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Heart-Smile Training Intensive Introductory Program (HST-IIP) Group for Depression (HST-IIP Trial)
N/A
Waitlist Available
Led By Zev Schuman-Olivier, MD
Research Sponsored by Cambridge Health Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 weeks
Awards & highlights
HST-IIP Trial Summary
This trial is testing whether Heart-Smile Training, a compassion and loving-kindness-based intensive introduction program, is more effective than a waitlist control group on measures of neural, physiological, and clinically-relevant outcomes among individuals with symptoms of depression.
Who is the study for?
This trial is for individuals with mild to moderately severe depression who speak English well enough to understand the study and can consent. They must be available for all sessions, not in other studies, not expecting hospitalization or incarceration during the study, and without severe mental health conditions that could disrupt participation.Check my eligibility
What is being tested?
The Heart-Smile Training Intensive Introduction Program (HST-IIP) is being tested against a waitlist control group. It includes a 3-day retreat, weekly meetings over four weeks, and a final one-day retreat. The effectiveness will be measured using brain activity tests (EEG), heart monitoring (EKG), skin response tests, and surveys.See study design
What are the potential side effects?
Since HST-IIP involves psychological exercises focused on compassion and loving-kindness rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience emotional discomfort when engaging with their feelings during training.
HST-IIP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 11 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline heartbeat evoked potential (HEP) at 5 weeks
Secondary outcome measures
Change from Baseline Depression (CAT-DI) at 5 weeks
Change from Baseline Gamma Band Frequency at 5 weeks
Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 5 weeks.
Other outcome measures
Change from Baseline Clinically Relevant Psychological Data at 5 weeks
Change from Baseline Skin Conductance Response at 5 weeks
HST-IIP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Heart-Smile Training Intensive Introductory Program (HST-IIP) GroupExperimental Treatment1 Intervention
The HST-IIP group will complete the Heart-Smile Training Intensive Introductory Program during weeks 1 through 4 of the study.
Group II: Waitlist Control GroupActive Control1 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.
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Who is running the clinical trial?
Cambridge Health AllianceLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently expressed a strong desire and plan to harm someone.You have a history of severe bipolar disorder or are currently taking medication for bipolar disorder.You have recently had thoughts of hurting yourself or have been hospitalized for attempting self-harm in the past three months.You have practiced mindfulness or other mind-body techniques for more than 10 minutes a day, at least 5 days a week, for the past 6 months. You have participated in an 8-week mindfulness group program or attended a meditation retreat longer than 1 day within the last 2 years.You have a significant problem with drug use, including using illegal drugs or taking prescription medications without a doctor's prescription, within the past three months.You have a very severe personality disorder that may cause problems within the group.You are able to provide informed consent.You have a level of depression that is not severe but is noticeable (CAT-DI score 35-75).
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control Group
- Group 2: Heart-Smile Training Intensive Introductory Program (HST-IIP) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05564533 — N/A
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