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HypErthermia as an Additional Treatment for the Biology and Experience of Depression (HEATBED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05041361
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This single-arm intervention trial administers up to 4 bi-weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions to adults aged 18 years or older with major depressive disorder (MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Cognitive Behavioral Therapy (CBT) Device: Whole-Body Hyperthermia (WBH) Not Applicable

Detailed Description:
Major Depressive Disorder afflicts more than 300 million 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 single-arm trial will pilot and optimize procedures for integrating WBH (4 bi -weekly sessions) with CBT (8 weekly sessions). This work holds important promise to improve treatment of depression and advance understanding of the role of integrated mind-body therapies for mood disorders.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Current major depressive episode of at least 4 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Beck Depression Inventory-II (BDI-II) score greater than or equal to 21 at screening
  • Age of at least 18 years old
  • Must have smartphone onto which they can download an app from Apple App or Google Play stores
  • English speaking
  • Ability to lie supine (on back) for 2 hours (required for WBH sessions)
  • Must be fully vaccinated against COVID-19

Exclusion criteria:

  • Greater than 30 percent reduction in BDI-II score between Screen 1 and Screen 2 (conducted about 1 week after Screen 1)
  • Suicide attempt within the prior 12 months and/or severe current suicidal ideation
  • Any of the following medical conditions: cardiovascular disease (other than controlled hypertension), seizure disorder, history of cerebrovascular accident (CVA) or other serious neurological condition (e.g. Parkinson's disease, multiple sclerosis, or dementia), current neoplasia, any active enclosed infection (e.g. dental abscess, joint infection), hemophilia or other cause for excessive bleeding (e.g. platelet disorder, or other medical condition that in the opinion of investigators may increase the risk of WBH)
  • Comorbid psychiatric conditions or history of comorbid psychiatric conditions that might better explain depressive symptoms, including schizophrenia, schizoaffective disorder, Bipolar Disorder I, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Alcohol Dependence, or Drug Dependence
  • Inability to fit into the sauna device
  • Known hypersensitivity to hyperthermia and/or infrared exposure
  • Breast implants
  • Pregnancy, active lactation or intention to become pregnant during the study period

Use of any:

  • Medication that might impact thermoregulatory capacity, including: diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose ASA for prophylactic purposes)
  • Medication prescribed for the treatment of depression (antidepressant medication; ADM) including but not limited to: selective serotonin reuptake inhibitors [SSRIs], Serotonin and norepinephrine reuptake inhibitors (SNRIs), Monoamine oxidase inhibitors (MAOIs), Tricyclics (TCAs) and atypical antipsychotic and antidepressant medications. Participants must have been free of these medications for at least 4 weeks
  • Antibiotics (past 14 days), pain medication (opioids) due to procedure, e.g., dental procedure (past 14 days), emergency contraception pill (past 14 days)
  • Medication that in the judgment of the PI would increase risk of study participation or introduce excessive variance into physiological or behavioral responses to WBH
  • Recent use (multiple consecutive doses) of: non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, cytokine antagonists
  • Greater than 30 percent reduction in Beck Depression Inventory-II (BDI-II) score between Screen 1 and Screen 2
  • Has begun new psychotherapy treatment in the prior 6 weeks
  • Regular use of any nicotine products, including cigarettes, vapes, chewing tobacco, or other forms of nicotine (if use is not regular, must be willing to refrain for 24 hours before and 24 hours after each WBH session)
  • Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after each WBH session
  • Unwilling to refrain from sauna use outside of study procedures during study participation, and must not have used a sauna for more than 20 minutes on any single occasion in the 60 days before the screen 2/baseline study visit, and must not have used a sauna in the 30 days before the screen 2/baseline study visit

Information from the National Library of Medicine

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


Contacts
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Contact: Anoushka Chowdhary, BA 415-514-8445 heatbed@ucsf.edu

Locations
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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         
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Ashley E Mason, PhD University of California, San Francisco
Principal Investigator: Frederick M Hecht, MD University of California, San Francisco
Additional Information:
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05041361    
Other Study ID Numbers: HEATBED
R34AT011221 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperthermia
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries