Building Resilience In Caregivers of Trauma Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burnout
• Intervention / Treatment: Behavioral: Support as usual; Behavioral: problem solving therapy; Behavioral: ICU diary

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah M Little, PhD; Phone Number: (713) 486-2524; Email: Deborah.M.Little@uth.tmc.edu
• Study Contact Backup: Name: Michelle Nguyen, BA; Email: michelle.t.nguyen@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Deborah M Little, PhD; Phone Number: 713-486-2524; Email: Deborah.M.Little@uth.tmc.edu
      • Contact: Michelle Nguyen; Email: michelle.t.nguyen@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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, 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 t 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 18 and 65 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Support as usual	Behavioral: Support as usual; this group receives current best practice which includes participation in ICU support groups and provision of community support resources
Experimental: Problem Solving therapy	Behavioral: problem solving therapy; This group will receive one on one therapy based on identifying stressors and solutions to those stressors
Experimental: ICU diary	Behavioral: ICU diary; This group will provided with a structured written diary that includes identification of stressors and development of solutions to those stressors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short form survey (SF-12)	Quality of life of caregiver as assessed by the short form survey (SF-12).The SF-12 is a 12 item questionnaire with a range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	6 months post injury
Posttraumatic Stress Disorder Checklist(PCL-5)	The extent to which caregivers have been bothered by PTSD symptoms as assessed by the PTSD Checklist (PCL-5) assessment.The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).	6 months post injury
The Hamilton Depression Rating Scale (HAM-D)	Symptoms of depression in caregivers as assessed by the The Hamilton Depression Rating Scale (HAM-D).Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0(Absent)-2(frequent)	6 months post injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The center for epidemiologic studies of depression (CESD-R )	Depression in caregivers as assessed by the CESD-R tool The CESD-R scale has 20 items and each is measured from 0(not at all) to 4(nearly every day for 2 weeks)	3 months post injury
PTSD Checklist for (PCL-5) assessment.	The extent to which caregivers have been bothered by PTSD symptoms as assessed by the PTSD Checklist (PCL-5) assessment.The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).	3 months post injury
The Alcohol Use Disorders identification Test (AUDIT):	Alcohol use problems in caregivers as assessed by the AUDIT scale This is a 10-item screening tool and is rated between 0-4-the higher number indicating a worse outcome	3 months post injury
Number of days of hospitalization	medical record based review of hospital readmission	6 months post injury
Number of infections post discharge	medical record based review of number of infections after discharge	6 months post injury

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Deborah M Little, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): August 28, 2024
• Study Completion (Anticipated): August 28, 2024

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; Depression; substance use
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: HSC-MS-19-0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No