Cold and Heat Investigation to Lower Levels of Depression

NCT06263738 | Recruiting

• 1 other identifier: 20244106
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Mood Disorders; Healthy (Controls)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  The MADRS is a validated 10-item questionnaire to assess depression severity and is commonly used to assess efficacy of an intervention in clinical trials. Each item of the MADRS is measured on a scale of 0 to 6 (for a total score of 0 to 60) with higher scores indicating more severe depression. The MADRS includes questions on the following symptoms: 1. Reported sadness; 2. Apparent sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; 10. Suicidal thoughts. Items are scored via a clinical interview that progresses from more broadly phrased questions about symptoms to more detailed queries that allow a precise rating of severity.

  Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

Secondary Outcomes (4)

• Warwick Edinburgh Mental Well-Being Scale (WEMWBS)

  Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

• Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety

  Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

• Sheehan Disability Scale (SDS)

  Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

• Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF)

  Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)

Study Arms (4)

Depression + Whole Body Hyperthermia

ACTIVE COMPARATOR

Participants experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.

Procedure: Whole Body Hyperthermia

Depression + Whole Body Hyperthermia + Cold Water Plunge

ACTIVE COMPARATOR

Participants experiencing depression 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.

Procedure: Whole Body Hyperthermia; Procedure: Cold Water Plunge

No Depression + Whole Body Hyperthermia

ACTIVE COMPARATOR

Participants not experiencing depression will receive a single heat treatment using the Clearlight Sauna Dome lasting up to 140 minutes.

Procedure: Whole Body Hyperthermia

No Depression + Whole Body Hyperthermia + Cold Water Plunge

ACTIVE COMPARATOR

Participants not experiencing depression 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.

Procedure: Whole Body Hyperthermia; Procedure: Cold Water Plunge

Interventions

Whole Body Hyperthermia PROCEDURE

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

Also known as: Infrared Sauna, Whole Body Heating

Depression + Whole Body Hyperthermia; Depression + Whole Body Hyperthermia + Cold Water Plunge; No Depression + Whole Body Hyperthermia; No Depression + Whole Body Hyperthermia + Cold Water Plunge

Cold Water Plunge PROCEDURE

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 in 55 degree (Fahrenheit) water, lasting up to 10 minutes.

Also known as: Cold Plunge, Cold Water Exposure

Depression + Whole Body Hyperthermia + Cold Water Plunge; No Depression + Whole Body Hyperthermia + Cold Water Plunge

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barry Sandler: lead
• Steadman Philippon Research Institute: collaborator

Study Sites (1)

Vail Health Behavioral Health Innovation Center

Edwards, Colorado, 81632, United States

RECRUITING

MeSH Terms

Conditions

Depression; Mood Disorders; Psychological Well-Being; Hyperthermia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Barry Sandler, DO

  Vail Health Behavioral Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

970-855-7374; BHIC@vailhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Vail Healthspan

Model Details: 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).

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Following publication of primary study findings.
• Access Criteria: De-identified data will be made available to qualified researchers in a way that protects subject confidentiality and adheres to HIPAA policies. Both internal and external requests for data will be handled by the study team to ensure equitable access, fairness, and safeguards. After reviewing a short proposal prepared by an external investigator, the study team will approve requests with appropriate experimental design, scientific merit, and Institutional Review Board (IRB) approval and recommend revisions for proposals requiring further justification or modifications. Informed consent documents will provide sufficient detail about the intent to archive, share, and re-analyze data.

Locations

US (1)