This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
This is a parallel group study design. The investigators plan to enroll 120 adults who have at least moderate depression and will be randomized in an equal allocation ratio (i.e., 1:1:1) across three groups: heated yoga vs. sauna vs. a mindfulness app. The interventions will be provided over a 12-week period and assessments will occur at baseline (Week 0), mid-intervention (Weeks 4 \& 8), post-intervention (Week 12, primary outcome), and at a 4-week (Week 16). Then participants enter an optional 1-month choice intervention period with a post-assessment (Week 20).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
12-weeks of twice weekly 90-min heated yoga classes in the community
12-weeks of twice weekly 40-min sauna sessions in the community
12-weeks of 80-mins a week of a mindfulness app
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGPatient 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
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
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
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
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
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