Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
240 participants
INTERVENTIONAL
2026-06-30
2030-12-31
Brief Summary
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Detailed Description
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This project aims to establish a protocol to deliver WBH therapy to patients with mood and anxiety disorders to collect information about scientific mechanisms. It also seeks to extend treatment to a specific population: a single session WBH treatment could be of tremendous interest to depressed postpartum women who wish to avoid medications and time away from their infants.
The mechanistic work will be completed with the four cohorts. By examining mechanisms in all four groups, investigators will be able to determine mechanisms unique to ill individuals as well as any mechanistic differences between MDD and PPD. In addition, the investigators aim to establish feasibility and acceptability of this protocol in postpartum women. Why? Over 80% of women deliver a child, and 15-20% of all women develop significant postpartum mental illness, usually depression and anxiety.
Participants will be divided into two groups: those undergoing a simplified protocol to test feasibility and acceptability in the postpartum (Study Group 1) and those undergoing a more time-intensive protocol to evaluate mechanisms (Study Group 2). In addition, participants in Study Group 2 will be eligible to enroll in a sub-study (Study Group 3) including up to 10 fMRI session.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 2 - Cohort 2a
Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
Group 2 - Cohort 2b
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
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
Group 2 - Cohort 2c
Healthy adults of both sexes 18-50 years of age
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
Group 2 - Cohort 2d
Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
Group 3 - Cohort 2a
Healthy women or transgender men 18-50 years of age, \<6 months postpartum
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
fMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Group 3 - Cohort 2b
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
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
fMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Group 3 - Cohort 2c
Healthy adults of both sexes 18-50 years of age
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
fMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Group 3 - Cohort 2d
Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the MINI
Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
fMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Interventions
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Whole-Body Hyperthermia
The Clearlight dome sauna is portable infrared sauna consisting of two lightweight domes and an infrared heating pad. The sauna will be used to deliver the intervention to the participant and the sauna session will end as soon as (1) an internal body temperature of 38.5 C (101.3 F) is reached for two consecutive minutes or, (2) 140 minutes have passed.
fMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Arm 1: Healthy women or transgender men 18-50 years of age, ≤ 6 months postpartum
* Arm 2: 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.
* Arm 3: Healthy adults of both sexes 18-50 years of age.
* Arm 4: Adults of both sexes 18-50 years of age meeting criteria for an episode of major depression or generalized anxiety disorder on the Mini International Neuropsychiatric Interview (MINI)
* Study Group 3
Exclusion Criteria
* For contraindications to hyperthermia, we will exclude from all cohorts listed above, individuals with severe cardiovascular disease, including congestive heart failure, coronary artery disease, uncontrolled hypertension, and hypotension; pregnancy; active substance use disorders; recent major injuries or surgeries (\<1 week prior); impaired sweating (those with multiple sclerosis, diabetes mellitus with neuropathy, central nervous system disease, heat insensitivity); a history or family history of malignant hyperthermia, fever or active signs of infection; taking medications that may have interactions with hyperthermia (for example, barbiturates, diuretics, and beta blockers) and the use of an antipyretic or anihistamine medication in the 12 hours prior to the WBH intervention. Individuals with above mentioned conditions will be excluded since either WBH might deteriorate their conditions or it is unknown how their condition will be affected by WBH.
* For contraindications to immune analyses, we will exclude individuals with conditions that might affect immune analyses, including individuals with known active autoimmune or endocrine disease and individuals with active infection at baseline.
* Study Group 2
* Arm 1: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
* Arm 2: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
* Arm 3: For psychiatric contraindications, we will exclude individuals with a history of psychiatric disorders as assessed by MINI since the cohort will consist of mentally healthy individuals as a control group.
* Arm 4: For psychiatric contraindications, we will exclude individuals with bipolar disorder or other Axis I psychiatric disorders except depressive and anxiety disorders and individuals taking antidepressants who are unwilling to hold antidepressant dose steady from recruitment through study termination. In this cohort we exclude individuals with other psychiatric disorders except depressive and anxiety disorders to rule out the effect of other psychiatric diseases on the outcome.
* Study Group 2 and Study Group 3 - All participants
* For contraindications to use of the e-Celsius capsule that will be used to measure core temperature, we will exclude individuals with pacemakers or any other electric medical implant, individuals with a current intestinal disorder that could lead to obstruction of the digestive tract including gastroparesis, individuals with history of diverticula, individuals with history of past surgical procedures in the gastrointestinal tract, individuals with a swallowing disorder and individuals with Crohn's disease.
* Study Group 3 - All participants
* For contraindications to MRI, individuals with metal in the body will be excluded from participating in the MRI portion of the research since magnetic fields in MRI scanners can cause dangerous interactions in patients with metallic foreign bodies: projectile effect, twisting, burning, artifacts, and device malfunction (interference with a pacemaker).
18 Years
50 Years
ALL
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Lauren M Osborne, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Jonathan Power, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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de Labra C, Pardo-Vazquez JL, Cudeiro J, Rivadulla C. Hyperthermia-Induced Changes in EEG of Anesthetized Mice Subjected to Passive Heat Exposure. Front Syst Neurosci. 2021 Sep 9;15:709337. doi: 10.3389/fnsys.2021.709337. eCollection 2021.
