heart-smile training intensive introduction program

Conditions: Depression

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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) exclusion criteria: * 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.