Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject Characteristics
- •Inclusion Criteria:
- •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)
排除标准
- •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
- •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)
- •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)
- •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)
- •antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
- •psychotherapy that has been initiated within the past 3 months
- •psychiatric hospitalization within the past year
- •diagnosed with any neurological disorders that would impact participation or make participation unsafe
- •are currently in active ketamine, Electroconvulsive therapy, or Transcranial Magnetic Stimulation treatments
- •are unable to follow the study procedures (e.g., not able to travel to the heated yoga or sauna studios)
- •A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
研究组 & 干预措施
heated yoga
heated yoga 2x per week for 12 weeks
干预措施: heated yoga (Behavioral)
sauna
infrared sauna 2x per week for 12 weeks
干预措施: sauna (Behavioral)
mindfulness app
Insight Timer app for 80 mins per week for 12 weeks
干预措施: mindfulness app (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 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.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Weeks 0, 4, 8, 12, 16, 20)
- 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)
研究者
Maren Nyer
clinical psychologist
Massachusetts General Hospital