About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older - study population
English fluency and literacy - measures and intervention are in English
Screens positive for emotional distress on either depression or anxiety subscales (>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)
18 years or older - study population
Disqualifiers
1. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
Trial design
Parallel
Treatments tested in this trial
Coma Family Program 1
BehavioralThis intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Coma Family Program 2
BehavioralThis involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Posttraumatic stress disorder checklist-5
measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.
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.
Other outcomes
Cognitive and Affective Mindfulness Scale
measures dispositional mindfulness. Scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better outcome (greater dispositional mindfulness).
Applied Mindfulness Process Scale
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).
Measure of Current Status-A
measures adaptive coping. Scores range from 0 (minimum) to 4 (maximum) with higher scores indicating better outcome (better use of adaptive coping skills).
Intolerance of Uncertainty Scale Short Form
Measures intolerance of uncertainty. Scores range from 12 (minimum) to 60 (maximum) with higher scores indicating worse outcome (greater intolerance of uncertainty).
Sponsors and contacts
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