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HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2 (HEATBED2)

Primary Purpose

Major Depressive Disorder, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Active Whole-Body Hyperthermia (Active WBH)
Sham Whole-Body Hyperthermia (Sham WBH)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring hyperthermia, heat therapy, passive heating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age of at least 18 years old Current major depressive episode of at least 2 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Beck Depression Inventory-II (BDIII) score > 21 at screening 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 the participant can download an app from Apple App or Google Play stores Ability to lie supine (on back) for 2 hours (required for sauna sessions) Exclusion Criteria: >30% reduction in BDI-II score between Screen #1 and Screen #2 (conducted ~1 week after Screen #1) Suicide attempt in the past 12 months defined using the SAMHSA suicidality question during the clinician-administered interview or active suicidal ideation as indexed by a score of 3 on the BDI-II suicidality item 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 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) 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 (NSAIDs), 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 engaging with sauna, hot yoga, cold plunges, cryotherapy, and hot tub/jacuzzi outside of study (prospective participant must not have engaged with any of these activities for 30 days prior to their baseline study visit). Has begun new psychotherapy treatment in the prior 6 weeks

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Whole-body Hyperthermia (Active Treatment)

Sham Whole-body Hyperthermia (Sham Treatment)

Arm Description

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each active WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly sham whole-body hyperthermia (WBH) sessions, which minimally raise body temperature. Each sham WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Outcomes

Primary Outcome Measures

Net Promoter Score
Study acceptability will be indexed by participant-reported net-promoter scores. This is a response to a single question: "How likely would you be to recommend [participation in a study or treatment like this] to a friend or family member with depression?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend).

Secondary Outcome Measures

Change in Beck Depression Inventory-II (BDI-II)
Change in BDI-II from baseline assessment to final assessment. Scores range from 0 to 63 and items are summed to create a total score; higher scores indicate greater depression symptoms.
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression
Change in PROMIS8a Depression from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms.
Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report
Change in HAMD-6 from baseline to final assessment. Scores range from 0 to 22, and items are summed to create a total score; higher scores indicate greater depression symptoms.
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety
Change in PROMIS4a Anxiety from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms.

Full Information

First Posted
January 23, 2023
Last Updated
May 22, 2023
Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05708976
Brief Title
HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2
Acronym
HEATBED2
Official Title
HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized two-arm intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly active whole-body hyperthermia (active WBH) sessions or 4 bi-weekly sham WBH 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 active WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This randomized two-arm trial will pilot and optimize procedures for randomizing participants to receive CBT (8 weekly sessions) and 4 bi-weekly whole-body hyperthermia (active WBH) or 4 bi-weekly sham WBH 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression
Keywords
hyperthermia, heat therapy, passive heating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two study arms
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Study clinicians, who perform clinical interviews and provide cognitive behavioral therapy (CBT) treatments, will be masked to participant condition.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Whole-body Hyperthermia (Active Treatment)
Arm Type
Experimental
Arm Description
Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each active WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.
Arm Title
Sham Whole-body Hyperthermia (Sham Treatment)
Arm Type
Placebo Comparator
Arm Description
Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly sham whole-body hyperthermia (WBH) sessions, which minimally raise body temperature. Each sham WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active Whole-Body Hyperthermia (Active WBH)
Other Intervention Name(s)
Active Sauna Sessions
Intervention Description
Active whole-body hyperthermia (active WBH) will be administered by trained research assistants. Preparation for the active WBH session, the active WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment 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 38.5 C.
Intervention Type
Device
Intervention Name(s)
Sham Whole-Body Hyperthermia (Sham WBH)
Other Intervention Name(s)
Sham Sauna Sessions
Intervention Description
Sham whole-body hyperthermia (sham WBH) will be administered by trained research assistants. Preparation for the sham WBH session, the sham WBH session, and cool down will last 3.5 hours, with heating lasting approximately 90-100 minutes (and no longer than 140 minutes). The treatment will take place in an infrared sauna dome, and the sham WBH session will minimally impact core body temperature.
Primary Outcome Measure Information:
Title
Net Promoter Score
Description
Study acceptability will be indexed by participant-reported net-promoter scores. This is a response to a single question: "How likely would you be to recommend [participation in a study or treatment like this] to a friend or family member with depression?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory-II (BDI-II)
Description
Change in BDI-II from baseline assessment to final assessment. Scores range from 0 to 63 and items are summed to create a total score; higher scores indicate greater depression symptoms.
Time Frame
Baseline and 12 weeks
Title
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression
Description
Change in PROMIS8a Depression from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms.
Time Frame
Baseline and 12 weeks
Title
Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report
Description
Change in HAMD-6 from baseline to final assessment. Scores range from 0 to 22, and items are summed to create a total score; higher scores indicate greater depression symptoms.
Time Frame
Baseline and 12 weeks
Title
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety
Description
Change in PROMIS4a Anxiety from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Sudden gains in antidepressant responses
Description
Sudden gain in BDI-II scores, defined as >25% reduction in depression symptoms in between between two adjacent sauna sessions, account for more than 50% of total depression symptom improvement
Time Frame
2-3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of at least 18 years old Current major depressive episode of at least 2 weeks duration as assessed by the Structured Clinical Interview for DSM-5 (SCID) and a Beck Depression Inventory-II (BDIII) score > 21 at screening 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 the participant can download an app from Apple App or Google Play stores Ability to lie supine (on back) for 2 hours (required for sauna sessions) Exclusion Criteria: >30% reduction in BDI-II score between Screen #1 and Screen #2 (conducted ~1 week after Screen #1) Suicide attempt in the past 12 months defined using the SAMHSA suicidality question during the clinician-administered interview or active suicidal ideation as indexed by a score of 3 on the BDI-II suicidality item 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 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) 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 (NSAIDs), 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 engaging with sauna, hot yoga, cold plunges, cryotherapy, and hot tub/jacuzzi outside of study (prospective participant must not have engaged with any of these activities for 30 days prior to their baseline study visit). Has begun new psychotherapy treatment in the prior 6 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anoushka Chowdhary, BA
Phone
415 514 8445
Email
heatbed@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claudine Anglo, BS
Phone
415 514 8445
Email
heatbed@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley E Mason, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederick M Hecht, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anoushka Chowdhary, BA
Phone
415-514-8445
Email
HEATBED@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Ashley E Mason, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34674592
Citation
Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
Results Reference
background
PubMed Identifier
27172277
Citation
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.
Results Reference
background
PubMed Identifier
23820835
Citation
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.
Results Reference
background
Links:
URL
https://www.sealab.ucsf.edu/heatbedstudy
Description
Access to initial online screening for interested prospective participants

Learn more about this trial

HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2

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