Anxiety Disorders, Mood Disorders, Postpartum Anxiety, Postpartum Depression
Conditions
Keywords
postpartum depression, mood disorders, anxiety disorders, postpartum anxiety, whole-body hyperthermia, antidepressant therapy, anxiolytic therapy, postpartum feasibility and acceptability, psychoneuroimmunology, Broad-band neural suppression, EEG, Likert scale, inflammatory activity, pro-inflammatory cytokines, precision functional brain maps, fMRI
Brief summary
This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.
Detailed description
Whole-body hyperthermia has already been shown to be feasible, acceptable, and effective in major depressive disorder (MDD) populations, with an open-label study and a subsequent randomized, double-blind, sham-controlled study both demonstrating efficacy. Some evidence indicates that the antidepressant effect may be due to immune mechanisms, though it may also be mediated through direct neural effects of hyperthermia 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 (Group 1) and those undergoing a more time-intensive protocol to evaluate mechanisms (Group 2). In addition, participants in Group 2 will be eligible to enroll in a sub-study (Group 2: Sub-Study) including up to 10 fMRI session.
Interventions
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.
DIAGNOSTIC_TESTfMRI
A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Group 2 * 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) * Group 2: Sub-study * Subjects enrolled in Group 2 are eligible for an optional additional sub-study (Group 2: Sub-study); inclusion criteria are the same as for Group 2.
Exclusion criteria
for all: * For logistics, we will exclude individuals with BMI \>30 and waist size \> 35, who may not fit comfortably in the sauna dome for all cohorts described above. * 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. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in EEG amplitude. | During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed. | Measure the extent of broad-band neural suppression in WBH. |
| Percent change in EEG frequency. | During the course of the intervention: when participant core temperature reaches 38.5 C for two consecutive minutes OR after 140 minutes have passed. | Measure the extent of broad-band neural suppression in WBH, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in inflammatory activity as measured by pro-inflammatory cytokines. | Two days prior to the intervention; immediately prior to intervention; immediately post-intervention; and at five days post-intervention. | Determine whether peripheral immune activation predicts the effect of WBH on PPD or depressive and anxiety symptoms in non-postpartum adults. |
| Mean change in average 24-hour core temperature. | Two days prior to the intervention and five days post-intervention. | Determine the average change in core temperature across the whole-body hyperthermia intervention. |
| Individualized precision functional brain maps. | Up to 3 fMRI scans in the 10 days before the intervention and up to 7 fMRI scans in the 6 weeks post-intervention. | Determine longitudinal changes in neural circuit activity produced by whole-body hyperthermia. |
Countries
United States
Contacts
CONTACTResearch Specialist
CONTACTResearch Program Manager
PRINCIPAL_INVESTIGATORLauren M Osborne, MD
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORJonathan Power, MD, PhD
Weill Medical College of Cornell University
Outcome results
None listed