Neurophysiological Effects of Interoceptive Compassion Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from Baseline heartbeat evoked potential (HEP) at 5 weeks
研究概览
简要总结
Heart-Smile Training (HST) is a compassion and loving-kindness-based intensive introduction program consisting of a 3-day retreat, 4-weeks of weekly 2 hour meetings, and a 1-day final retreat. This study is a randomized controlled trial study to evaluate the effectiveness of Heart-Smile Training as compared to the passive control group on measures of neural, physiological, and clinically-relevant outcomes among individuals with symptoms of depression. Participants will be randomized to either the HST group or a waitlist control group. Both groups will complete assessments before and after HST including electroencephalography (EEG), electrocardiogram (EKG), electrodermal activity tests, and self-report surveys. All study activities except surveys will be conducted in person.
详细描述
This will be a randomized controlled trial with two arms: Heart-Smile Training Intensive Introduction Program (HST-IIP) vs. a waitlist control group. These two arms will be compared on measures of neural, physiological, and clinically-relevant outcomes.
The investigators will enroll up to 50 adult volunteers from the general population from the ages of 18 to 65 with depression, with Computerized Adaptive Test- Depression Inventory (CAT-DI) scores from 35-75. Volunteers interested in the study will be consented and screened for their eligibility. Eligible participants will be randomized to join either the HST-IIP arm or a waitlist control arm after completing all baseline assessments and the EEG session.
Both the HST-IIP and waitlist arm will complete a baseline measurement session between study weeks -3 to 0, before starting any group sessions. Prior to completing the baseline measurement section, they will be randomized to either HST-IIP or the waitlist arm. Participants enrolled in the HST-IIP arm will join the intervention group between week 1 to 5. The waitlist arm will not join any program between week 1 to 5. They will continue their treatment as usual without any change in their therapy session or medication. Both arms will complete weekly survey measures for 5 weeks. Both arms will then complete a post measurement session during study weeks 5 to 7.
At both baseline and post-intervention measurement sessions, all participants will complete in-person study tasks and remote surveys. In-person study visits will include neurophysiological measures; EEG, EKG, skin conductance, and respiration rate measures and will take place at the Spaulding Rehabilitation Hospital/Mass General Brigham in Charlestown, MA. Remote self-report surveys will be completed by participants during baseline and post-measurement either at home through a link secure to the Cambridge Health Alliance (CHA) REDCap database sent via email or using an electronic device at the CHA Center for Mindfulness and Compassion.
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
- Double (Investigator, 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
- •Sufficient English fluency to understand procedures and questionnaires
- •Ability to provide informed consent
- •Mild to moderately severe depression (CAT-DI score 35-75) (Achtyes et al., 2015; Gibbons et al., 2012)
排除标准
- •Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments (Nasreddine et al., 2005);
- •Current participation in another research study;
- •Unavailable or unable to participate in planned dates for the HST-IIP sessions;
- •Expected hospitalization during the study period, including second and third trimester pregnancy at screening;
- •Expected incarceration during the study period;
- •Previous experience with mindfulness or other mind-body practices, defined as more than 10 minutes of practice per day, more than 5 days a week for the past 6 months; participation in an 8-week mindfulness group program in the last 2 years; or participation in a meditation retreat longer than 1 day in the past 2 years;
- •Inability to successfully complete in-person study sessions with EEG, EKG, respiration rate, and skin conductance response measurement as determined by the principal investigator;
- •Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
- •Active psychosis defined by a PSY-S-CAT score > 60 (from the CAT-MH assessment) will trigger the requirement of a clinical assessment prior to participation in the program (Achtyes et al., 2015)
- •Bipolar I disorder history or severe level of mania on CAT-MH (score >70) (Achtyes et al., 2015): In addition, current use of mood stabilizing medication for bipolar disorder.
- •Severe depression, indicated by CAT-DI > 75 (Achtyes et al., 2015; Gibbons et al., 2012)
- •Acute homicidality with plan and/or intent;
- •Acute suicidality or hospitalization for suicide attempt or self-harm within three months of the enrollment period;
- •Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
- •Moderate or severe Substance Use Disorder. In addition, reported use of illicit drugs (i.e., cocaine, methamphetamine) OR non-prescribed controlled medications (opioids, stimulants, or benzodiazepines) in the past 3 months.
结局指标
主要结局
Change from Baseline heartbeat evoked potential (HEP) at 5 weeks
时间窗: Up to 11 weeks
HEP has been used as a marker to assess interoceptive awareness between depressed individuals and normal control (MacKinnon et al., 2013). The second primary outcome is to evaluate the effects of HST-IIP on EEG heartbeat evoked potentials (HEP) and the correlation between the pre- versus post-intervention changes in HEP amplitude and changes in depression severity.
次要结局
- Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 5 weeks.(Up to 11 weeks)
- Change from Baseline Depression (CAT-DI) at 5 weeks(Up to 11 weeks)
- Change from Baseline Gamma Band Frequency at 5 weeks(Up to 11 weeks)