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Cold and Heat Investigation to Lower Levels of Depression

NCT06263738 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-11-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Whole Body Hyperthermia

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes

PROCEDURE

Cold Water Plunge

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.

Sponsors & Collaborators

  • Steadman Philippon Research Institute

    collaborator OTHER

  • Barry Sandler

    lead OTHER

Principal Investigators

  • Barry Sandler, DO · Vail Health Behavioral Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263738 on ClinicalTrials.gov