Clinical trial NCT06263738: Cold and Heat Investigation to Lower Levels of Depression
Official title: Cold and Heat Investigation to Lower Levels of Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Mood Disorders
Keywords: Depression
Mood Disorders
Mental Health
Integrative Health
Hyperthermia
Sauna
Cold Plunge
Lead sponsor: Vail Health Behavioral Health
Sponsor class: OTHER
Collaborators: name: Steadman Philippon Research Institute
First posted: 2024-02-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold).
Primary purpose: TREATMENT

Brief 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.

Detailed description: The CHILL'D Study aims to figure out how using heat exposure as a treatment for major depressive disorder (MDD) can work better. The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone.

The researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone.

To answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes. 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 lasting up to 10 minutes.

Eligibility criteria: Inclusion Criteria:

* Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening
* 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.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Secondary outcomes:
measure: Warwick Edinburgh Mental Well-Being Scale (WEMWBS)
timeFrame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
measure: Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety
timeFrame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
measure: Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF)
timeFrame: Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Other outcomes:
Locations:
city: Edwards
country: United States
facility: Vail Health Behavioral Health Innovation Center
state: Colorado
Study officials:
affiliation: Vail Health Behavioral Health
name: Barry Sandler, DO
role: PRINCIPAL_INVESTIGATOR
References: