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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adults (18-65 years old)

Ability to provide informed consent

English language proficiency

PHQ-9 score > 10, indicating at least moderate depressive symptoms 21

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • heated yoga

    Behavioral

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

  • sauna

    Behavioral

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

  • mindfulness app

    Behavioral

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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: heated yogaExperimental treatment 1 intervention
Group B: saunaExperimental treatment 1 intervention
Group C: mindfulness appActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

The Five Facet Mindfulness Questionnaire (FFMQ-15)

A 15-item self-report instrument that measures mindfulness; derived from factor analytic study of five independent mindfulness questionnaires. Total scores range from 15 to 75, with higher scores indicating greater utilization of mindfulness techniques.

Time frame
Weeks 0, 4, 8, 12, 16, 20
2

Ruminative Responses Scale (RRS)

A 22-item questionnaire that assess rumination, with scores range from 22 to 88. Lower scores reflect less frequent engagement in ruminative thought patterns.

Time frame
Weeks 0, 4, 8, 12, 16, 20
3

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

A 5-item self-report questionnaire with positively-worded statements related to general mood over the prior two weeks. WHO-5 has shown strong construct validity as a measure of general quality of life, and is sensitive to change. Scores range from 0 to 25, with higher scores reflecting overall well-being.

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

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

PROMIS-29 is used to assess psychometric properties under the domains of physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance using four items per domain. This measure uses a T-score metric for scoring, typically ranging from 20 to 80, with a lower T-score (below 50) indicating less severity of symptoms.

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

Other outcomes

1

Acceptability Interview

Used to evaluate participants' thoughts about the study and collect information on their experience. The data collected is qualitative.

Time frame
Week 12

Sponsors and contacts

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