Trial · NCT02655354
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
NCT02655354, Not applicable, Completed, University of Washington; results first posted 2021-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity. Trials, record NCT02655354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02655354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
- NCT number
- NCT02655354
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 635 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life, Pain, Wounds and Injury, Brain Injuries, Chronic Disease
- Interventions
Motivational Interviewing, Cognitive Behavioral Therapy Elements, Care Management, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Venlafaxine, Duloxetine, Mirtazapine, Diphenhydramine, Trazodone, Prazosin
- First posted
- 2016-01-14
- Last updated
- 2021-07-02
- Results first posted
- 2021-07-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN | |
| 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 | score on a scale | MEAN | |
| PRIMARY | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN | |
| 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 | score on a scale | MEAN | |
| SECONDARY | Number of Participants With Suicidal Ideation | Baseline, 3-month, 6-month, 12-month | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Endorsing a Single Item That Assesses Opioid Use | Baseline, 3-month, 6-month, 12-month | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cognitive Impairment Scale | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN | |
| SECONDARY | Brief Pain Inventory | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN | |
| SECONDARY | SF-36 Quality of Life | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN | |
| SECONDARY | TSOS Patient Satisfaction: Overall Health Care | Baseline, 3-month, 6-month, 12-month | score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Intervention | Change from Baseline at 3 Months | -1.65 | Standard Error 0.86 | score on a scale |
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Usual Care | Change from Baseline at 3 Months | 0.08 | Standard Error 0.74 | score on a scale |
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Intervention | Change from Baseline at 6 Months | -4.02 | Standard Error 0.99 | score on a scale |
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Usual Care | Change from Baseline at 6 Months | -1.44 | Standard Error 0.83 | score on a scale |
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Intervention | Change from Baseline at 12 Months | -5.51 | Standard Error 1.18 | score on a scale |
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Usual Care | Change from Baseline at 12 Months | -4.25 | Standard Error 0.97 | score on a scale |
| Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Intervention | Change from Baseline at 3 Months | -0.79 | Standard Error 0.40 | score on a scale |
| Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Usual Care | Change from Baseline at 3 Months | -0.50 | Standard Error 0.35 | score on a scale |
| Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Intervention | Change from Baseline at 6 Months | -1.17 | Standard Error 0.45 | score on a scale |
| Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Usual Care | Change from Baseline at 6 Months | -0.90 | Standard Error 0.38 | score on a scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 265 | |
| Overall Study | STARTED | Usual Care | 370 | |
| Overall Study | COMPLETED | Intervention | 188 | |
| Overall Study | COMPLETED | Usual Care | 289 | |
| Overall Study | NOT COMPLETED | Intervention | 77 | |
| Overall Study | NOT COMPLETED | Usual Care | 81 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Suicidal Ideation | Psychiatric disorders | Intervention | 134 | 265 | |
| other | Suicidal Ideation | Psychiatric disorders | Usual Care | 197 | 370 | |
| serious | Suicide Attempt | Injury, poisoning and procedural complications | Intervention | 9 | 265 | |
| serious | Suicide Attempt | Injury, poisoning and procedural complications | Usual Care | 10 | 370 | |
| serious | Death | General disorders | Intervention | 6 | 265 | |
| serious | Death | General disorders | Usual Care | 3 | 370 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 6 | 265 |
| Total, all-cause mortality | Usual Care | 3 | 370 |
| Total, other adverse events | Intervention | 134 | 265 |
| Total, other adverse events | Usual Care | 197 | 370 |
| Total, serious adverse events | Intervention | 15 | 265 |
| Total, serious adverse events | Usual Care | 13 | 370 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UH3MH106338 | A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity | ZATZICK, DOUGLAS F | UNIVERSITY OF WASHINGTON | NATIONAL INSTITUTE OF MENTAL HEALTH | 2015 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Usual Care: deaths from any cause | Trial comparisons |
| Intervention vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02655354
GET https://conductscience.org/api/trials/v1/NCT02655354/results?page=2