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Problem Solving Therapy for Caregiver Burden

N/A
Waitlist Available
Led By Deborah M Little, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Trauma patient must be able to communicate verbally
Caregiver and patient must report English as a primary language
Must not have
Patient is not between 18 and 65 years of age
Patient is not currently admitted to the ICU and or is not expected to remain in the ICU for 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post injury
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare problem solving therapy to just an ICU diary in order to see which better reduces depression, anxiety, and substance use for caregivers following a critical injury to a loved one.

Who is the study for?
This trial is for English-speaking caregivers of trauma patients with severe head injuries, currently in the ICU and expected to survive. Caregivers must be close friends or family anticipating a supportive role post-discharge. Both patient and caregiver must consent.
What is being tested?
The study tests if problem-solving therapy reduces depression, anxiety, and substance use in caregivers compared to usual support or using an ICU diary as interventions after critical injury of a loved one.
What are the potential side effects?
There are no direct medical side effects from participating in this trial as it involves psychological support methods rather than medication. However, participants may experience emotional discomfort discussing their experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can speak and communicate verbally.
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English is my primary language.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am either younger than 18 or older than 65.
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I am not in the ICU nor expected to be for the next 48 hours.
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I won't need help before leaving the hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Posttraumatic Stress Disorder Checklist (PCL-5)
Short form survey (SF-12)
Mental Depression
Secondary study objectives
Number of days of hospitalization
Number of infections post discharge
PTSD Checklist for (PCL-5) assessment.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Problem Solving therapyExperimental Treatment1 Intervention
Group II: ICU diaryExperimental Treatment1 Intervention
Group III: Support as usualActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Problem solving therapy
2004
N/A
~80
ICU diary
2015
N/A
~720

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
343,989 Total Patients Enrolled
United States Department of DefenseFED
909 Previous Clinical Trials
333,396 Total Patients Enrolled
Deborah M Little, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

problem solving therapy Clinical Trial Eligibility Overview. Trial Name: NCT04293016 — N/A
Caregiver Burnout Research Study Groups: ICU diary, Problem Solving therapy, Support as usual
Caregiver Burnout Clinical Trial 2023: problem solving therapy Highlights & Side Effects. Trial Name: NCT04293016 — N/A
problem solving therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04293016 — N/A
~82 spots leftby Nov 2025
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