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

• ClinicalTrials.gov Identifier: NCT05041361
• Recruitment Status: Recruiting
• First Posted: September 13, 2021
• Last Update Posted: October 14, 2021
• Sponsor: University of California, San Francisco
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: September 2, 2021
• First Posted Date: September 13, 2021
• Last Update Posted Date: October 14, 2021
• Actual Study Start Date: October 11, 2021
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 2, 2021)

Average Number of Planned WBH Sessions Completed [ Time Frame: 12 weeks ]

Investigators will average and report the number of completed WBH sessions (8 WBH sessions planned per participant).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 2, 2021)

• 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 WBH sessions (10 BDI-II assessments 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HypErthermia as an Additional Treatment for the Biology and Experience of Depression
• Official Title: HypErthermia as an Additional Treatment for the Biology and Experience of Depression: The HEAT BED Study
• Brief Summary: This single-arm intervention trial administers up to 8 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).
• 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 (8 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• 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 2.5 hours, with active WBH lasting up to approximately 80 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

Study Arms

Experimental: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH)

Participants receive up to 8 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 2.5 hours, and each CBT session is approximately 50 minutes.

Interventions:

• Behavioral: Cognitive Behavioral Therapy (CBT)
• Device: Whole-Body Hyperthermia (WBH)

Publications *

• Janssen CW, Lowry CA, Mehl MR, Allen JJ, Kelly KL, Gartner DE, Medrano A, Begay TK, Rentscher K, White JJ, Fridman A, Roberts LJ, Robbins ML, Hanusch KU, Cole SP, Raison CL. Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Aug 1;73(8):789-95. doi: 10.1001/jamapsychiatry.2016.1031. Erratum in: JAMA Psychiatry. 2016 Aug 1;73(8):878.
• Hanusch KU, Janssen CH, Billheimer D, Jenkins I, Spurgeon E, Lowry CA, Raison CL. Whole-body hyperthermia for the treatment of major depression: associations with thermoregulatory cooling. Am J Psychiatry. 2013 Jul;170(7):802-4. doi: 10.1176/appi.ajp.2013.12111395.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 2, 2021): 16
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 30, 2023
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age of at least 18 years old.
• Current major depressive episode of at least 4 weeks duration as assessed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (SCID) and a Beck Depression Inventory-II (BDI-II) score > 21 at screening
• Waist size less than or equal to 40 inches for men or 35 inches for women and a BMI less than or equal to 35
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures
• Must have smartphone onto which they can download an app from Apple App or Google Play stores Ability to lie supine (on back) for 2 hours (required for sauna sessions)
• Must be fully vaccinated against COVID-19

Exclusion Criteria:

• >30% reduction in BDI-II score between Screen #1 and Screen #2 (conducted ~1 week after Screen #1) Suicide attempt within the prior 12 months and/or active current suicidal ideation defined using the Substance Abuse and Mental Health Services Administration suicidality questions during the clinician-administered interview
• 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
• Known hypersensitivity to hyperthermia and/or infrared exposure
• Inability to fit into the sauna device
• 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 aspirin for prophylactic purposes), medication prescribed for the treatment of depression (antidepressant medication including but not limited to: selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors , Monoamine oxidase inhibitors, Tricyclics, 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), any other 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, systemic corticosteroids, cytokine antagonists
• 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 WBH session)
• Unwilling to refrain from using marijuana products and alcohol for the 24 hours before and 24 hours after WBH session
• Unwilling to refrain from heavy exercise on the day of WBH sessions
• Unwilling to refrain from sauna use outside of study procedures during study participation
• Has begun new psychotherapy treatment in the prior 6 weeks

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05041361
• Other Study ID Numbers: HEATBED; R34AT011221 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Ashley E Mason, PhD; University of California, San Francisco
• Principal Investigator: Frederick M Hecht, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2021