Coma Family Program 1
BehavioralThis intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
NCT Number: NCT07331324
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
University of Maryland School of Medicine, Baltimore, Maryland, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline, 6-weeks, and 3-month follow-up
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
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
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
measures dispositional mindfulness. Scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better outcome (greater dispositional mindfulness).
Time frame: baseline, 6-weeks, and 3-month follow-up
measures applied mindfulness. Scores range from 0 (minimum) to 60 (maximum) with higher scores indicating better outcome (more frequent application of mindfulness skills in daily life).
Time frame: baseline, 6-weeks, and 3-month follow-up
measures adaptive coping. Scores range from 0 (minimum) to 4 (maximum) with higher scores indicating better outcome (better use of adaptive coping skills).
Time frame: baseline, 6-weeks, and 3-month follow-up
Measures intolerance of uncertainty. Scores range from 12 (minimum) to 60 (maximum) with higher scores indicating worse outcome (greater intolerance of uncertainty).
Time frame: baseline, 6-weeks, and 3-month follow-up
Measures caregiver burden. Scores range from 0 (minimum) to 48 (maximum) with higher scores indicating worse outcome (greater caregiver burden).
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Acronym: COMA-F
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