protocolSection identificationModule nctId: NCT06263738, orgStudyIdInfo id: 2024-248, briefTitle: Cold and Heat Investigation to Lower Levels of Depression, acronym: CHILL'D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Vail Health Behavioral Health, class: OTHER, collaborators name: Steadman Philippon Research Institute, descriptionModule briefSummary: This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments., conditionsModule conditions: Depression, conditions: Mood Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Whole Body Hyperthermia, interventions name: Cold Water Plunge, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Warwick Edinburgh Mental Well-Being Scale (WEMWBS), secondaryOutcomes measure: Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety, secondaryOutcomes measure: Sheehan Disability Scale (SDS), secondaryOutcomes measure: Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vail Health Behavioral Health Innovation Center, city: Edwards, state: Colorado, zip: 81632, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 970-445-2489, email: BHIC@vailhealth.org, contacts name: Barry Sandler, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.64499, lon: -106.5942, hasResults: False