Trial Outcomes & Findings for HypErthermia as an Additional Treatment for the Biology and Experience of Depression (NCT NCT05041361)
NCT ID: NCT05041361
Last Updated: 2024-06-12
Results Overview
Investigators will average and report the number of completed WBH sessions (4 bi-weekly WBH sessions or 8 weekly WBH sessions offered to participants).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-06-12
Participant Flow
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.
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
Participants receive up to 8 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasts until participants achieved a core (rectal) temperature of 101.3 F.
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.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
Participants receive up to 4 bi-weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH takes place in an infrared sauna dome, and the active heating phase lasts until participants achieved a core (rectal) temperature of 101.3 F.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
Participants receive up to 8 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasts until participants achieved a core (rectal) temperature of 101.3 F.
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.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
Participants receive up to 4 bi-weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH takes place in an infrared sauna dome, and the active heating phase lasts until participants achieved a core (rectal) temperature of 101.3 F.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
HypErthermia as an Additional Treatment for the Biology and Experience of Depression
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
n=6 Participants
Participants receive up to 8 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH takes place in an infrared sauna dome, and the active heating phase lasts until participants achieve a core (rectal) temperature of 101.3 F.
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.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia
n=10 Participants
Participants receive up to 4 bi-weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasts 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH takes place in an infrared sauna dome, and the active heating phase lasts until participants achieve a core (rectal) temperature of 101.3 F.
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
27.83 units on a scale
STANDARD_DEVIATION 2.93 • n=5 Participants
|
30.40 units on a scale
STANDARD_DEVIATION 6.64 • n=7 Participants
|
29.44 units on a scale
STANDARD_DEVIATION 5.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This feasibility trial piloted and optimized procedures for integrating WBH. The study was planned to be single-arm, but midway through this 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 are here presented separately by number of WBH sessions offered.
Investigators will average and report the number of completed WBH sessions (4 bi-weekly WBH sessions or 8 weekly WBH sessions offered to participants).
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
n=6 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 8 weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
n=10 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 4 bi-weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
|---|---|---|
|
Average Number of Planned WBH Sessions Completed
|
7.83 Count of WBH Sessions
Standard Deviation 0.41
|
3.20 Count of WBH Sessions
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants were offered 8 CBT sessions and administered 10 BDI-II assessments. This feasibility trial piloted and optimized procedures for integrating WBH. The study was planned to be single-arm, but midway through this 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 are here presented separately by number of WBH sessions offered.
Investigators will average and report the number of completed BDI-II assessments (10 planned per participant)
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
n=6 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 8 weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
n=10 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 4 bi-weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
|---|---|---|
|
Average Number of Planned Beck Depression Inventory-II (BDI-II) Assessments Completed
|
9.3 Assessments Completed
Standard Deviation 1.6
|
8.7 Assessments Completed
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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. All participants were offered 8 CBT sessions and 10 BDI-II assessments. n=6 offered 8 WBH sessions: n=5 completed the final assessment n=10 offered 4 WBH sessions: n=7 completed the final assessment
Change in BDI-II from baseline assessment to final assessment. BDI-II scores range from 0 to 63 with higher scores indicating more severe depression symptoms.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
n=5 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 8 weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
n=7 Participants
Midway through this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.
These results are for participants offered 4 bi-weekly WBH sessions.
Each WBH session (including preparation and cool down) was up to approximately 3.5-4 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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
|
|---|---|---|
|
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 12-week Assessment
|
-16.80 score on a scale
Interval -27.2 to -6.4
|
-15.14 score on a scale
Interval -25.39 to -4.89
|
Adverse Events
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
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 |
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH)
n=6 participants at risk
Participants received up to 8 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
|
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH)
n=10 participants at risk
Participants received up to 4 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions.
Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F.
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 administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
|
|---|---|---|
|
General disorders
Lightheadedness
|
83.3%
5/6 • Number of events 15 • 12 weeks
|
30.0%
3/10 • Number of events 4 • 12 weeks
|
|
General disorders
Headache
|
33.3%
2/6 • Number of events 4 • 12 weeks
|
20.0%
2/10 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 4 • 12 weeks
|
20.0%
2/10 • Number of events 4 • 12 weeks
|
|
General disorders
Jitteriness
|
16.7%
1/6 • Number of events 4 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Migraine
|
16.7%
1/6 • Number of events 2 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
General disorders
Heat Rash
|
16.7%
1/6 • Number of events 2 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Heart Palpitations
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
General disorders
Shin Pain
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Tingling in arms and legs
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Tinnitus
|
0.00%
0/6 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Gastrointestinal disorders
Loose Bowels
|
0.00%
0/6 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
General disorders
Nighttime overheating and body pain
|
0.00%
0/6 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
Additional Information
Ashley Mason, PhD
University of California, San Francisco
Phone: 415 514 6820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place