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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coma Family Program 1 | Experimental | This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges. |
|
| Coma Family Program 2 | Placebo Comparator | This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coma Family Program 1 | Behavioral | This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6-weeks, and 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic stress disorder checklist-5 | measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome. | baseline, 6-weeks, and 3-month follow-up |
| World Health Organization Quality of Life-Short Form |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, 6-weeks, and 3-month follow-up |
| Applied Mindfulness Process Scale |
Inclusion Criteria:
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)
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander M Presciutti, PhD | Contact | 617 726 7913 | apresciutti@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
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.
All de-identified data will be preserved for at least seven years after closing the study with IRB.
The de-identified quantitative dataset will be made freely available for requests that are ethically sound.
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| Coma Family Program 2 | Behavioral | This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges. |
|
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. |
| 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). |
| baseline, 6-weeks, and 3-month follow-up |
| 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). | baseline, 6-weeks, and 3-month follow-up |
| 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). | baseline, 6-weeks, and 3-month follow-up |
| Zarit Burden Interview Short Form | Measures caregiver burden. Scores range from 0 (minimum) to 48 (maximum) with higher scores indicating worse outcome (greater caregiver burden). | baseline, 6-weeks, and 3-month follow-up |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
|
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
|
| ID | Term |
|---|---|
| D003128 | Coma |
| D001930 | Brain Injuries |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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