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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 between 18 and 65 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.
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 4 weeks
Secondary outcome measures
Cat Diseases
Oligoclonal Bands (protein)
Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 4 weeks.
Other outcome measures
Change from Baseline Clinically Relevant Psychological Data at 4 weeks
Skin
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical study accept participants above the age of forty-five?
"This clinical trial requires participants to be within the age range of 18 and 60. There are 177 studies available for individuals below this threshold, while 850 have been established for those above it."
Answered by AI
Is the enrollment process for this clinical trial still open?
"Based on the information posted to clinicaltrials.gov, it appears that this trial is no longer actively seeking participants; however, 1136 other trials are still in need of enrollees. This specific study was initially published on November 1st 2022 and last updated almost a month ago on September 29th 2022."
Answered by AI
What kind of criteria must a participant satisfy to be enrolled in this experiment?
"A cohort of 50 people aged 18-60 suffering from depression can volunteer for this trial. Requirements are fluency in English to comprehend the procedures and questions, the capacity to grant informed consent, and a moderate-to-severe CAT-DI score between 35 and 75 (as determined by Achtyes et al., 2015; Gibbons et al., 2012)."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Cambridge Health Alliance Center for Mindfulness and Compassion
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
2
Why did patients apply to this trial?
Relief from depression, MCI and stress.
PatientReceived 1 prior treatment
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