Yamane T, Tateishi A, Cho S, Manabe S, Yamanashi M, Dezawa A, Yasukouchi H, Ishioka K. The effects of hyperthermia on the spinal cord. Spine (Phila Pa 1976). 1992 Nov;17(11):1386-91. doi: 10.1097/00007632-199211000-00020.
Haveman J, Geerdink AG, Rodermond HM. Cytokine production after whole body and localized hyperthermia. Int J Hyperthermia. 1996 Nov-Dec;12(6):791-800. doi: 10.3109/02656739609027685.
Landsberg L, Young JB, Leonard WR, Linsenmeier RA, Turek FW. Is obesity associated with lower body temperatures? Core temperature: a forgotten variable in energy balance. Metabolism. 2009 Jun;58(6):871-6. doi: 10.1016/j.metabol.2009.02.017.
Lynch CJ, Power JD, Scult MA, Dubin M, Gunning FM, Liston C. Rapid Precision Functional Mapping of Individuals Using Multi-Echo fMRI. Cell Rep. 2020 Dec 22;33(12):108540. doi: 10.1016/j.celrep.2020.108540.
Newbold DJ, Laumann TO, Hoyt CR, Hampton JM, Montez DF, Raut RV, Ortega M, Mitra A, Nielsen AN, Miller DB, Adeyemo B, Nguyen AL, Scheidter KM, Tanenbaum AB, Van AN, Marek S, Schlaggar BL, Carter AR, Greene DJ, Gordon EM, Raichle ME, Petersen SE, Snyder AZ, Dosenbach NUF. Plasticity and Spontaneous Activity Pulses in Disused Human Brain Circuits. Neuron. 2020 Aug 5;107(3):580-589.e6. doi: 10.1016/j.neuron.2020.05.007. Epub 2020 Jun 16.
Mason AE, Fisher SM, Chowdhary A, Guvva E, Veasna D, Floyd E, Fender SB, Raison C. Feasibility and acceptability of a Whole-Body hyperthermia (WBH) protocol. Int J Hyperthermia. 2021;38(1):1529-1535. doi: 10.1080/02656736.2021.1991010.
Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
Maternal depression and child development. Paediatr Child Health. 2004 Oct;9(8):575-598. doi: 10.1093/pch/9.8.575. No abstract available.
Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
Halligan SL, Murray L, Martins C, Cooper PJ. Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007 Jan;97(1-3):145-54. doi: 10.1016/j.jad.2006.06.010. Epub 2006 Jul 24.
Lyons-Ruth K, Zoll D, Connell D, Grunebaum HU. The depressed mother and her one-year-old infant: environment, interaction, attachment, and infant development. New Dir Child Dev. 1986 Winter;(34):61-82. doi: 10.1002/cd.23219863407. No abstract available.
Murray L. The impact of postnatal depression on infant development. J Child Psychol Psychiatry. 1992 Mar;33(3):543-61. doi: 10.1111/j.1469-7610.1992.tb00890.x.
Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Postpartum depression and mother-infant relationship at 3 months old. J Affect Disord. 2002 Aug;70(3):291-306. doi: 10.1016/s0165-0327(01)00367-6.
Righetti-Veltema M, Bousquet A, Manzano J. Impact of postpartum depressive symptoms on mother and her 18-month-old infant. Eur Child Adolesc Psychiatry. 2003 Apr;12(2):75-83. doi: 10.1007/s00787-003-0311-9.
Field T. Postpartum depression effects on early interactions, parenting, and safety practices: a review. Infant Behav Dev. 2010 Feb;33(1):1-6. doi: 10.1016/j.infbeh.2009.10.005. Epub 2009 Dec 3.
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Weissman MM. Postpartum Depression and Its Long-term Impact on Children: Many New Questions. JAMA Psychiatry. 2018 Mar 1;75(3):227-228. doi: 10.1001/jamapsychiatry.2017.4265. No abstract available.
Societal Costs of Untreated Perinatal Mood and Anxiety Disorders in the United States. Mathematica. Accessed December 1, 2022. https://www.mathematica.org/publications/societal-costs-of-untreated-perinatal-moodand- anxiety-disorders-in-the-united-states
Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
Koltyn KF, Robins HI, Schmitt CL, Cohen JD, Morgan WP. Changes in mood state following whole-body hyperthermia. Int J Hyperthermia. 1992 May-Jun;8(3):305-7. doi: 10.3109/02656739209021785.
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Zschaeck S, Weingartner J, Ghadjar P, Wust P, Mehrhof F, Kalinauskaite G, Ehrhardt VH, Hartmann V, Tinhofer I, Heiland M, Coordes A, Kofla G, Budach V, Stromberger C, Beck M. Fever range whole body hyperthermia for re-irradiation of head and neck squamous cell carcinomas: Final results of a prospective study. Oral Oncol. 2021 May;116:105240. doi: 10.1016/j.oraloncology.2021.105240. Epub 2021 Feb 21.
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Related Links
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Clearlight Sauna Dome
Other Identifiers
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23-01025619
Identifier Type: -
Identifier Source: org_study_id
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