Depression, Depression Chronic, Depression Disorder, Depression Disorders, Depression in Adults, Depression - Major Depressive Disorder
Conditions
Keywords
depression, heated yoga, yoga, sauna, mindfulness, mindfulness app, clinical trial
Brief summary
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
Detailed description
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).
Interventions
BEHAVIORALheated yoga
12-weeks of twice weekly 90-min heated yoga classes in the community
BEHAVIORALsauna
12-weeks of twice weekly 40-min sauna sessions in the community
BEHAVIORALmindfulness app
12-weeks of 80-mins a week of a mindfulness app
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subject Characteristics Inclusion 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 access mindfulness app on a device (i.e., smartphone, iPad, etc.) 9. Can travel to Breathe in Harvard Square and at least one Restore location (i.e., Hingham, Somerville, Dedham, Newton, Lynnfield)
Exclusion criteria
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 MINI 5. Primary OCD or PTSD, as per the MINI 6. History of bipolar disorder, psychotic disorders, as per the MINI 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 (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+) 13. 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. 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) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | Weeks 0, 4, 8, 12, 26, 20 | 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
| Measure | Time frame | Description |
|---|---|---|
| The Five Facet Mindfulness Questionnaire (FFMQ-15) | Weeks 0, 4, 8, 12, 16, 20 | 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) | Weeks 0, 4, 8, 12, 16, 20 | 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) | Weeks 0, 4, 8, 12, 16, 20 | 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) | Weeks 0, 4, 8, 12, 16, 20 | 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. |
Countries
United States
Contacts
CONTACTMaren B Nyer, PhD
CONTACTSophie Gower
PRINCIPAL_INVESTIGATORMaren B Nyer, PhD
Massachusetts General Hospital
Outcome results
None listed