MedPath

Heart-Smile Training Intensive Introduction Program

Not Applicable
Active, not recruiting
Conditions
Depression
Registration Number
NCT05564533
Lead Sponsor
Cambridge Health Alliance
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
35
Inclusion Criteria

Inclusion Criteria:<br><br> - Sufficient English fluency to understand procedures and questionnaires<br><br> - Ability to provide informed consent<br><br> - Mild to moderately severe depression (CAT-DI score 35-75) (Achtyes et al., 2015;<br> Gibbons et al., 2012)<br><br>Exclusion Criteria:<br><br> - Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR<br> the inability to complete consent quiz and baseline assessments (Nasreddine et al.,<br> 2005);<br><br> - Current participation in another research study;<br><br> - Unavailable or unable to participate in planned dates for the HST-IIP sessions;<br><br> - Expected hospitalization during the study period, including second and third<br> trimester pregnancy at screening;<br><br> - Expected incarceration during the study period;<br><br> - Previous experience with mindfulness or other mind-body practices, defined as more<br> than 10 minutes of practice per day, more than 5 days a week for the past 6 months;<br> participation in an 8-week mindfulness group program in the last 2 years; or<br> participation in a meditation retreat longer than 1 day in the past 2 years;<br><br> - Inability to successfully complete in-person study sessions with EEG, EKG,<br> respiration rate, and skin conductance response measurement as determined by the<br> principal investigator;<br><br> - Inability to participate safely in the study intervention and without disrupting the<br> group (in the opinion of principal investigator OR meeting any of the following<br> criteria):<br><br> - Active psychosis defined by a PSY-S-CAT score > 60 (from the CAT-MH assessment) will<br> trigger the requirement of a clinical assessment prior to participation in the<br> program (Achtyes et al., 2015)<br><br> - Bipolar I disorder history or severe level of mania on CAT-MH (score >70) (Achtyes<br> et al., 2015): In addition, current use of mood stabilizing medication for bipolar<br> disorder.<br><br> - Severe depression, indicated by CAT-DI > 75 (Achtyes et al., 2015; Gibbons et al.,<br> 2012)<br><br> - Acute homicidality with plan and/or intent;<br><br> - Acute suicidality or hospitalization for suicide attempt or self-harm within three<br> months of the enrollment period;<br><br> - Severe Borderline Personality Disorder or other severe personality disorder that may<br> lead to disruptions within the group; and/or<br><br> - Moderate or severe Substance Use Disorder. In addition, reported use of illicit<br> drugs (i.e., cocaine, methamphetamine) OR non-prescribed controlled medications<br> (opioids, stimulants, or benzodiazepines) in the past 3 months.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change from Baseline heartbeat evoked potential (HEP) at 5 weeks
Secondary Outcome Measures
NameTimeMethod
Change from Baseline Gamma Band Frequency at 5 weeks;Change from Baseline Depression (CAT-DI) at 5 weeks;Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 5 weeks.
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