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CBT + Hyperthermia for Depression

Not yet recruiting at 2 trial locations
AE
SM
Overseen BySarah M Fisher, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must not be taking: Antidepressants, Antipsychotics, Diuretics, others
Disqualifiers: Cardiovascular disease, Seizure disorder, Schizophrenia, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized 2x2 factorial intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions (yes/no) and 4 bi-weekly active whole-body hyperthermia (WBH) sessions (yes/no) to adults aged 18 years or older with major depressive disorder (MDD).

Who Is on the Research Team?

AE

Ashley E Mason, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who currently have major depression lasting at least two weeks, can read and speak English, are able to use the internet, and can lie down in a sauna device for up to 2 hours. Women of childbearing age must agree to use birth control.

Inclusion Criteria

Able to read and speak in English
Access to the internet via computer, smartphone, or tablet
I am 18 years old or older.
See 4 more

Exclusion Criteria

Unwillingness to refrain from marijuana and alcohol for 24 hours before and after WBH session
Comorbid psychiatric conditions that might better explain depressive symptoms including schizophrenia, schizoaffective disorder, Bipolar Disorder I, OCD, Anorexia Nervosa, Bulimia Nervosa, Alcohol or Drug Dependence
Known hypersensitivity to hyperthermia and/or infrared exposure
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions

8 weeks
8 CBT visits (in-person), 4 WBH visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Post-intervention assessments

Long-term follow-up

Participants complete study assessments including weekly surveys and follow-up assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Whole-Body Hyperthermia

Trial Overview

The study tests if combining cognitive behavioral therapy (CBT) with whole-body hyperthermia (WBH), either alone or together, helps treat major depressive disorder. Participants are randomly assigned to receive CBT sessions, WBH sessions, both treatments, or neither.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: WBH and CBTExperimental Treatment2 Interventions
Group II: WBH OnlyExperimental Treatment1 Intervention
Group III: CBT OnlyExperimental Treatment1 Intervention
Group IV: No InterventionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

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