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COMPLETED NA

Heart-Smile Training Intensive Introduction Program

NCT05564533 · View on ClinicalTrials.gov ↗

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 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

FieldValue
Enrollment Target 35 participants
Start Date 2023-02-09
Est. Completion 2024-09-30
Phase NA

Sponsor

Cambridge Health Alliance

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05564533

The ClinicalTrials.gov registry entry for NCT05564533 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cambridge Health Alliance, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05564533 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05564533?

The interventions under investigation include: Heart-Smile Training Intensive Introduction Program (HST-IIP) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05564533?

This trial is sponsored by Cambridge Health Alliance, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial