Whole-Body Hyperthermia for Postpartum Depression

Overseen By Lauren M Osborne, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies whole-body hyperthermia (WBH), a treatment using controlled heat exposure, to help improve mood and reduce anxiety. It focuses on women with postpartum depression (PPD) who prefer non-medication treatments. WBH works by affecting the immune system and brain function.

Research Team

Lauren M Osborne, PhD

Principal Investigator

Weill Medical College of Cornell University

Jonathan Power, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for healthy postpartum women or transgender men, and adults with major depression or anxiety disorders. Participants must be aged 18-50, and for postpartum individuals, within 6 months after giving birth. The study excludes anyone outside this age range or not meeting the specific mental health criteria.

Inclusion Criteria

I am a healthy woman or transgender man, aged 18-50, and gave birth within the last 6 months.

Study Group 3: Subjects enrolled in Study Group 2 are eligible for an optional additional sub-study (Study Group 3); inclusion criteria are the same as for Study Group 2

I am a woman or transgender man, aged 18-50, within 6 months postpartum, and have been diagnosed with postpartum depression.

Exclusion Criteria

For logistics, individuals with BMI >30 and waist size > 35 will be excluded from all cohorts

Study Group 3 - All participants: Individuals with metal in the body will be excluded from participating in the MRI portion of the research

Study Group 2: Arm 3 - Individuals with a history of psychiatric disorders as assessed by MINI will be excluded

Treatment Details

Interventions

• Whole-Body Hyperthermia (Behavioural Intervention)

Trial Overview The trial is testing whole-body hyperthermia (WBH) as a treatment for mood and anxiety disorders including postpartum depression. It involves one session of WBH therapy and tracks changes using fMRI scans in various participant groups over time to assess effectiveness.

Participant Groups

Group I: Group 3 - Cohort 2d Experimental Treatment 2 Interventions

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group II: Group 3 - Cohort 2c Experimental Treatment 2 Interventions

Healthy adults of both sexes 18-50 years of age

Group III: Group 3 - Cohort 2b Experimental Treatment 2 Interventions

Women and transgender men 18-50 years of age, \<6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI

Group IV: Group 3 - Cohort 2a Experimental Treatment 2 Interventions

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Group V: Group 2 - Cohort 2d Experimental Treatment 1 Intervention

Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI

Group VI: Group 2 - Cohort 2c Experimental Treatment 1 Intervention

Healthy adults of both sexes 18-50 years of age

Group VII: Group 2 - Cohort 2b Experimental Treatment 1 Intervention

Women and transgender men 18-50 years of age, \<6 months postpartum, meeting criteria for a major depressive episode in the postpartum period on the MINI

Group VIII: Group 2 - Cohort 2a Experimental Treatment 1 Intervention

Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+