Trial results for a study evaluating whole-body hyperthermia as an additional treatment for Depression were posted on ClinicalTrials.gov on 2025-10-30, showing a mean change in Beck Depression Inventory-II (BDI-II) of -19.07 for active treatment and -21.10 for sham treatment.

Background

Major Depressive Disorder (MDD) is a common and serious mood disorder characterized by persistent sadness and loss of interest. Cognitive behavioral therapy (CBT) is a recognized treatment for depression. This trial explored whole-body hyperthermia as an adjunctive therapy to CBT, aiming to investigate its potential impact on the biology and experience of depression.

Trial design

This randomized two-arm intervention trial, designated as Phase NA, enrolled 30 adults aged 18 years or older with Major Depressive Disorder or Depression. Participants received 8 weekly cognitive behavioral therapy (CBT) sessions. One arm received 4 bi-weekly active whole-body hyperthermia (active WBH) sessions, while the comparator arm received 4 bi-weekly sham WBH sessions. The trial aimed to evaluate the effects of hyperthermia as an additional treatment.

Key results

The trial results provided several key measurements across both treatment arms:

What this means

The posted results indicate that both active whole-body hyperthermia combined with cognitive behavioral therapy (CBT) and sham hyperthermia combined with CBT led to reductions in depression and anxiety symptoms in adults with major depressive disorder. Specifically, the mean change in Beck Depression Inventory-II (BDI-II) was -19.07 for the active group and -21.10 for the sham group, suggesting comparable, if not slightly greater, symptom improvement in the sham arm. Similar trends were observed across other scales, including Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression, Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report, and PROMIS 4a Anxiety, where the sham group consistently showed slightly larger mean reductions in scores. The Net Promoter Scores for enrollment likelihood were also slightly higher in the sham group. These findings suggest that the addition of active whole-body hyperthermia did not demonstrate a clear advantage over sham treatment in this study for improving depression and anxiety symptoms.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05708976, titled "HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2", were posted on 2025-10-30 on clinicaltrials.gov.