Building Resilience In Caregivers of Trauma Survivors

Caregiver Burnout Clinical Trial

Official title:

Building Resilience In Caregivers of Trauma Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04293016
• Other study ID #: HSC-MS-19-0073
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 26, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 26, 2024
• Est. primary completion date: August 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout

Intervention

Behavioral:
• Support as usual
This group receives current best practice which includes participation in ICU support groups and provision of community support resources
• Problem solving therapy
This group will receive one on one therapy based on identifying stressors and solutions to those stressors
• ICU diary
This group will be provided with a structured written diary that includes identification of stressors and development of solutions to those stressors

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of days of hospitalization	Medical record based review of hospital readmission	6 months post injury
Secondary	Number of infections post discharge	Medical record based review of number of infections after discharge	6 months post injury