Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Ashley E Mason, PhDFrederick M Hecht, MD
Photo of Ashley E Mason
Ashley E Mason
Photo of Frederick M Hecht
Frederick M Hecht

Description

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).

Official Title

HypErthermia as an Additional Treatment for the Biology and Experience of Depression: The HEAT BED Study

Details

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.

Keywords

Major Depressive Disorder Hyperthermia Depressive Disorder Depressive Disorder, Major Cognitive Behavioral Therapy (CBT) Whole-Body Hyperthermia (WBH) Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • >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

Location

  • University of California San Francisco
    San Francisco California 94115 United States

Lead Scientists at UCSF

  • Ashley E Mason, PhD
    Associate Professor, Psychiatry. Authored (or co-authored) 50 research publications. Research interests: Non-pharmacologic interventions for depression and insomnia · Food-craving experiences · Reward-based eating · Stress-induced Eating · Ketogenic diets for Type 2 Diabetes · Sleep problems · Prediabetes · Type 2 diabetes · Endogenous opioidergic activity · Opioidergic blockade · Insomnia
  • Frederick M Hecht, MD
    I am trained in Internal Medicine, with additional training in clinical research methods, biostatistics, and behavioral medicine. My research focus for many years was on HIV.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Access to e-screen for interested prospective participants
ID
NCT05041361
Study Type
Interventional
Last Updated