Brain Injury, Caregiver Distress, Caregivers, Coma, Emotional Distress, Resilience
Conditions
Keywords
caregivers, emotional distress, caregiver burden, resilience, coma, severe acute brain injury, mindfulness
Brief summary
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.
Interventions
BEHAVIORALComa Family Program 1
This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
BEHAVIORALComa Family Program 2
This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older - study population 2. English fluency and literacy - measures and intervention are in English 3. 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) 4. 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: 1. 18 years or older - study population 2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population 3. Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population 4. Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention) 5. Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and/or percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive/functional recovery from initial coma, but all were severe enough to require trach and/or PEG 6. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in "d"; such caregivers would require different intervention 7. Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \<7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)
Exclusion criteria
* 1\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital anxiety and depression scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic stress disorder checklist-5 | 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. |
| World Health Organization Quality of Life-Short Form | 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. |
Countries
United States
Contacts
CONTACTAlexander M Presciutti, PhD
Outcome results
None listed