Caregiver BurnoutNCT04293016
Building Resilience In Caregivers of Trauma Survivors
A study testing Support as usual, Problem solving therapy and ICU diary in people with Caregiver Burnout, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Support as usual, Problem solving therapy and ICU diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 17 and 65 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- Support as usual, Problem solving therapy, ICU diary
- Keywords
- PTSD, Depression, substance use
- Medical subject headings
- Caregiver Burden, Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support as usualBehavioural
This group receives current best practice which includes participation in ICU support groups and provision of community support resources
Problem solving therapyBehavioural
This group will receive one on one therapy based on identifying stressors and solutions to those stressors
ICU diaryBehavioural
This group will be provided with a structured written diary that includes identification of stressors and development of solutions to those stressors
| Study group | Role | What they receive |
|---|---|---|
| Support as usual | Active comparator | Not described Receives: Behavioral: Support as usual |
| Problem Solving therapy | Experimental | Not described Receives: Behavioral: Problem solving therapy |
| ICU diary | Experimental | Not described Receives: Behavioral: ICU diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
Measured: 6 months post injury
Secondary outcomes (5)
The center for epidemiologic studies of depression (CESD-R )
Depression in caregivers as assessed by the CESD-R tool The CESD-R scale has 20 items and each is measured from 0(not at all) to 4(nearly every day for 2 weeks)
Measured: 3 months post injury
PTSD Checklist for (PCL-5) assessment.
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).
Measured: 3 months post injury
The Alcohol Use Disorders identification Test (AUDIT):
Alcohol use problems in caregivers as assessed by the AUDIT scale This is a 10-item screening tool and is rated between 0-4-the higher number indicating a worse outcome
Measured: 3 months post injury
Number of days of hospitalization
Medical record based review of hospital readmission
Measured: 6 months post injury
Number of infections post discharge
Medical record based review of number of infections after discharge
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Mar 2022
- Primary completion18 Aug 2024 (estimated)
- Study completion26 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Deborah M Little, The University of Texas Health Science Center, Houston
- Investigators
- Deborah M Little, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293016
- Sponsor's protocol ID
- HSC-MS-19-0073
- Status last verified
- May 2024
- First submitted
- 28 Feb 2020
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience In Caregivers of Trauma Survivors
- ClinicalTrials.gov ID
- NCT04293016
- Acronym / sponsor ID
- HSC-MS-19-0073
- Conditions
- Caregiver Burnout
- Keywords
- PTSD, Depression, substance use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Aug 2024 (estimated)
- Study completion
- 26 Aug 2024 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Support as usual | Active comparator | Behavioral: Support as usual |
| Problem Solving therapy | Experimental | Behavioral: Problem solving therapy |
| ICU diary | Experimental | Behavioral: ICU diary |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support as usualThis group receives current best practice which includes participation in ICU support groups and provision of community support resources | Behavioural | Support as usual |
| Problem solving therapyThis group will receive one on one therapy based on identifying stressors and solutions to those stressors | Behavioural | Problem Solving therapy |
| ICU diaryThis group will be provided with a structured written diary that includes identification of stressors and development of solutions to those stressors | Behavioural | ICU diary |
Primary outcome
Short form survey (SF-12)
Time frame: 6 months post injury
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.
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: 6 months post injury
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).
The Hamilton Depression Rating Scale (HAM-D)
Time frame: 6 months post injury
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)
5 secondary outcomes
The center for epidemiologic studies of depression (CESD-R )
Time frame: 3 months post injury
PTSD Checklist for (PCL-5) assessment.
Time frame: 3 months post injury
The Alcohol Use Disorders identification Test (AUDIT):
Time frame: 3 months post injury
Number of days of hospitalization
Time frame: 6 months post injury
Number of infections post discharge
Time frame: 6 months post injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah M Little, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support as usual, Problem solving therapy and ICU diary in people with Caregiver Burnout, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short form survey (SF-12) (time frame: 6 months post injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.