Posttraumatic Stress DisorderTSOS6NCT02335125
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
A study testing Motivational Interviewing, Cognitive Behavioral Therapy Elements and Psychotropic Drugs in people with Posttraumatic Stress Disorder and Depression, run by University of Washington.
Trial summary
The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders
- What is being tested?
- Motivational Interviewing, Cognitive Behavioral Therapy Elements and Psychotropic Drugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient/Emergency Admission for traumatic injury
Who cannot join
- Non-English speaking
- Self-inflicted injury
- Actively psychotic
- Incarcerated or in custody
About this study
The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.
- Conditions
- Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment
- Being tested
- Motivational Interviewing, Cognitive Behavioral Therapy Elements, Psychotropic Drugs, Care Management
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Cognitive Behavioral Therapy ElementsBehavioural
Psychotropic DrugsDrug
Care ManagementOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. Receives: Behavioral: Motivational Interviewing; Behavioral: Cognitive Behavioral Therapy Elements; Drug: Psychotropic Drugs; Other: Care Management |
| Usual Care | No intervention | Only standard care practices will be administered to this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 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.
Measured: Baseline and 1-month
Change From Baseline Alcohol Use Disorders Identification at 1 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.
Measured: Baseline and 1-month
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 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.
Measured: Baseline and 1-month
Secondary outcomes (4)
Change in Functional Status
The investigators will use 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.
Measured: Baseline and 1-month
Patient Health Questionnaire Item 9 Suicide Question
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.
Measured: Baseline and 1-month
Number of Participants Endorsing a Single Item That Assesses Drug Use
Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use.
Measured: Baseline and 1-month
Cognitive Impairment Scale
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.
Measured: Baseline and 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Douglas Zatzick, University of Washington
- Investigators
- Douglas Zatzick, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335125
- Sponsor's protocol ID
- STUDY00010782
- Other IDs
- UH2MH106338
- Acronym
- TSOS6
- Status last verified
- Sep 2020
- First submitted
- 14 Nov 2014
- Last updated
- 11 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
- ClinicalTrials.gov ID
- NCT02335125
- Acronym / sponsor ID
- TSOS6 / STUDY00010782
- Conditions
- Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Posted 11 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational Interviewing, Behavioral: Cognitive Behavioral Therapy Elements, Drug: Psychotropic Drugs, Other: Care ManagementThe intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. |
| Usual Care | No intervention | –Only standard care practices will be administered to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatient/Emergency Admission for traumatic injury
Key exclusion criteria (4 listed)
- Non-English speaking
- Self-inflicted injury
- Actively psychotic
- Incarcerated or in custody
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 |
|---|---|---|
| Motivational Interviewing | Behavioural | Intervention |
| Cognitive Behavioral Therapy Elements | Behavioural | Intervention |
| Psychotropic Drugs | Drug | Intervention |
| Care Management | Other | Intervention |
Primary outcome
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
Time frame: Baseline and 1-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.
Change From Baseline Alcohol Use Disorders Identification at 1 Month
Time frame: Baseline and 1-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.
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month
Time frame: Baseline and 1-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.
4 secondary outcomes
Change in Functional Status
Time frame: Baseline and 1-month
Patient Health Questionnaire Item 9 Suicide Question
Time frame: Baseline and 1-month
Number of Participants Endorsing a Single Item That Assesses Drug Use
Time frame: Baseline and 1-month
Cognitive Impairment Scale
Time frame: Baseline and 1-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Douglas Zatzick, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, Cognitive Behavioral Therapy Elements and Psychotropic Drugs in people with Posttraumatic Stress Disorder and Depression, run by University of Washington.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month (time frame: Baseline and 1-month). 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 11 Sep 2020.