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Heart-Smile Training Intensive Introduction Program

NCT05564533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-07-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • Korea Advanced Institute of Science and Technology

    collaborator OTHER

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Zev Schuman-Olivier, MD · Cambridge Health Alliance Center for Mindfulness and Compassion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2024-07-01
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564533 on ClinicalTrials.gov