240 Participants Needed

Whole-Body Hyperthermia for Postpartum Depression

RS
RP
LM
Overseen ByLauren M Osborne, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it does mention that participants taking antidepressants must keep their dose steady throughout the study. Additionally, if you are taking medications like barbiturates, diuretics, or beta blockers, you may be excluded due to potential interactions with the treatment.

Is whole-body hyperthermia safe for humans?

Whole-body hyperthermia has been used in cancer treatment and can cause side effects like fatigue, nausea, diarrhea, and changes in heart and liver function. While it can be safe under careful monitoring, it has potential risks, including serious toxicity and, in rare cases, fatalities.12345

How does whole-body hyperthermia treatment differ from other treatments for postpartum depression?

Whole-body hyperthermia (WBH) is a unique treatment for postpartum depression as it involves raising the body's core temperature using infrared heating, unlike standard treatments like psychotherapy and antidepressant medications. This non-drug approach is promising for depression with low risk of side effects, but it still requires more evidence for widespread clinical use.678910

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

LM

Lauren M Osborne, PhD

Principal Investigator

Weill Medical College of Cornell University

JP

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

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

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
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a single session of whole-body hyperthermia (WBH) therapy to examine scientific mechanisms and assess feasibility and acceptability

1 session
1 visit (in-person)

Follow-up

Participants are monitored for changes in core temperature, inflammatory activity, and neural circuit activity post-intervention

6 weeks
Up to 7 fMRI scans and multiple assessments

Treatment Details

Interventions

  • Whole-Body Hyperthermia
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
8Treatment groups
Experimental Treatment
Group I: Group 3 - Cohort 2dExperimental Treatment2 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 2cExperimental Treatment2 Interventions
Healthy adults of both sexes 18-50 years of age
Group III: Group 3 - Cohort 2bExperimental Treatment2 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 2aExperimental Treatment2 Interventions
Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Group V: Group 2 - Cohort 2dExperimental Treatment1 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 2cExperimental Treatment1 Intervention
Healthy adults of both sexes 18-50 years of age
Group VII: Group 2 - Cohort 2bExperimental Treatment1 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 2aExperimental Treatment1 Intervention
Healthy women or transgender men 18-50 years of age, \<6 months postpartum

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Findings from Research

A single session of whole-body hyperthermia (WBH) using a commercially available infrared sauna successfully raised participants' core body temperature to 101.3°F, which is associated with reduced depressive symptoms in previous studies.
Participants reported significant reductions in self-reported negative affect and depression symptoms from one week before to one week after the WBH session, suggesting that this non-pharmacologic treatment may be effective for major depressive disorder.
Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol.Mason, AE., Fisher, SM., Chowdhary, A., et al.[2022]
Whole-body hyperthermia (WBH) has shown promising effects on mood and depression symptoms, with 19 out of 21 study endpoints demonstrating significant effect sizes (Cohen's d of 0.8 or greater) across 7 studies involving 148 participants.
WBH interventions, which included hot baths and infrared heating, were generally safe with low risk of adverse reactions, but the evidence is still insufficient for broad clinical recommendations, highlighting the need for further research.
The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application?Hanusch, KU., Janssen, CW.[2019]

References

Aspects of thermoregulatory physiology pertinent to hyperthermic treatment of cancer. [2008]
Physiologic response and toxicity in patients undergoing whole-body hyperthermia for the treatment of cancer. [2013]
Whole-body hyperthermia in cancer therapy: a report of a phase I-II study. [2019]
Whole body hyperthermia: a phase-I trial of a potential adjuvant to chemotherapy. [2022]
Systemic thermotherapy (whole body hyperthermia). [2016]
Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. [2022]
The impact of whole-body hyperthermia interventions on mood and depression - are we ready for recommendations for clinical application? [2019]
Management of postpartum depression. [2021]
Postpartum depression screening scale: Spanish version. [2021]
Magnetic Resonance Imaging Studies of Postpartum Depression: An Overview. [2022]
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