Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT)

Abstract

Background: There is a pressing need for effective treatments for major depressive disorder (MDD).

Objective

To examine the feasibility of an integrated mind-body MDD treatment combining cognitive behavioral therapy (CBT) and whole-body hyperthermia (WBH).

Methods

In this single-arm trial, 16 adults with MDD initially received 8 weekly CBT sessions and 8 weekly WBH sessions. Outcomes included WBH sessions completed (primary), self-report depression assessments completed (secondary), and pre-post intervention changes in depression symptoms (secondary). We also explored changes in mood and cognitive processes and assessed changes in mood as predictors of overall treatment response.

Results

Thirteen participants (81.3%) completed ≥ 4 WBH sessions (primary outcome); midway through the trial, we reduced from 8 weekly to 4 bi-weekly WBH sessions to increase feasibility. The n = 12 participants who attended the final assessment visit completed 100% of administered self-report depression assessments; all enrolled participants (n = 16) completed 89% of these assessments. Among the n = 12 who attended the final assessment visit, the average pre-post-intervention BDI-II reduction was 15.8 points (95% CI: −22.0, −9.70), p = 0.0001, with 11 no longer meeting MDD criteria (secondary outcomes). Pre-post intervention improvements in negative automatic thinking, but not cognitive flexibility, achieved statistical significance. Improved mood from pre-post the initial WBH session predicted pre-post treatment BDI-II change (36.2%; rho = 0.60, p = 0.038); mood changes pre-post the first CBT session did not.

Limitations

Small sample size and single-arm design limit generalizability.

Conclusion

An integrated mind-body intervention comprising weekly CBT sessions and bi-weekly WBH sessions was feasible. Results warrant future larger controlled clinical trials.

Clinivaltrials.gov Registration: NCT05708976

Keywords:

• Whole-body hyperthermia
• body temperature
• feasibility
• acceptability
• depression

Acknowledgments

The authors thank Sean B. Fender for his assistance in developing the WBH protocol.

Disclosure statement

CLR serves as a consultant for Usona Institute, Novartis, Emory Healthcare and Biogen/Sage. CAL is Cofounder, Board Member, and Chief Scientific Officer of Mycobacteria Therapeutics Corporation, and is a member of the faculty of the Integrative Psychiatry Institute, Boulder, Colorado, the Institute for Brain Potential, Los Banos, California, USA, and Intelligent Health Ltd, Reading, UK. AEM has received financial renumeration from Oura Ring, Inc. for consulting. RPP is cofounder of FoundMyFitness, LLC, and frequently lectures on the science of sauna as a potentially healthful modality through podcasts, videos, and articles published on foundmyfitness.com. JCN serves as a consultant to Biohaven, Johnson and Johnson, Novartis, and Otsuka, and receives royalties from UpToDate.

Data availability statement

The data that support the findings will be available at OSF (https://osf.io/), together with a data dictionary, upon publication.

Additional information

Funding

This work was funded by the National Institutes of Health (NIH), National Center for Complimentary and Integrative Health (NCCIH; R34AT011221), the Aoki Foundation, the Donner Foundation, and the Tiny Foundation.