Heart-Smile Training Intensive Introduction Program — HST-IIP  

Depression Clinical Trial

Official title: Neurophysiological Effects of Interoceptive Compassion Training

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression

• NCT number: NCT05564533
• Study type: Interventional
• Source: Cambridge Health Alliance
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2023
• Completion date: September 30, 2024