{"protocolSection":{"identificationModule":{"nctId":"NCT01347541","orgStudyIdInfo":{"id":"40069"},"organization":{"fullName":"University of Washington","class":"OTHER"},"briefTitle":"Piloting Acute Care to Primary Care Linkage of Safety Net Patients","officialTitle":"Piloting Acute Care to Primary Care Linkage of Safety Net Patients","acronym":"TSOS III"},"statusModule":{"statusVerifiedDate":"2021-02","overallStatus":"TERMINATED","whyStopped":"Inadequate recruitment","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2011-11","type":"ACTUAL"},"completionDateStruct":{"date":"2011-11","type":"ACTUAL"},"studyFirstSubmitDate":"2011-04-29","studyFirstSubmitQcDate":"2011-05-02","studyFirstPostDateStruct":{"date":"2011-05-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-01-22","resultsFirstSubmitQcDate":"2021-01-22","resultsFirstPostDateStruct":{"date":"2021-02-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-02-18","lastUpdatePostDateStruct":{"date":"2021-03-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Douglas Zatzick","investigatorTitle":"Professor","investigatorAffiliation":"University of Washington"},"leadSponsor":{"name":"University of Washington","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This pilot study will evaluate the implementation of a stepped care intervention that combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications, and information technology innovations at a level 1 trauma center to community linkage components to reduce the symptoms of posttraumatic stress disorder and related comorbidities in injured trauma survivors treated in the emergency department and surgical inpatient settings.","detailedDescription":"The investigators plan to implement a pilot linkage program in which trauma center based care facilitators will use a population-based recruitment strategy to facilitate outpatient follow-up for acutely injured trauma center inpatients and emergency department patients. All patients recruited into the trial will be low income patients with one or more of the following characteristics: being uninsured, low income older adults, low income mothers, and other high risk individuals who lack health insurance. Patients will be linked for care to one of the community health centers participating in Washington State.\n\nIn phase I, patients will be recruited from the trauma center inpatient trauma surgery service and emergency departments. In phase one, no randomization will occur; patients will be linked to one of the community health centers. Patients who consent to the protocol will be assessed in the surgical inpatient units or emergency department. After the baseline assessment, all patients will be immediately assigned a bachelor's, MSW, or RN level care manager. The care managers will elicit and address posttraumatic concerns, and attempt linkage of patients to community programs. Care managers may also deliver motivational interviewing and cognitive behavioral therapy interventions. Patient may also be linked to psychopharmacologic interventions targeting PTSD. Follow-up assessments will occur in the weeks and months after the injury and will assess patterns of health service utilization and symptomatic outcomes. Phase I will establish the feasibility of recruitment and follow-up, acceptability of care management for patients, as well as the pragmatics of linkage to community programs.\n\nPiloting in phase II will depend on the results of phase I; the phase II pilot will build and extend upon phase I. In phase II, patients will be randomized to either intervention or control conditions. Patients randomized to the intervention condition will be met by a care manager who may address patients' initial needs and concerns. Care managers may also deliver Motivational Interviewing and Cognitive Behavioral Therapy interventions. Patients may also be linked to psychopharmacologic interventions targeting PTSD. The care manager will attempt to link patients to participating community health centers. Linkages may occur by the telephone, or through web-based clinical registry tools that are under development by the intervention team. Some linkages may occur in person. To determine if intervention patients are successfully linked more frequently than controls, all patients will be followed from the time of designation at hospital admission to outpatient primary care appointments. Follow-up outcome assessments will occur in the weeks and months post-injury and will includes assessments of patterns of health service utilization, function, and symptomatic outcomes."},"conditionsModule":{"conditions":["Posttraumatic Stress Disorder"],"keywords":["PTSD"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":4,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Stepped care","type":"EXPERIMENTAL","description":"Combination of behavioral therapy and drug therapy","interventionNames":["Behavioral: Cognitive Behavioral Therapy","Behavioral: Motivational Interviewing","Drug: FDA-Approved Anti-Anxiety Medications"]},{"label":"Standard care provided to injured trauma survivors","type":"ACTIVE_COMPARATOR","interventionNames":["Behavioral: Standard Care Control"]}],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy","description":"Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.","armGroupLabels":["Stepped care"],"otherNames":["CBT"]},{"type":"BEHAVIORAL","name":"Motivational Interviewing","description":"Motivational interviewing is designed to address alcohol and drug use.","armGroupLabels":["Stepped care"],"otherNames":["MI"]},{"type":"DRUG","name":"FDA-Approved Anti-Anxiety Medications","description":"Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.","armGroupLabels":["Stepped care"]},{"type":"BEHAVIORAL","name":"Standard Care Control","description":"Standard care control includes the usual treatment for injured trauma survivors","armGroupLabels":["Standard care provided to injured trauma survivors"],"otherNames":["BA"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline Alcohol Use Disorders Identification at 1 Month","description":"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.","timeFrame":"Baseline, Up to 12 months after injury"},{"measure":"Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month","description":"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.","timeFrame":"Baseline, Up