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NOT YET RECRUITING
NCT07596914
NA

Multi-site Feasibility of an Integrated Treatment for the Biology and Experience of Depression: The MULTIBED Study

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

This randomized 2x2 factorial intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions (yes/no) and 4 bi-weekly active whole-body hyperthermia (WBH) sessions (yes/no) to adults aged 18 years or older with major depressive disorder (MDD).

Official title: Assessing Multi-site Feasibility of an Integrated Whole-body Hyperthermia and Behavioral Intervention for Major Depressive Disorder: The MULTIBED Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08-01

Completion Date

2029-03-31

Last Updated

2026-05-19

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

Whole-Body Hyperthermia

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.

Locations (3)

University of California, San Francisco, Osher Center for Integrative Health

San Francisco, California, United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States