Cold and Heat Investigation to Lower Levels of Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBarry Sandler
About this trial
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.
Eligibility criteria
Qualifiers
Individuals who currently meet study criteria for depression or individuals who do not currently meet criteria for depression
English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.
Disqualifiers
Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
Use of any medication that may impact thermoregulatory capacity.
Pregnancy, active lactation, or intention to become pregnant during the study period.
Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.
Trial design
Treatments tested in this trial
- Whole Body Hyperthermia
- Cold Water Plunge
Treatment groups
162 Participants
are divided into 4 treatment groupsSponsors and collaborators
Barry Sandler
Lead sponsor
Vail Health Behavioral Health
Sponsor institution
Steadman Philippon Research Institute
Collaborator
Source ClinicalTrials.gov