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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07596914
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy (CBT) — BEHAVIORAL
    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.
  • Whole-Body Hyperthermia — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: No Interventions
    No study-provided interventions. In this design, participants randomized to receive neither intervention can receive any treatment recommended by their healthcare provider (except for engagement with new WBH practices).
  • Experimental: WBH Only
    Participants receive 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each WBH session (including preparation and post-session activities) is up to approximately 3.5 hours.
  • Experimental: CBT Only
    Participants receive 8 cognitive behavioral therapy (CBT) sessions. Each CBT session is approximately 50 minutes.
  • Experimental: WBH and CBT
    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 WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Primary Outcome Measure

Retention [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, San Francisco, Osher Center for Integrative HealthSan FranciscoCalifornia94115
Sarah M Fisher, MA
[email protected]
415-514-8445
Ashley E Mason, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital (MGH)BostonMassachusetts02114
Maren Nyer, PhD
[email protected]
Maren Nyer, PhD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Narissa McCarty
[email protected]
216-780-1931
Chelsea Siwik, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, San Francisco, Osher Center for Integrative Health· San Francisco, CAMassachusetts General Hospital (MGH)· Boston, MACleveland Clinic Foundation· Cleveland, OH

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