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COMPLETED
NCT05708976
NA

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-02-15

Completion Date

2024-09-30

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician will administer 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.

DEVICE

Active Whole-Body Hyperthermia (Active WBH)

Active whole-body hyperthermia (active WBH) will be administered by trained research assistants. Preparation for the active WBH session, the active WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the active heating phase will last until the participants has achieved a core (rectal) temperature of 38.5 C.

DEVICE

Sham Whole-Body Hyperthermia (Sham WBH)

Sham whole-body hyperthermia (sham WBH) will be administered by trained research assistants. Preparation for the sham WBH session, the sham WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the sham WBH session will minimally impact core body temperature.

Locations (1)

University of California San Francisco

San Francisco, California, United States