Cold and Heat Investigation to Lower Levels of Depression

Depression Clinical Trial

— CHILL'D  

Official title:

Cold and Heat Investigation to Lower Levels of Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263738
• Other study ID #: 2024-248
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Vail Health Behavioral Health
• Contact: Study Coordinator
• Phone: 970-855-7374
• Email: BHIC[@]vailhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Mood Disorders

Intervention

Procedure:
• Whole Body Hyperthermia
Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes
• Cold Water Plunge
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 49 degree (Fahrenheit) water, lasting up to 10 minutes.

Locations

Country	Name	City	State
United States	Vail Health Behavioral Health Innovation Center	Edwards	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Vail Health Behavioral Health	Steadman Philippon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Warwick Edinburgh Mental Well-Being Scale (WEMWBS)	The WEMWBS was designed to measure the psychological well-being of a population and has been shown to be responsive to novel interventions such as psychedelics. WEMWBS has 14 questions scored using a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". Scores reflect feelings and thoughts in the two weeks prior to answering the questionnaire. The WEMWBS assesses both emotional and functional aspects of mental well-being. Total scores range from 14 to 70, with higher scores correlating to higher levels of well-being.	Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Secondary	Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety	The PROMIS Anxiety measure focuses on fear (e.g., worry, feelings of panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness) and has been found to be a clinically validated measure of anxiety. The PROMIS 8A--Anxiety is comprised of eight items, each rated on a scale from 1 ("Never") to 5 ("Always"). Total scores range from 8 to 40, with higher scores correlating to higher levels of anxiety.	Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Secondary	Sheehan Disability Scale (SDS)	The SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the patient's life are impaired by psychiatric symptoms, including depression. This scale has been used widely in psychopharmacology randomized, controlled trials and has been accepted by the Food and Drug Administration (FDA) for functional disability labeling. The SDS uses visual-spatial, numeric, and verbal descriptive anchors simultaneously to assess disability across 3 domains: work, social life, and family life. The SDS asks participants to rate the extent to which their 1) work/school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analogue scale. Total scores range from 0 to 30, with higher scores correlating to higher levels of disability.	Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)
Secondary	Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF)	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form version contains 16 items assessing changes in quality of life, divided into the following sections: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. A total score is derived from summing the first 14 items on the scale, with the last 2 items serving as stand-alone queries. Total score ranges from 14 to 70, with higher scores correlating with higher levels of quality of life.	Baseline/Treatment (Visit 1), 1 Week Post-Treatment (Visit 2), 2 Weeks Post-Treatment (Visit 3)