Cold and Heat Investigation to Lower Levels of Depression

Part of paid clinical trials in Edwards, Colorado.

Sponsor
Barry Sandler
Study ID
NCT06263738
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Whole Body Hyperthermia — PROCEDURE
    Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes
  • Cold Water Plunge — PROCEDURE
    Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session in 55 degree (Fahrenheit) water, lasting up to 10 minutes.

Study Details

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.

Key Dates

Start date
May 14, 2024
Status verified
Nov 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Depression + Whole Body Hyperthermia
    Participants experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.
  • Active Comparator: Depression + Whole Body Hyperthermia + Cold Water Plunge
    Participants experiencing depression will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.
  • Active Comparator: No Depression + Whole Body Hyperthermia
    Participants not experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.
  • Active Comparator: No Depression + Whole Body Hyperthermia + Cold Water Plunge
    Participants not experiencing depression will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vail Health Behavioral Health Innovation CenterEdwardsColorado81632
Study Coordinator
[email protected]
970-445-2489
Barry Sandler, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Edwards, CO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Vail Health Behavioral Health Innovation Center· Edwards, CO

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