Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05564533
Eligibility Criteria:
Inclusion Criteria:
* Sufficient English fluency to understand procedures and questionnaires
* Ability to provide informed consent
* Mild to moderately severe depression (CAT-DI score 35-75) (Achtyes et al., 2015; Gibbons et al., 2012)
Exclusion Criteria:
* Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) \<24 OR the inability to complete consent quiz and baseline assessments (Nasreddine et al., 2005);
* Current participation in another research study;
* Unavailable or unable to participate in planned dates for the HST-IIP sessions;
* Expected hospitalization during the study period, including second and third trimester pregnancy at screening;
* Expected incarceration during the study period;
* Previous experience with mindfulness or other mind-body practices, defined as more than 10 minutes of practice per day, more than 5 days a week for the past 6 months; participation in an 8-week mindfulness group program in the last 2 years; or participation in a meditation retreat longer than 1 day in the past 2 years;
* Inability to successfully complete in-person study sessions with EEG, EKG, respiration rate, and skin conductance response measurement as determined by the principal investigator;
* Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
* Active psychosis defined by a PSY-S-CAT score \> 60 (from the CAT-MH assessment) will trigger the requirement of a clinical assessment prior to participation in the program (Achtyes et al., 2015)
* Bipolar I disorder history or severe level of mania on CAT-MH (score \>70) (Achtyes et al., 2015): In addition, current use of mood stabilizing medication for bipolar disorder.
* Severe depression, indicated by CAT-DI \> 75 (Achtyes et al., 2015; Gibbons et al., 2012)
* Acute homicidality with plan and/or intent;
* Acute suicidality or hospitalization for suicide attempt or self-harm within three months of the enrollment period;
* Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
* Moderate or severe Substance Use Disorder. In addition, reported use of illicit drugs (i.e., cocaine, methamphetamine) OR non-prescribed controlled medications (opioids, stimulants, or benzodiazepines) in the past 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05564533
Study Brief:
Protocol Section:
NCT05564533