HypErthermia as an Additional Treatment for the Biology and Experience of Depression (HEATBED)
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|ClinicalTrials.gov Identifier: NCT05041361|
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : May 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Cognitive Behavioral Therapy (CBT) Device: Whole-Body Hyperthermia (WBH)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HypErthermia as an Additional Treatment for the Biology and Experience of Depression: The HEAT BED Study|
|Actual Study Start Date :||October 11, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||January 30, 2023|
Experimental: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH)
Participants receive up to 4 bi-weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions. Each WBH session (including preparation and cool down) is up to approximately 3.5-4 hours, and each CBT session is approximately 50 minutes.
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 (WBH)
Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down will last 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH 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 101.3 F.
Other Name: Sauna Sessions
- Average Number of Planned WBH Sessions Completed [ Time Frame: 12 weeks ]Investigators will average and report the number of completed WBH sessions (4 WBH sessions planned per participant).
- Average Number of Planned Beck Depression Inventory-II (BDI-II) Assessments Completed [ Time Frame: 12 weeks ]Investigators will average and report the number of completed BDI-II assessments (10 planned per participant)
- Change in Beck Depression Inventory-II (BDI-II) from Baseline to 12-week Assessment [ Time Frame: Baseline and 12 weeks ]Change in BDI-II from baseline assessment to final assessment. BDI-II scores range from 0 to 63 with higher scores indicating more severe depression symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041361
|Contact: Anoushka Chowdhary, BAemail@example.com|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Anoushka Chowdhary, BA 415-514-8445 HEATBED@ucsf.edu|
|Principal Investigator: Ashley E Mason, PhD|
|Principal Investigator:||Ashley E Mason, PhD||University of California, San Francisco|
|Principal Investigator:||Frederick M Hecht, MD||University of California, San Francisco|