Trial · NCT02655354
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD. |
| Primary | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome. |
| Primary | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. |
| Primary | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. |
| Secondary | Number of Participants With Suicidal Ideation | Baseline, 3-month, 6-month, 12-month | Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome. |
| Secondary | Number of Participants Endorsing a Single Item That Assesses Opioid Use | Baseline, 3-month, 6-month, 12-month | Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use. |
| Secondary | Cognitive Impairment Scale | Baseline, 3-month, 6-month, 12-month | The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome. |
| Secondary | Brief Pain Inventory | Baseline, 3-month, 6-month, 12-month | A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain. |
| Secondary | SF-36 Quality of Life | Baseline, 3-month, 6-month, 12-month | The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health. |
| Secondary | TSOS Patient Satisfaction: Overall Health Care | Baseline, 3-month, 6-month, 12-month | Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. |
| Secondary | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | Baseline, 3-month, 6-month, 12-month | Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use. |
| Secondary | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | Baseline, 3-month, 6-month, 12-month | Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use. |
| Secondary | TSOS Patient Satisfaction: Mental Health Care | Baseline, 3 Month, 6 Month, 12 Month | Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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