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

NCT07082998 | Recruiting

• 1 other identifier: 2025P001188
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

depression; heated yoga; yoga; sauna; mindfulness; mindfulness app; clinical trial

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  The PHQ- 9 is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. Score range from 0 to 27, with a high score (20-27) indicating severe depression.

  Weeks 0, 4, 8, 12, 26, 20

Secondary Outcomes (4)

• The Five Facet Mindfulness Questionnaire (FFMQ-15)

  Weeks 0, 4, 8, 12, 16, 20

• Ruminative Responses Scale (RRS)

  Weeks 0, 4, 8, 12, 16, 20

• The World Health Organization-5 Well-Being Index (WHO-5)

  Weeks 0, 4, 8, 12, 16, 20

• Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  Weeks 0, 4, 8, 12, 16, 20

Other Outcomes (1)

• Acceptability Interview

  Week 12

Study Arms (3)

heated yoga

EXPERIMENTAL

heated yoga 2x per week for 12 weeks

Behavioral: heated yoga

sauna

EXPERIMENTAL

infrared sauna 2x per week for 12 weeks

Behavioral: sauna

mindfulness app

ACTIVE COMPARATOR

Insight Timer app for 80 mins per week for 12 weeks

Behavioral: mindfulness app

Interventions

heated yoga BEHAVIORAL

12-weeks of twice weekly 90-min heated yoga classes in the community

heated yoga

sauna BEHAVIORAL

12-weeks of twice weekly 40-min sauna sessions in the community

sauna

mindfulness app BEHAVIORAL

12-weeks of 80-mins a week of a mindfulness app

mindfulness app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (18-65 years old)
• Ability to provide informed consent
• English language proficiency
• PHQ-9 score \> 10, indicating at least moderate depressive symptoms 21
• Must have filled out the waiver for the community-based partners prior to enrolling in the study\*
• Individuals of childbearing potential must use an acceptable form of birth control
• (if applicable) willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
• Must be able to access mindfulness app on a device (i.e., smartphone, iPad, etc.)
• Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)

You may not qualify if:

• Pregnant or planning to become pregnant
• Breast feeding
• Active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
• Active eating disorders or substance use disorders within the past 12 months, as per the MINI
• Primary OCD or PTSD, as per the MINI
• History of bipolar disorder, psychotic disorders, as per the MINI
• ≥25% drop in PHQ-9 score from screen to baseline
• Under the influence or withdrawal of drugs or alcohol
• have had a bone fracture or joint surgery in the past 6 months
• not able to walk freely or without difficulty
• 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 (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
• participants must have a healthcare provider who they could contact if they needed medical care, such as a primary care doctor, a counselor, a psychiatrist, a nurse practitioner, or a clinic that you go to.
• Significant exposure to heated yoga classes in the past 3 months (i.e., more than 6 classes)
• Significant exposure to sauna sessions in the past 3 months (i.e., more than 6 sessions)
• Significant exposure to mindfulness app in the past 3 months (i.e., more than 6 uses of the app)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Steam Bath

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics; Hyperthermia, Induced

Study Officials

• Maren B Nyer, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maren B Nyer, PhD

CONTACT

617-726-8895; mnyer@mgh.harvard.edu

Yian Wu, MPH

CONTACT

617-743-3370; yiwu4@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical psychologist

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)