Building Resilience In Caregivers of Trauma Survivors

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Caregiver Burnout

Treatments: Behavioral: Support as usual; Behavioral: Problem solving therapy; Behavioral: ICU diary

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04293016

HSC-MS-19-0073

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Support as usual

Active Comparator group

Treatment:

Behavioral: Support as usual

Problem Solving therapy

Experimental group

Treatment:

Behavioral: Problem solving therapy

ICU diary

Experimental group

Treatment:

Behavioral: ICU diary