RECRUITING

Cold and Heat Investigation to Lower Levels of Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cold and Heat Investigation to Lower Levels of Depression

Quick Facts

Study Start:2024-05-14
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06263738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration.
  2. * Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening
  3. * English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
  4. * Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.
  1. * Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
  2. * Use of any medication that may impact thermoregulatory capacity.
  3. * Pregnancy, active lactation, or intention to become pregnant during the study period.
  4. * Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
970-855-7374
BHIC@vailhealth.org

Principal Investigator

Barry Sandler, DO
PRINCIPAL_INVESTIGATOR
Vail Health Behavioral Health

Study Locations (Sites)

Vail Health Behavioral Health Innovation Center
Edwards, Colorado, 81632
United States

Collaborators and Investigators

Sponsor: Vail Health Behavioral Health

  • Barry Sandler, DO, PRINCIPAL_INVESTIGATOR, Vail Health Behavioral Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Mood Disorders
  • Mental Health
  • Integrative Health
  • Hyperthermia
  • Sauna
  • Cold Plunge

Additional Relevant MeSH Terms

  • Depression
  • Mood Disorders