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NCT05708976: HEATBED2

HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2

Completed NA Results posted Last updated 30 October 2025
What this trial tests

NA trial testing Cognitive Behavioral Therapy (CBT) in Major Depressive Disorder in 30 participants. Completed in 30 September 2024.

Timeline
15 February 2023
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date15 February 2023
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Major Depressive Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Net Promoter Score, and Enrollment Likelihood Primary · 12 weeks

Study acceptability was indexed by participant-reported net-promoter scores. This is a response to a single question: "How likely would you be to recommend \[participation in a study or treatment like this\] to a friend or family member with depression?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend). Study acceptability was also indexed by an additional patient-reported metric, Enrollment Likelihood. Enrollment likelihood was a response to the question: "How likely would you be to enroll in this study given your experience in this study?" and respons

Net Promoter Score (0-10)
GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)7.73± 2.15
Sham Whole-body Hyperthermia (Sham Treatment)8.00± 2.08
Enrollment Likelihood (1-5)
GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)4.13± 1.06
Sham Whole-body Hyperthermia (Sham Treatment)4.29± 0.83
Change in Beck Depression Inventory-II (BDI-II) Secondary · Baseline and 12 weeks

Change in BDI-II from baseline assessment to final assessment. Scores range from 0 to 63 and items are summed to create a total score; higher scores indicate greater depression symptoms.

GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)-19.07± 2.69
Sham Whole-body Hyperthermia (Sham Treatment)-21.10± 2.41
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression Secondary · Baseline and 12 weeks

Change in PROMIS8a Depression from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms. A T-score of 60 indicates sub-clinical or elevated levels of depression. A T score of 50 indicates the population mean with a standard deviation of 10.

GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)-10.79± 2.66
Sham Whole-body Hyperthermia (Sham Treatment)-11.54± 2.84
Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report Secondary · Baseline and 12 weeks

Change in HAMD-6 from baseline to final assessment. Scores range from 0 to 22, and items are summed to create a total score; higher scores indicate greater depression symptoms.

GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)-6.42± 1.30
Sham Whole-body Hyperthermia (Sham Treatment)-7.16± 1.12
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety Secondary · Baseline and 12 weeks

Change in PROMIS4a Anxiety from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms. A T-score of 60 indicates sub-clinical or elevated levels of anxiety. A T score of 50 indicates the population mean with a standard deviation of 10.

GroupValue95% CI
Active Whole-body Hyperthermia (Active Treatment)-7.24± 1.63
Sham Whole-body Hyperthermia (Sham Treatment)-7.51± 2.06

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Whole-body Hyperthermia (Active Treatment)
Serious: 0/15 (0%)
Deaths: 0/15
Sham Whole-body Hyperthermia (Sham Treatment)
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (14 terms — click to expand)

ReactionSystemActive Whole-body Hyperthe…Sham Whole-body Hypertherm…
HeadacheNervous system disorders
LightheadednessGeneral disorders
NauseaGastrointestinal disorders
MigraineNervous system disorders
FatigueGeneral disorders
VomitingGastrointestinal disorders
BruisingBlood and lymphatic system disorders
Sleep DisturbanceGeneral disorders
Head PressureGeneral disorders
ChillsGeneral disorders
Stomach painGastrointestinal disorders
Dry mouthGeneral disorders
FluInfections and infestations
Knee surgerySurgical and medical procedures

Data from ClinicalTrials.gov NCT05708976 adverse events section.

Sponsor's own description

This randomized two-arm intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly active whole-body hyperthermia (active WBH) sessions or 4 bi-weekly sham WBH sessions to adults aged 18 years or older with major depressive disorder (MDD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT).
    Mason AE, Chowdhary A, Hartogensis W, Siwik CJ, et al · · 2024 · cited 7× · PMID 38743265 · DOI 10.1080/02656736.2024.2351459
  2. A Randomized Trial Testing a Novel Mind and Body Intervention for Depression: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH).
    Mason AE, Hartogensis W, Chowdhary A, Siwik CJ, et al · · 2025 · PMID 41146956 · DOI 10.1177/27536130251387714

Verify or expand the search:

Other trials of Cognitive Behavioral Therapy (CBT)

Trials testing the same drug.

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05708976.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing