Trial Outcomes & Findings for HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2 (NCT NCT05708976)
NCT ID: NCT05708976
Last Updated: 2025-10-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2
Baseline characteristics by cohort
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.47 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
35.87 years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
38.17 years
STANDARD_DEVIATION 13.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unreported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Education (highest level completed)
High School diploma or GED
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education (highest level completed)
Some college
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education (highest level completed)
Associate's Degree
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education (highest level completed)
Bachelor's Degree
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education (highest level completed)
Master's Degree
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education (highest level completed)
Professional Degree (e.g., MD, DDS, JD)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education (highest level completed)
Doctoral Degree (e.g., PhD, EdD)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI), Kg/m^2
|
27.12 kg/m^2 (kilograms per meter-squared)
STANDARD_DEVIATION 6.45 • n=5 Participants
|
25.93 kg/m^2 (kilograms per meter-squared)
STANDARD_DEVIATION 5.54 • n=7 Participants
|
26.53 kg/m^2 (kilograms per meter-squared)
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Blood Pressure (SBP/DBP), mm Hg
Systolic Blood Pressure
|
114.2 mm Hg
STANDARD_DEVIATION 14.2 • n=5 Participants
|
113.0 mm Hg
STANDARD_DEVIATION 17.2 • n=7 Participants
|
113.6 mm Hg
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Blood Pressure (SBP/DBP), mm Hg
Diastolic Blood Pressure
|
76.3 mm Hg
STANDARD_DEVIATION 8.6 • n=5 Participants
|
78.7 mm Hg
STANDARD_DEVIATION 8.6 • n=7 Participants
|
77.5 mm Hg
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Beck Depression Inventory II (BDI-II)
|
32.73 Score on a scale
STANDARD_DEVIATION 9.07 • n=5 Participants
|
32.27 Score on a scale
STANDARD_DEVIATION 7.76 • n=7 Participants
|
32.50 Score on a scale
STANDARD_DEVIATION 8.30 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study participants who completed the final study survey, Net Promoter Score
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).
Outcome measures
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=14 Participants
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.
|
|---|---|---|
|
Net Promoter Score, and Enrollment Likelihood
Net Promoter Score (0-10)
|
7.73 score on a scale
Standard Deviation 2.15
|
8.00 score on a scale
Standard Deviation 2.08
|
|
Net Promoter Score, and Enrollment Likelihood
Enrollment Likelihood (1-5)
|
4.13 score on a scale
Standard Deviation 1.06
|
4.29 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange 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.
Outcome measures
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=14 Participants
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.
|
|---|---|---|
|
Change in Beck Depression Inventory-II (BDI-II)
|
-19.07 score on a scale
Standard Error 2.69
|
-21.10 score on a scale
Standard Error 2.41
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange 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.
Outcome measures
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=14 Participants
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.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 8a Depression
|
-10.79 T-score units
Standard Error 2.66
|
-11.54 T-score units
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange 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.
Outcome measures
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=14 Participants
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.
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report
|
-6.42 score on a scale
Standard Error 1.30
|
-7.16 score on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange 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.
Outcome measures
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 Participants
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=14 Participants
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.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety
|
-7.24 T-score units
Standard Error 1.63
|
-7.51 T-score units
Standard Error 2.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-3 weeksSudden 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
Outcome measures
Outcome data not reported
Adverse Events
Active Whole-body Hyperthermia (Active Treatment)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sham Whole-body Hyperthermia (Sham Treatment)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Whole-body Hyperthermia (Active Treatment)
n=15 participants at risk
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.
|
Sham Whole-body Hyperthermia (Sham Treatment)
n=15 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
86.7%
13/15 • Number of events 28 • 12 weeks
|
20.0%
3/15 • Number of events 6 • 12 weeks
|
|
General disorders
Lightheadedness
|
46.7%
7/15 • Number of events 15 • 12 weeks
|
13.3%
2/15 • Number of events 3 • 12 weeks
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 2 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 8 • 12 weeks
|
13.3%
2/15 • Number of events 2 • 12 weeks
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 2 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Blood and lymphatic system disorders
Bruising
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
General disorders
Sleep Disturbance
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
General disorders
Head Pressure
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
General disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Infections and infestations
Flu
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Surgical and medical procedures
Knee surgery
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
Additional Information
Ashley E. Mason, PhD
University of California San Francisco
Phone: 4155146820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place