Heart-Smile Training Intensive Introduction Program

NCT05564533 | Completed

• 1 other identifier: CHA-IRB-21-22-100
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change from Baseline heartbeat evoked potential (HEP) at 5 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.

  Up to 11 weeks

Secondary Outcomes (3)

• Change from Baseline Gamma Band Frequency at 5 weeks

  Up to 11 weeks

• Change from Baseline Depression (CAT-DI) at 5 weeks

  Up to 11 weeks

• Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 5 weeks.

  Up to 11 weeks

Other Outcomes (2)

• Change from Baseline Skin Conductance Response at 5 weeks

  Up to 11 weeks

• Change from Baseline Clinically Relevant Psychological Data at 5 weeks

  Up to 11 weeks

Study Arms (2)

Heart-Smile Training Intensive Introductory Program (HST-IIP) Group

EXPERIMENTAL

The HST-IIP group will complete the Heart-Smile Training Intensive Introductory Program during weeks 1 through 4 of the study.

Behavioral: Heart-Smile Training Intensive Introduction Program (HST-IIP)

Waitlist Control Group

NO INTERVENTION

The waitlist arm will not complete any intervention during their time in the study. They will continue their treatment as usual without any change in their therapy session or medication. After their post study visits are complete, they will have the opportunity to participate in Mindfulness-Based Intervention courses through the Cambridge Health Alliance Center for Mindfulness and Compassion.

Interventions

Heart-Smile Training Intensive Introduction Program (HST-IIP) BEHAVIORAL

Heart-Smile Training (HST) is an interoceptive compassion program designed to develop the qualities of compassion, empathy, and kindness for oneself and others with a focus on interoceptive awareness. It is unique from other compassion trainings in its focus on 1) embodiment of warmth and tenderness of compassionate feeling with a compassionate body scan meditation, 2) development of an "authentic presence," characterized by a warm feeling of loosened attachment to ego-based self, and 3) cultivation of joy triggered by genuine smile to oneself. HST-IIP is a 3-day/4-week/1-day interoceptive compassion program that shares the same core elements and practices as HST 3-day intensive program. Unlike HST, the format of the HST-IIP has an extended duration to develop self-regulation through the cultivation of emotional and behavioral regulation.

Heart-Smile Training Intensive Introductory Program (HST-IIP) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Spaulding Rehabilitation Hospital: collaborator
• Korea Advanced Institute of Science and Technology: collaborator

Study Sites (1)

Cambridge Health Alliance Center for Mindfulness and Compassion

Somerville, Massachusetts, 02143, United States

Location

Related Publications (6)

• 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.

  PMID: 26030317 BACKGROUND

• 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.

  PMID: 28118405 BACKGROUND

• 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.

  PMID: 23117634 BACKGROUND

• 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.

  PMID: 23824262 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• Kim E, Joss D, Marin F, Anzolin A, Gawande R, Comeau A, Ellis S, Bumpus C, Cahn BR, Kim MWD, Napadow V, Schuman-Olivier Z. Protocol for a Pilot Study on the Neurocardiac Mechanism of an Interoceptive Compassion-Based Heart-Smile Training for Depression. Glob Adv Integr Med Health. 2024 Nov 3;13:27536130241299389. doi: 10.1177/27536130241299389. eCollection 2024 Jan-Dec.

  PMID: 39498312 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance Center for Mindfulness and Compassion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 3, 2022
• Study Start: February 9, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 30, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)