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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Support as usual | Active Comparator |
| |
| Problem Solving therapy | Experimental |
| |
| ICU diary | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support as usual | Behavioral | This group receives current best practice which includes participation in ICU support groups and provision of community support resources |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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) | 6 months post injury |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months post injury |
| PTSD Checklist for (PCL-5) assessment. |
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Inclusion Criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Deborah M Little, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Problem solving therapy | Behavioral | This group will receive one on one therapy based on identifying stressors and solutions to those stressors |
|
| ICU diary | Behavioral | This group will be provided with a structured written diary that includes identification of stressors and development of solutions to those stressors |
|
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). |
| 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 | 3 months post injury |
| Number of days of hospitalization | Medical record based review of hospital readmission | 6 months post injury |
| Number of infections post discharge | Medical record based review of number of infections after discharge | 6 months post injury |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |