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

NCT05041361 | Completed Results DMC FDA Device

• 2 other identifiers: HEATBEDR34AT011221
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm feasibility trial administered up to 8 weekly (early phase) or 4 bi-weekly (later phase) 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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Average Number of Planned WBH Sessions Completed

  Investigators will average and report the number of completed WBH sessions (4 bi-weekly WBH sessions or 8 weekly WBH sessions offered to participants).

  12 weeks

Secondary Outcomes (2)

• Average Number of Planned Beck Depression Inventory-II (BDI-II) Assessments Completed

  12 weeks

• Change in Beck Depression Inventory-II (BDI-II) From Baseline to 12-week Assessment

  Baseline and 12 weeks

Study Arms (1)

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

EXPERIMENTAL

Participants receive up to 8 weekly (early phase) or 4 bi-weekly (later phase) 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); Device: Whole-Body Hyperthermia (WBH)

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.

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

Whole-Body Hyperthermia (WBH) DEVICE

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.

Also known as: Sauna Sessions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (2)

• 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.

  PMID: 27172277 BACKGROUND

• 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. No abstract available.

  PMID: 23820835 BACKGROUND

Related Links

• Access to e-screen for interested prospective participants

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions (n=6 participants) were reduced to 4 bi-weekly WBH sessions (n=10 participants) to improve feasibility.

Results Point of Contact

• Title: Ashley Mason, PhD
• Organization: University of California, San Francisco

ashley.mason@ucsf.edu

415 514 6820

Study Officials

• Ashley E Mason, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Frederick M Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: October 11, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)