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Building Resilience In Caregivers of Trauma Survivors

Primary Purpose

Caregiver Burnout

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Support as usual
problem solving therapy
ICU diary
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caregiver Burnout focused on measuring PTSD, Depression, substance use

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Support as usual

Problem Solving therapy

ICU diary

Arm Description

Outcomes

Primary Outcome Measures

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.
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).
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)

Secondary Outcome Measures

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)
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).
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
Number of days of hospitalization
medical record based review of hospital readmission
Number of infections post discharge
medical record based review of number of infections after discharge

Full Information

First Posted
February 28, 2020
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04293016
Brief Title
Building Resilience In Caregivers of Trauma Survivors
Official Title
Building Resilience In Caregivers of Trauma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
Keywords
PTSD, Depression, substance use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Support as usual
Arm Type
Active Comparator
Arm Title
Problem Solving therapy
Arm Type
Experimental
Arm Title
ICU diary
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Support as usual
Intervention Description
this group receives current best practice which includes participation in ICU support groups and provision of community support resources
Intervention Type
Behavioral
Intervention Name(s)
problem solving therapy
Intervention Description
This group will receive one on one therapy based on identifying stressors and solutions to those stressors
Intervention Type
Behavioral
Intervention Name(s)
ICU diary
Intervention Description
This group will provided with a structured written diary that includes identification of stressors and development of solutions to those stressors
Primary Outcome Measure Information:
Title
short form survey (SF-12)
Description
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.
Time Frame
6 months post injury
Title
Posttraumatic Stress Disorder Checklist(PCL-5)
Description
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).
Time Frame
6 months post injury
Title
The Hamilton Depression Rating Scale (HAM-D)
Description
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)
Time Frame
6 months post injury
Secondary Outcome Measure Information:
Title
The center for epidemiologic studies of depression (CESD-R )
Description
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)
Time Frame
3 months post injury
Title
PTSD Checklist for (PCL-5) assessment.
Description
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).
Time Frame
3 months post injury
Title
The Alcohol Use Disorders identification Test (AUDIT):
Description
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
Time Frame
3 months post injury
Title
Number of days of hospitalization
Description
medical record based review of hospital readmission
Time Frame
6 months post injury
Title
Number of infections post discharge
Description
medical record based review of number of infections after discharge
Time Frame
6 months post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah M Little, PhD
Phone
(713) 486-2524
Email
Deborah.M.Little@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Nguyen, BA
Email
michelle.t.nguyen@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah M Little, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah M Little, PhD
Phone
713-486-2524
Email
Deborah.M.Little@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Michelle Nguyen
Email
michelle.t.nguyen@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Building Resilience In Caregivers of Trauma Survivors

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