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Whole-body hyperthermia for major depressive disorder: randomized sham-controlled trial

Six-week double-blind RCT (NCT01625546): medication-free adults with MDD received one session of active whole-body hyperthermia versus a sham procedure matched for time and nonspecific factors; active treatment produced larger reductions in 17-item Hamilton Depression Rating Scale scores than sham through week 6, with strongest between-group separation in the first two weeks.

Design

  • Population: medically healthy adults 18–65 y with MDD, no psychotropic drugs, baseline HDRS-17 ≥ 16
  • Randomization: 34 participants; 30 received an intervention; 29 had ≥1 post-intervention assessment (modified ITT)
  • Intervention: single session active WBH vs sham matched for duration and nonspecific aspects except intense heat
  • Blinding: staff performing outcomes blinded; immediately post-session, 71.4% of sham and 93.8% of active participants believed they had received WBH (expectancy nuance)

Primary outcome pattern (HDRS-17; WBH minus sham, abstract)

  • Week 1: −6.53 (95% CI −9.90 to −3.16; P < .001)
  • Week 2: −6.35 (95% CI −9.95 to −2.74; P = .001)
  • Week 4: −4.50 (95% CI −8.17 to −0.84; P = .02)
  • Week 6: −4.27 (95% CI −7.94 to −0.61; P = .02)

Authors report significance after considering baseline expectancy differences.

Evidence hygiene

  • Small pilot n — hypothesis-generating for device-delivered hyperthermia, not interchangeable with habitual dry-sauna epidemiology or hot-bath insulin-sensitivity RCTs on this wiki.
  • Erratum: PubMed lists correction discussion PMID 27409072 — read alongside primary tables.

Distinct protocols

  • Chronic heat adaptation / Heat therapy / Sauna — different stimulus, dose, and outcome literatures; use this row when the question is induced-core-temperature WBH for mood specifically.

Outcomes

  • Depression & Anxiety Composite Score
    HDRS-17 between-group difference (active WBH vs sham) at week 1: −6.53 points (95% CI −9.90 to −3.16; P < .001).
  • Depression & Anxiety Composite Score
    HDRS-17 between-group difference at week 6: −4.27 points (95% CI −7.94 to −0.61; P = .02), persisting after expectancy covariates per abstract.
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