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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
heated yoga
Behavioral12-weeks of twice weekly 90-min heated yoga classes in the community
sauna
Behavioral12-weeks of twice weekly 40-min sauna sessions in the community
mindfulness app
Behavioral12-weeks of 80-mins a week of a mindfulness app
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Acceptability Interview
Used to evaluate participants' thoughts about the study and collect information on their experience. The data collected is qualitative.
Sponsors and contacts
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