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Problem Solving Therapy for Caregiver Burden

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post injury
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I can speak and communicate verbally.
Select...
English is my primary language.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Traumatic Stress Disorder
Mental Depression
short form survey (SF-12)
Secondary outcome measures
Number of days of hospitalization
Number of infections post discharge
PTSD Checklist for (PCL-5) assessment.
+2 more

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
ICU diary
2015
N/A
~720
problem solving therapy
2011
N/A
~20

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,697 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,299 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities to join this investigation?

"Confirmed - clinicaltrials.gov confirms that this medical study, which was originally posted on March 1st 2022, is still actively seeking participants. The trial's details were last adjusted in mid-April of the same year."

Answered by AI

Is it possible for me to enroll in this investigation?

"This clinical trial is seeking 300 individuals with burnout, ranging in age from 18 to 70. Applicants must meet the following requirements: be able to grant informed consent; provide two forms of contact information; communicate fluently in English; have a documented history of trauma admission directly into an ICU unit, lasting for at least 48 hours and expected survival exceeding 96 hours after admittance; possess an abbreviated injury score greater than 3 (classified as severe or critical); demonstrate verbal communication capability; anticipate assuming a caregiver role post-discharge if they are close relatives or friends of the patient admitted to ICU. Additionally, those who do"

Answered by AI

Are geriatric patients eligible for enrollment in the research trial?

"The parameters of this medical trial mandates that an individual should be between 18 to 70 years in order to participate. There are 14 clinical trials catering specifically for minors and 89 studies available for senior citizens."

Answered by AI

What is the participant count for this experiment?

"Correct. According to the clinicaltrials.gov, this medical study is presently recruiting participants; it was initially posted on March 1st 2022 and recently updated on April 18th 2022. The trial requires 300 patients from a single site."

Answered by AI

What goals has this research been designed to accomplish?

"The principal assessment used to measure the success of this trial over a 6-month period post injury is The Hamilton Depression Rating Scale (HAM-D). Secondary metrics encompass hospitalization days, Alcohol Use Disorders identification Test (AUDIT), and PTSD Checklist for (PCL-5) evaluation. AUDIT is a 10-item questionnaire that ranks from 0 up to 4; higher scores reflect poorer outcomes. PCL-5 evaluates how much participants have been troubled by PTSD symptoms during treatment on a scale ranging from 'not at all' to 'extremely'."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Building Resilience In Caregivers of Trauma Survivors
Deborah M Little 2022. "Building Resilience In Caregivers of Trauma Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04293016.
~41 spots leftby Aug 2024
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