N/A
N=121
Trauma Survivors Outcomes and Support Study IV
Posttraumatic Stress Disorder · Depression · Suicide · Traumatic Brain Injury · Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT01625416 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury — 47.0; 47.0; 43.9; 43.6 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stepped Care Management (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury |
47.0; 47.0; 43.9; 43.6; 41.4; 45.4 | 0.05 |
| PRIMARY Change in Depression Symptoms Over the Course of the Six Months After Injury |
14.3; 15.0; 13.2; 13.8; 12.5; 14.1 | 0.69 |
| PRIMARY Technology Use |
24.76; 16.05 | — |
| PRIMARY Feasibility/Acceptability of Intervention |
37; 33 | — |
| SECONDARY Alcohol Use Problems |
4.5; 4.2; 1.5; 1.0; 2.4; 1.9 | 0.97 |
| SECONDARY Physical Functioning |
47.3; 42.8; 27.9; 27.4; 35.2; 33.6 | 0.71 |
Summary
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.
Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
Eligibility Criteria
Inclusion Criteria
- Score ≥3 on PTSD automated screening algorithm
- Score ≥35 on PTSD checklist (PCL-C)
Exclusion Criteria
- Non-English speaking
- Under 14 years of age
- Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)
- Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
Data sourced from ClinicalTrials.gov (NCT01625416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.