted at baseline (T0), after 2 weeks of treatment (T1), and 4 weeks after discontinuation of treatment (T2). Note that assessments were not conducted after 4 weeks of treatment
  2. a HTB: hyperthermic baths; temperature of bath; ear-temperature before/after bath; ear-temperature after rest; duration of bath (target 30 min); duration of rest
  3. bDuration of depression; approved diagnosis family/consulting physician; intake of psychometric drugs no/yes; psychotherapy no/yes; psychiatric hospital stays
  4. c Application of portable ECG for overnight measurement
  5. d Adverse events were documented before and after each treatment