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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT011221 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Whole-body Hyperthermia (Active Treatment) | Experimental | 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. |
|
| Sham Whole-body Hyperthermia (Sham Treatment) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Net Promoter Score, and Enrollment Likelihood | Study acceptability was 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). Study acceptability was also indexed by an additional patient-reported metric, Enrollment Likelihood. Enrollment likelihood was a response to the question: "How likely would you be to enroll in this study given your experience in this study?" and response options range from 1 (extremely unlikely) to 5 (extremely likely). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression |
| Measure | Description | Time Frame |
|---|---|---|
| Sudden Gains in Antidepressant Responses | 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 | 2-3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley E Mason, PhD | University of California, San Francisco | Principal Investigator |
| Frederick M Hecht, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34674592 | Background | 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. | |
| 27172277 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Whole-body Hyperthermia (Active Treatment) | 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. 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. Active Whole-Body Hyperthermia (Active WBH): 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2025 |
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Participants are randomized to one of two study arms
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Study clinicians, who perform clinical interviews and provide cognitive behavioral therapy (CBT) treatments, will be masked to participant condition.
|
| Active Whole-Body Hyperthermia (Active WBH) | Device | 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. |
|
|
| Sham Whole-Body Hyperthermia (Sham WBH) | Device | 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. |
|
|
Change in PROMIS8a Depression from baseline to final assessment. T scores are computed; higher scores indicate greater depression symptoms. A T-score of 60 indicates sub-clinical or elevated levels of depression. A T score of 50 indicates the population mean with a standard deviation of 10. |
| Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| 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. A T-score of 60 indicates sub-clinical or elevated levels of anxiety. A T score of 50 indicates the population mean with a standard deviation of 10. | Baseline and 12 weeks |
| 23820835 | 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. |
| 41146956 | Result | Mason AE, Hartogensis W, Chowdhary A, Siwik CJ, Pandya LS, Jung E, Lupesko-Persky O, Hartley E, Hopkins L, Roberts S, Borovinsky J, Nelson JC, Lowry CA, Patrick RP, Moran PJ, Raison CL, Hecht FM. A Randomized Trial Testing a Novel Mind and Body Intervention for Depression: Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH). Glob Adv Integr Med Health. 2025 Oct 22;14:27536130251387714. doi: 10.1177/27536130251387714. eCollection 2025 Jan-Dec. |
| 38743265 | Derived | Mason AE, Chowdhary A, Hartogensis W, Siwik CJ, Lupesko-Persky O, Pandya LS, Roberts S, Anglo C, Moran PJ, Nelson JC, Lowry CA, Patrick RP, Raison CL, Hecht FM. Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT). Int J Hyperthermia. 2024;41(1):2351459. doi: 10.1080/02656736.2024.2351459. Epub 2024 May 14. |
| FG001 | Sham Whole-body Hyperthermia (Sham Treatment) | 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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Whole-body Hyperthermia (Active Treatment) | 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. 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. Active Whole-Body Hyperthermia (Active WBH): 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. |
| BG001 | Sham Whole-body Hyperthermia (Sham Treatment) | 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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Education (highest level completed) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI), Kg/m^2 | Mean | Standard Deviation | kg/m^2 (kilograms per meter-squared) |
| |||||||||||||||
| Blood Pressure (SBP/DBP), mm Hg | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Beck Depression Inventory II (BDI-II) | Scores range from 0 to 63 and items are summed to create a total score; higher scores indicate greater depression symptoms. | Mean | Standard Deviation | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Promoter Score, and Enrollment Likelihood | Study acceptability was 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). Study acceptability was also indexed by an additional patient-reported metric, Enrollment Likelihood. Enrollment likelihood was a response to the question: "How likely would you be to enroll in this study given your experience in this study?" and response options range from 1 (extremely unlikely) to 5 (extremely likely). | Study participants who completed the final study survey, Net Promoter Score | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. A T-score of 60 indicates sub-clinical or elevated levels of depression. A T score of 50 indicates the population mean with a standard deviation of 10. | Posted | Mean | Standard Error | T-score units | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. A T-score of 60 indicates sub-clinical or elevated levels of anxiety. A T score of 50 indicates the population mean with a standard deviation of 10. | Posted | Mean | Standard Error | T-score units | Baseline and 12 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Sudden Gains in Antidepressant Responses | 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 | Not Posted | 2-3 weeks | Participants |
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Whole-body Hyperthermia (Active Treatment) | 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. 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. Active Whole-Body Hyperthermia (Active WBH): 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. | 0 | 15 | 0 | 15 | 14 | 15 |
| EG001 | Sham Whole-body Hyperthermia (Sham Treatment) | 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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. | 0 | 15 | 0 | 15 | 6 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | Headache |
| |
| Lightheadedness | General disorders | Systematic Assessment | Lightheadedness |
| |
| Migraine | Nervous system disorders | Systematic Assessment | Migraine |
| |
| Nausea | Gastrointestinal disorders | Systematic Assessment | Nausea |
| |
| Fatigue | General disorders | Non-systematic Assessment | Fatigue |
| |
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Emesis |
| |
| Bruising | Blood and lymphatic system disorders | Non-systematic Assessment | Bruising |
| |
| Sleep Disturbance | General disorders | Non-systematic Assessment | Sleep Disturbance |
| |
| Head Pressure | General disorders | Non-systematic Assessment | Head Pressure |
| |
| Chills | General disorders | Non-systematic Assessment | Chills |
| |
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment | Stomach pain |
| |
| Dry mouth | General disorders | Non-systematic Assessment | Dry mouth |
| |
| Flu | Infections and infestations | Non-systematic Assessment | Flu |
| |
| Knee surgery | Surgical and medical procedures | Non-systematic Assessment | Knee surgery |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley E. Mason, PhD | University of California San Francisco | 4155146820 | ashley.mason@ucsf.edu |
| Sep 26, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2024 | Sep 30, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
|
| Asian |
|
| Latino/Hispanic |
|
| White/Caucasian |
|
| More than one race |
|
| Unreported |
|
| Some college |
|
| Associate's Degree |
|
| Bachelor's Degree |
|
| Master's Degree |
|
| Professional Degree (e.g., MD, DDS, JD) |
|
| Doctoral Degree (e.g., PhD, EdD) |
|
| Diastolic Blood Pressure |
|
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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
|
|
| OG001 |
| Sham Whole-body Hyperthermia (Sham Treatment) |
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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
|
|
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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
|
|
| OG001 |
| Sham Whole-body Hyperthermia (Sham Treatment) |
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. 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. Sham Whole-Body Hyperthermia (Sham WBH): 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. |
|
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