RECRUITING

Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression

Conditions

Depression Disorders Depression - Major Depressive Disorder Depression Disorder Depression Chronic Depression Depression in Adults heated yoga yoga sauna mindfulness mindfulness app clinical trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms

Official Title

Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression

Quick Facts

Study Start:2025-09-22

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07082998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. adults (18-65 years old) 2. Ability to provide informed consent 3. English language proficiency 4. PHQ-9 score \> 10, indicating at least moderate depressive symptoms 21 5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\* 6. Individuals of childbearing potential must use an acceptable form of birth control 7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study 8. Must be able to the Insight Timer app on a device	1. Pregnant or planning to become pregnant 2. Breast feeding 3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6) 4. Active eating disorders or substance use disorders within the past 12 months, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC) 5. Primary OCD or PTSD, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC) 6. History of bipolar disorder, psychotic disorders, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC) 7. ≥25% drop in PHQ-9 score from screen to baseline 8. Under the influence or withdrawal of drugs or alcohol 9. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the PI or designee) 10. have had a bone fracture or joint surgery in the past 6 months 11. not able to walk freely or without difficulty 12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (the investigator will check in with treating physician in the event that participants endorse any item on the PAR-Q+) 13. participants must have a physician responsible for their medical care 14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes) 15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions) 16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app) 17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer), glomerular filtration rate (GFR) \< 45 ml/min, BP \>160/110. 18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit 19. psychotherapy that has been initiated within the past 3 months 20. psychiatric hospitalization within the past year 21. diagnosed with any neurological disorders that would impact participation or make participation unsafe 22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments 23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios) 24. A subject who, in the opinion of the Principal Investigator, would not be able to safely complete the study or would jeopardize study integrity

Inclusion Criteria

Exclusion Criteria

1. adults (18-65 years old)
2. Ability to provide informed consent
3. English language proficiency
4. PHQ-9 score \> 10, indicating at least moderate depressive symptoms 21
5. Must have filled out the waiver for the community-based partners prior to enrolling in the study\*
6. Individuals of childbearing potential must use an acceptable form of birth control
7. (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
8. Must be able to the Insight Timer app on a device

1. Pregnant or planning to become pregnant
2. Breast feeding
3. Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
4. Active eating disorders or substance use disorders within the past 12 months, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
5. Primary OCD or PTSD, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
6. History of bipolar disorder, psychotic disorders, as per the Composite International Diagnostic Interview Screening Scales (CIDI-SC)
7. ≥25% drop in PHQ-9 score from screen to baseline
8. Under the influence or withdrawal of drugs or alcohol
9. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the PI or designee)
10. have had a bone fracture or joint surgery in the past 6 months
11. not able to walk freely or without difficulty
12. any serious, unstable medical condition as determined by the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (the investigator will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
13. participants must have a physician responsible for their medical care
14. Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)
15. Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)
16. Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)
17. are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent) diuretics, barbiturates, b-blockers, anticholinergics, current ETOH acute intoxication, reduced ability to sweat, hemophilia, pacemaker (magnets used to assemble saunas can interrupt the pacer), glomerular filtration rate (GFR) \< 45 ml/min, BP \>160/110.
18. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
19. psychotherapy that has been initiated within the past 3 months
20. psychiatric hospitalization within the past year
21. diagnosed with any neurological disorders that would impact participation or make participation unsafe
22. are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments
23. are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)
24. A subject who, in the opinion of the Principal Investigator, would not be able to safely complete the study or would jeopardize study integrity

Contacts and Locations

Study Contact

Maren B Nyer, PhD

CONTACT

617-726-8895

mnyer@mgh.harvard.edu

Yian Wu, MPH

CONTACT

617-743-3370

yiwu4@mgh.harvard.edu

Principal Investigator

Maren B Nyer, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Maren B Nyer, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-22

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-09-22

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

depression
heated yoga
yoga
sauna
mindfulness
mindfulness app
clinical trial

Additional Relevant MeSH Terms

Depression Disorders
Depression - Major Depressive Disorder
Depression Disorder
Depression Chronic
Depression
Depression in Adults