to 12 months after injury"},{"measure":"Change in Functional Status at 1 Month","description":"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.","timeFrame":"Baseline, Up to 12 months after injury"}],"secondaryOutcomes":[{"measure":"Increased Satisfaction With Global Care","description":"Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)","timeFrame":"Up to 12 months after injury"},{"measure":"Injury Relapse","description":"Assessed using Healthcare Utilization Questions (NSCOT)","timeFrame":"Up to 5 years after injury"},{"measure":"Work, Disability, and Legal Outcomes","description":"Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)","timeFrame":"Up to 12 months after injury"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* English-speaking\n* Admitted to Harborview Medical Center with injuries sufficiently severe enough to require inpatient admission\n* Experienced a traumatic injury\n* Exhibits symptoms of PTSD while in the hospital ward\n* Low-income\n\nExclusion Criteria:\n\n* History of head, spinal, or other injury that may prevent participation in the ward interview\n* Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania\n* Currently incarcerated\n* Likely to face criminal charges\n* Lives outside of the state of Washington\n* Not low-income","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Douglas Zatzick, MD","affiliation":"University of Washington","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Harborview Medical Center","city":"Seattle","state":"Washington","zip":"98104","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"11427243","type":"BACKGROUND","citation":"Zatzick DF, Roy-Byrne P, Russo JE, Rivara FP, Koike A, Jurkovich GJ, Katon W. Collaborative interventions for physically injured trauma survivors: a pilot randomized effectiveness trial. Gen Hosp Psychiatry. 2001 May-Jun;23(3):114-23. doi: 10.1016/s0163-8343(01)00140-2."},{"pmid":"15123495","type":"BACKGROUND","citation":"Zatzick D, Roy-Byrne P, Russo J, Rivara F, Droesch R, Wagner A, Dunn C, Jurkovich G, Uehara E, Katon W. A randomized effectiveness trial of stepped collaborative care for acutely injured trauma survivors. Arch Gen Psychiatry. 2004 May;61(5):498-506. doi: 10.1001/archpsyc.61.5.498."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"FG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"BG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"37.33","spread":"18.01"},{"groupId":"BG001","value":"31","spread":"NA","comment":"Only one patient was recruited into the control arm, so standard deviation cannot be calculated."},{"groupId":"BG002","value":"35.75","spread":"15.04"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline Alcohol Use Disorders Identification at 1 Month","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Up to 12 months after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","lowerLimit":"-7.9","upperLimit":"4.6"},{"groupId":"OG001","value":"-2.0","lowerLimit":"NA","upperLimit":"NA","comment":"Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated."}]}]}]},{"type":"PRIMARY","title":"Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Up to 12 months after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.0","lowerLimit":"-55.3","upperLimit":"47.3"},{"groupId":"OG001","value":"-14.0","lowerLimit":"NA","upperLimit":"NA","comment":"Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated."}]}]}]},{"type":"PRIMARY","title":"Change in Functional Status at 1 Month","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Up to 12 months after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","lowerLimit":"-11.5","upperLimit":"7.8"},{"groupId":"OG001","value":"4.0","lowerLimit":"NA","upperLimit":"NA","comment":"Only one participant was recruited for the standard care arm of this pilot, so no confidence interval can be calculated."}]}]}]},{"type":"SECONDARY","title":"Increased Satisfaction With Global Care","description":"Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)","populationDescription":"Data were not collected","reportingStatus":"POSTED","timeFrame":"Up to 12 months after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Injury Relapse","description":"Assessed using Healthcare Utilization Questions (NSCOT)","populationDescription":"Data were not collected","reportingStatus":"POSTED","timeFrame":"Up to 5 years after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Work, Disability, and Legal Outcomes","description":"Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)","populationDescription":"Data were not collected","reportingStatus":"POSTED","timeFrame":"Up to 12 months after injury","groups":[{"id":"OG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care."},{"id":"OG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Stepped Care","description":"Combination of behavioral therapy and drug therapy\n\nCognitive Behavioral Therapy: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.\n\nMotivational Interviewing: Motivational interviewing is designed to address alcohol and drug use.\n\nFDA-Approved Anti-Anxiety Medications: Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.","seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":0,"otherNumAtRisk":3},{"id":"EG001","title":"Standard Care Provided to Injured Trauma Survivors","description":"Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors","seriousNumAffected":0,"seriousNumAtRisk":1,"otherNumAffected":0,"otherNumAtRisk":1}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr, Douglas Zatzick","organization":"University of Washington School of Medicine","email":"dzatzick@uw.edu","phone":"206-744-6701"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013313","term":"Stress Disorders, Post-Traumatic"}],"ancestors":[{"id":"D040921","term":"Stress Disorders, Traumatic"},{"id":"D000068099","term":"Trauma and Stressor Related Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D015928","term":"Cognitive Behavioral Therapy"},{"id":"D062405","term":"Motivational Interviewing"}],"ancestors":[{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D037001","term":"Directive Counseling"},{"id":"D003376","term":"Counseling"},{"id":"D008605","term":"Mental Health Services"},{"id":"D006296","term":"Health Services"},{"id":"D005159","term":"Health Care Facilities Workforce and Services"}]}},"hasResults":true}