Assessing Multi-site Feasibility of an Integrated Whole-body Hyperthermia and Behavioral Intervention for Major Depressive Disorder: The MULTIBED Study
University of California, San Francisco
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).
Description
Major Depressive Disorder afflicts more than hundreds of millions of people worldwide and is the leading cause of life years lost to disability. Current treatments have important limitations in efficacy and, in the case of medication, substantial side effects. There is thus a compelling need for additional effective, well-tolerated treatments. One such potential treatment is whole-body hyperthermia (WBH). The investigators hypothesize that WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This randomized 2x2 facto…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years or older * Able to read and speak in English * Able to understand the nature of the study and able to provide written informed consent * Current major depressive episode of at least 2 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Patient Health Questionnaire - 8 (PHQ-8) score of 10 or greater at screening * Willing to use a form of pregnancy contraceptive (e.g., barrier methods such as condoms, oral contraception, or other birth control type) if assigned female sex at birth and premenopausal * Able to lie supine for 2 hou…
Interventions
- BehavioralCognitive 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.
- DeviceWhole-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 HealthSan Francisco, California
- Massachusetts General Hospital (MGH)Boston, Massachusetts
- Cleveland Clinic FoundationCleveland, Ohio