Clinical trial NCT04293016: Building Resilience In Caregivers of Trauma Survivors
Official title: Building Resilience In Caregivers of Trauma Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver Burnout
Keywords: PTSD
Depression
substance use
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine the role of demographics, pre-existing anxiety, depression, and substance use on caregiver depression anxiety, and substance use following a critical injury to a loved one, evaluate the factors that mediate the effectiveness of traditional psychotherapy using problem solving therapy to reduce depression, anxiety, and substance use and to evaluate the factors that mediate the effectiveness of providing an ICU diary and instruction on that diary to reduce depression, anxiety, and substance use.


Eligibility criteria: Inclusion Criteria:

* Must anticipate serving in a Caregiver role after the patient is discharged (A. Must be either a family member or close friend of a patient who has been admitted to the trauma/critical care service ICU B. Must anticipate spending time with the patient in a caregiver or other supportive role (e.g., emotional, social, financial) after the patient is discharged
* Caregiver and patient must report English as a primary language
* Patient and Caregiver must be able to provide informed consent
* Caregiver must be able to provide at least two forms of contact information
* Trauma Patient directly admitted to the ICU (Primary cause of admission is trauma, Injury must include trauma to the head/brain or polytrauma, Admitted directly to the hospital, Patient admission of at least 48 hours, Patient is currently admitted to the ICU, Patient is expected to survive more than 96 hours at 48 hours after admission, Patient has an abbreviated injury score greater than 3 (severe, critical, maximum), Fluent in English)
* Trauma patient must be able to communicate verbally

Exclusion

* Does not anticipate serving in a Caregiver role after the patient is discharged
* Caregiver is not a close friend or family member of the patient who has been admitted to the ICU
* Caregiver does not expect to serve in a supportive role to the patient
* Caregiver does not meet inclusion criteria as stated above
* Patient is not currently admitted to the ICU and or is not expected to remain in the ICU for 48 hours
* Patient is not expected to survive more than 96 hours
* Patient is not expected to require assistance prior to discharge
* Patient is not between 17 and 65 years of age

Primary outcomes:
measure: Short form survey (SF-12)
timeFrame: 6 months post injury
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: 6 months post injury
measure: The Hamilton Depression Rating Scale (HAM-D)
timeFrame: 6 months post injury
Secondary outcomes:
measure: The center for epidemiologic studies of depression (CESD-R )
timeFrame: 3 months post injury
measure: PTSD Checklist for (PCL-5) assessment.
timeFrame: 3 months post injury
measure: The Alcohol Use Disorders identification Test (AUDIT):
timeFrame: 3 months post injury
measure: Number of days of hospitalization
timeFrame: 6 months post injury
measure: Number of infections post discharge
timeFrame: 6 months post injury
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Deborah M Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: