Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Deborah M Little, PhD
713-486-2524
Deborah.M.Little@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Deborah M Little, PhD
(713) 486-2524
Deborah.M.Little@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.