Clinical trial NCT05564533: Heart-Smile Training Intensive Introduction Program
Official title: Neurophysiological Effects of Interoceptive Compassion Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Spaulding Rehabilitation Hospital
name: Korea Advanced Institute of Science and Technology
First posted: 2022-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Change from Baseline heartbeat evoked potential (HEP) at 5 weeks
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Change from Baseline Gamma Band Frequency at 5 weeks
timeFrame: Up to 11 weeks
measure: Change from Baseline Depression (CAT-DI) at 5 weeks
timeFrame: Up to 11 weeks
measure: Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 5 weeks.
timeFrame: Up to 11 weeks
Other outcomes:
measure: Change from Baseline Skin Conductance Response at 5 weeks
timeFrame: Up to 11 weeks
measure: Change from Baseline Clinically Relevant Psychological Data at 5 weeks
timeFrame: Up to 11 weeks
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance Center for Mindfulness and Compassion
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance Center for Mindfulness and Compassion
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.
citation: Braboszcz C, Cahn BR, Levy J, Fernandez M, Delorme A. Increased Gamma Brainwave Amplitude Compared to Control in Three Different Meditation Traditions. PLoS One. 2017 Jan 24;12(1):e0170647. doi: 10.1371/journal.pone.0170647. eCollection 2017.
citation: Gibbons RD, Weiss DJ, Pilkonis PA, Frank E, Moore T, Kim JB, Kupfer DJ. Development of a computerized adaptive test for depression. Arch Gen Psychiatry. 2012 Nov;69(11):1104-12. doi: 10.1001/archgenpsychiatry.2012.14.
citation: MacKinnon S, Gevirtz R, McCraty R, Brown M. Utilizing heartbeat evoked potentials to identify cardiac regulation of vagal afferents during emotion and resonant breathing. Appl Psychophysiol Biofeedback. 2013 Dec;38(4):241-55. doi: 10.1007/s10484-013-9226-5.
citation: Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.