Building Resilience In Caregivers of Trauma Survivors

NCT ID: NCT04293016

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-08-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Support as usual

Group Type: ACTIVE_COMPARATOR

Support as usual

Intervention Type: BEHAVIORAL

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

Problem Solving therapy

Group Type: EXPERIMENTAL

Problem solving therapy

Intervention Type: BEHAVIORAL

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

ICU diary

Group Type: EXPERIMENTAL

ICU diary

Intervention Type: BEHAVIORAL

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

Interventions

Support as usual

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

Intervention Type: BEHAVIORAL

Problem solving therapy

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

Intervention Type: BEHAVIORAL

ICU diary

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

Intervention Type: BEHAVIORAL

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 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Deborah M Little

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah M Little, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-19-0073

Identifier Type: -

Identifier Source: org_study_id