This trial examines if 8 weekly CBT + 4 bi-weekly active WBH sessions can help reduce MDD symptoms in adults 18+.
1 Primary · 4 Secondary · Reporting Duration: 2-3 weeks
Net Promoter Score
Sudden gains in antidepressant responses
Baseline and 12 weeks
Change in Beck Depression Inventory-II (BDI-II)
Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression
2 Treatment Groups
Active Whole-body Hyperthermia (Active Treatment)
1 of 2
Sham Whole-body Hyperthermia (Sham Treatment)
1 of 2
30 Total Participants · 2 Treatment Groups
Primary Treatment: Active Whole-body Hyperthermia (Active Treatment) · Has Placebo Group · N/A
Active Whole-body Hyperthermia (Active Treatment)Experimental Group · 2 Interventions: Active Whole-Body Hyperthermia (Active WBH), Cognitive Behavioral Therapy (CBT) · Intervention Types: Device, Behavioral
Sham Whole-body Hyperthermia (Sham Treatment)PlaceboComparator Group · 2 Interventions: Sham Whole-Body Hyperthermia (Sham WBH), Cognitive Behavioral Therapy (CBT) · Intervention Types: Device, Behavioral
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
Completed Phase 4
Screening: ~3 weeks
Reporting: 2-3 weeks
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
787 Previous Clinical Trials
657,429 Total Patients Enrolled
58 Trials studying Depression
32,939 Patients Enrolled for Depression
University of California, San FranciscoLead Sponsor
2,313 Previous Clinical Trials
11,758,338 Total Patients Enrolled
63 Trials studying Depression
19,877 Patients Enrolled for Depression
Ashley E Mason, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
186 Total Patients Enrolled
Frederick M Hecht, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
156 Total Patients Enrolled
Age 18+ · All Participants · 5 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
- Janssen CW, Lowry CA, Mehl MR, Allen JJ, Kelly KL, Gartner DE, Medrano A, Begay TK, Rentscher K, White JJ, Fridman A, Roberts LJ, Robbins ML, Hanusch KU, Cole SP, Raison CL. Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Aug 1;73(8):789-95. doi: 10.1001/jamapsychiatry.2016.1031. Erratum In: JAMA Psychiatry. 2016 Aug 1;73(8):878.
- Hanusch KU, Janssen CH, Billheimer D, Jenkins I, Spurgeon E, Lowry CA, Raison CL. Whole-body hyperthermia for the treatment of major depression: associations with thermoregulatory cooling. Am J Psychiatry. 2013 Jul;170(7):802-4. doi: 10.1176/appi.ajp.2013.12111395. No abstract available.
- 2023. "HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708976.
Frequently Asked Questions
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research program still being accepted?
"According to the details on clinicaltrials.gov, this particular trial has stopped recruiting participants since January 23rd 2023. Nevertheless, there are currently 1,379 other trials that have active recruitment open for enrollment." - Anonymous Online Contributor