Mechanisms of Hyperthermic Yoga for the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
研究概览
简要总结
Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy, and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically healthy adults with mild to moderate depressive symptoms. The primary aim is to test the acceptability and feasibility of hyperthermic yoga as a treatment for depression. The secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive symptoms. The tertiary aim is to explore physiological and psychological mechanisms of action.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-60
- •English language proficiency
- •Ability to provide informed consent
- •Score of >23 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
- •Able and willing to attend two 90-minute hyperthermic yoga sessions per week
- •Willingness to keep existing exercise regimen (even if that is sedentary) stable over study course
- •Women of childbearing potential must use an acceptable form of birth control
- •Membership to the Bikram Yoga Boston and Bikram Yoga Cambridge studios via studio website "Interested in research" option through a centralized portal (this will remain central until January 1, 2017)
- •Willingness to adhere to hydration requirements (i.e., an additional four 8 oz servings of water pre- and post-yoga classes)
排除标准
- •Pregnancy or planned pregnancy during study
- •History of psychiatric hospitalization within the past year
- •Active suicidal intent within the past year ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
- •History of neurologic disorders that could interfere in study participation
- •History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)
- •Psychotropic medication use that has been stable for <3 months
- •Use of stimulant medications or diet pills during the study, or any pre-workout powders or liquids designed to provide excessive energy
- •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 investigator)
- •Active conditions which may also cause depressive symptoms (e.g. epilepsy, hypothyroidism)
- •Medical conditions that may make participation unsafe (e.g., diabetes [I & II], cardiovascular disease, hypertension [>140 systolic and/or >90 diastolic], hypotension [<90 systolic and/or <60 diastolic, during screening], orthostatic hypotension [systolic drop of 20 points or 10 point diastolic or heart rate increase by 10], autoimmune disorders, malignancy, or autonomic dysfunction)
- •> 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or yoga) within the last 6 months
- •Current individual or group psychotherapy established for <3 months
- •A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
- •History of heat intolerance or heat stroke
- •Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's PCP or cardiologist
研究组 & 干预措施
immediate yoga arm
participants will immediately start the 8-week hyperthermic yoga intervention
干预措施: hyperthermic yoga (Behavioral)
delayed yoga arm
participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention
干预措施: hyperthermic yoga (Behavioral)
结局指标
主要结局
Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination
时间窗: at the end of 8-weeks or early termination.
Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be?
Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment
时间窗: 8-week primary end point
Measured by percent of the yoga group who complete a week 8 assessment
Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
时间窗: 8-week primary endpoint
Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)
次要结局
- Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.(8 weeks)
- Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention.(one month post intervention)
- Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.(8 weeks)
- Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks.(8-weeks)
- Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.(8-weeks end point)
- General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)(8 weeks)
- Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks.(8 weeks)
- Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.(8 weeks)
- Long Term Effects of Heated Yoga Intervention -- IDS-CR(one month post intervention)
- Long Term Effects of Heated Yoga Intervention -- PSQI(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- QLESQ(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- SF-36 PF(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- SF-36 GH(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- PSS(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- STAI State(baseline to 1-month follow-up)
- Long Term Effects of Heated Yoga Intervention -- STAI Trait(baseline to 1-month follow-up)
研究者
Maren Nyer
Maren Nyer, PhD
Massachusetts General Hospital