Cold and Heat Investigation to Lower Levels of Depression
Recruiting · NCT06263738 · Interventional (participants receive a specific treatment) · Lead sponsor: Barry Sandler
View the official record on ClinicalTrials.gov →Interventions studied
Cold Water PlungeWhole Body Hyperthermia
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Vail Health Behavioral Health Innovation Center - Edwards, Colorado, United States