Heat and cold therapy for reducing depression symptoms
Cold and Heat Investigation to Lower Levels of Depression
NA · Vail Health Behavioral Health · NCT06263738
This study is testing whether a combination of heat therapy and a cold water plunge can help reduce depression symptoms in adults with major depressive disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vail Health Behavioral Health (other) |
| Locations | 1 site (Edwards, Colorado) |
| Trial ID | NCT06263738 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of heat exposure followed by a cold water plunge on depressive symptoms in adults. A total of 112 medically healthy participants aged 18-65 with major depressive disorder will be randomized into two groups: one receiving only heat therapy and the other receiving heat therapy followed by a cold plunge. Participants will undergo assessments of their depressive symptoms before treatment and at one and two weeks post-treatment to evaluate the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have been experiencing depressive symptoms for at least 60 days.
Not a fit: Patients with a history of adverse reactions to temperature changes or those with active suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option for individuals suffering from depression.
How similar studies have performed: While the combination of heat and cold therapy is less commonly studied, similar approaches using heat exposure have shown promise in improving mood disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Edwards, Colorado
- Vail Health Behavioral Health Innovation Center — Edwards, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Barry Sandler, DO — Vail Health Behavioral Health
- Study coordinator: Study Coordinator
- Email: BHIC@vailhealth.org
- Phone: 970-855-7374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Mood Disorders, Healthy, Mental Health, Integrative Health, Hyperthermia, Sauna, Cold Plunge