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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05708976
Status
Completed

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.
  • Active Whole-Body Hyperthermia (Active WBH) — 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.
  • Sham Whole-Body Hyperthermia (Sham WBH) — DEVICE
    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.

Study Details

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 Dates

Start date
Feb 15, 2023
Status verified
May 2026
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Whole-body Hyperthermia (Active Treatment)
    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.
  • Placebo Comparator: Sham Whole-body Hyperthermia (Sham Treatment)
    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.

Primary Outcome Measure

Net Promoter Score, and Enrollment Likelihood [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California San Francisco· San Francisco, CA

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