CBT + Hyperthermia for Depression
(HEATBED2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byFrederick M Hecht, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses talk therapy and body heating sessions to help adults with major depression. It aims to find better treatment options by combining these methods. Talk therapy changes negative thoughts and behaviors, while body heating might boost mood.

Research Team

Ashley E Mason, PhD

Principal Investigator

University of California, San Francisco

Frederick M Hecht, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 18 with major depression for at least 2 weeks, scoring >21 on the Beck Depression Inventory-II. Participants must understand the study, consent in writing, have a smartphone for app use, and lie on their back for sauna sessions. Excluded if they can't fit in the sauna device, are pregnant or breastfeeding, attempted suicide recently or have certain suicidal thoughts, take medications affecting body temperature regulation or antidepressants (unless off them for 4 weeks), engage in heavy exercise before sessions or use nicotine regularly.

Inclusion Criteria

Must have smartphone onto which the participant can download an app from Apple App or Google Play stores

Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures

I am 18 years old or older.

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Exclusion Criteria

I cannot fit into the sauna device.

Known hypersensitivity to hyperthermia and/or infrared exposure

I do not regularly use nicotine products or can avoid them for 48 hours around my treatment.

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Treatment Details

Interventions

Active Whole-Body Hyperthermia (Active WBH) (Procedure)
Cognitive Behavioral Therapy (CBT) (Behavioral Intervention)
Sham Whole-Body Hyperthermia (Sham WBH) (Procedure)

Trial OverviewThe trial tests whether adding whole-body hyperthermia to cognitive behavioral therapy helps adults with major depressive disorder. It compares active hyperthermia treatments to sham (fake) ones alongside weekly CBT sessions. Participants are randomly assigned to receive either real or sham heat treatments bi-weekly.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Whole-body Hyperthermia (Active Treatment)Experimental Treatment2 Interventions

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each active WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Group II: Sham Whole-body Hyperthermia (Sham Treatment)Placebo Group2 Interventions

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly sham whole-body hyperthermia (WBH) sessions, which minimally raise body temperature. Each sham WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Cognitive Behavioral Therapy (CBT) is already approved in Canada for the following indications: