Building Resilience In Caregivers of Trauma Survivors

NCT04293016 | Active Not Recruiting

• 1 other identifier: HSC-MS-19-0073
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burnout

Keywords

PTSD; Depression; substance use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• The center for epidemiologic studies of depression (CESD-R )

  3 months post injury

• PTSD Checklist for (PCL-5) assessment.

  3 months post injury

• The Alcohol Use Disorders identification Test (AUDIT):

  3 months post injury

• Number of days of hospitalization

  6 months post injury

• Number of infections post discharge

  6 months post injury

Study Arms (3)

Support as usual

ACTIVE COMPARATOR

Behavioral: Support as usual

Problem Solving therapy

EXPERIMENTAL

Behavioral: Problem solving therapy

ICU diary

EXPERIMENTAL

Behavioral: ICU diary

Interventions

Support as usual BEHAVIORAL

This group receives current best practice which includes participation in ICU support groups and provision of community support resources

Support as usual

Problem solving therapy BEHAVIORAL

This group will receive one on one therapy based on identifying stressors and solutions to those stressors

Problem Solving therapy

ICU diary BEHAVIORAL

This group will be provided with a structured written diary that includes identification of stressors and development of solutions to those stressors

ICU diary

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• United States Department of Defense: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Stress Disorders, Post-Traumatic; Depression; Substance-Related Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Deborah M Little, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: March 1, 2022
• Primary Completion: August 18, 2024
• Study Completion: August 26, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)