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NCT05564533 · ClinicalTrials.gov registry record · NA
Heart-Smile Training Intensive Introduction Program
A NA study of Depression, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05564533: Completed NA study of Depression, sponsored by Cambridge Health Alliance.
NCT05564533 is a NA study of Depression that has completed, run by Cambridge Health Alliance. The registered enrollment target is 35 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05564533, a NA study of Depression, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Heart-Smile Training Intensive Introduction Program (HST-IIP)
Study Locations (1)
Massachusetts
- Cambridge Health Alliance Center for Mindfulness and Compassion - Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
What the finished NCT05564533 record still lists
NCT05564533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Heart-Smile Training Intensive Introduction Program (HST-IIP) is the first listed.
NCT05564533 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05564533 about?
NCT05564533 is a clinical study titled "Heart-Smile Training Intensive Introduction Program". 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 ...
What is the current status of trial NCT05564533?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2023-02-09. Estimated completion is 2024-09-30.
What conditions does trial NCT05564533 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT05564533?
The interventions under investigation include: Heart-Smile Training Intensive Introduction Program (HST-IIP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05564533?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564533 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05564533's enrollment target sits among peer trials
35 541st of 679 higher than 135 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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