An interventional study of Coma Family Program 1 and Coma Family Program 2 in Caregiver Distress, Emotional Distress and Caregivers, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.
138 studies on the registry are indexed under Coma; 35 are open to participants now.
This study's planned enrollment of 150 is above the median of 85 across 77 interventional studies indexed under Coma.
Browse Coma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:
Exclusion Criteria:
This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Behavioral: Coma Family Program 1
This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.
Behavioral: Coma Family Program 2
This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.
Hospital anxiety and depression scale
Measures anxiety and depression. Anxiety and depression sub scales each range from 0 (minimum) to 21 (maximum) with higher scores meaning worse outcome.
Time frame: baseline, 6-weeks, and 3-month follow-up
Posttraumatic stress disorder checklist-5
measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.
Time frame: baseline, 6-weeks, and 3-month follow-up
World Health Organization Quality of Life-Short Form
Measures quality of life across four domains, physical, psychological, social, and environmental. Scores on each sub scale range from 0 (minimum) to 100 (maximum) with higher scores indicating better outcome.
Time frame: baseline, 6-weeks, and 3-month follow-up
Not enrolling at this site.
Plan to share: Yes — Data includes caregiver demographic characteristics, health characteristics (quality of life), and outcome assessments (e.g., emotional distress, coping, mindfulness, etc). These measures will be self-reported. We will also collect limited quantitative data extracted from patients' medical charts (diagnosis, age, race, ethnicity). All data will be de-identified and preserved for at least seven years after closing the study with IRB. Quantitative datasets will be made available via the Vivli database.
Supporting information: Study protocol, Informed consent form
Time frame: All de-identified data will be preserved for at least seven years after closing the study with IRB.
Access criteria: The de-identified quantitative dataset will be made freely available for requests that are ethically sound.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Icahn School of Medicine at Mount Sinai →