{"protocolSection":{"identificationModule":{"nctId":"NCT00391430","orgStudyIdInfo":{"id":"P50MH058911","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50MH058911"},"secondaryIdInfos":[{"id":"P50MH058911","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P50MH058911"},{"id":"DATR A3-NSC"}],"organization":{"fullName":"NYU Langone Health","class":"OTHER"},"briefTitle":"Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder","officialTitle":"Cognitive Behavioral Therapy vs. Sertraline in the Treatment of Post Traumatic Stress Disorder"},"statusModule":{"statusVerifiedDate":"2021-06","overallStatus":"TERMINATED","whyStopped":"Difficulty enrolling subjects","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-05"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2009-07","type":"ACTUAL"},"studyFirstSubmitDate":"2006-10-20","studyFirstSubmitQcDate":"2006-10-20","studyFirstPostDateStruct":{"date":"2006-10-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-05-06","resultsFirstSubmitQcDate":"2021-06-30","resultsFirstPostDateStruct":{"date":"2021-07-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-06-30","lastUpdatePostDateStruct":{"date":"2021-07-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"NYU Langone Health","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.","detailedDescription":"Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that were once enjoyable, irritability, and sleep problems. Medication therapy, behavioral therapy, and a combination of both therapies are among the available treatment options for people with PTSD. Cognitive behavioral therapy (CBT), a type of talking therapy that has been shown to be effective in treating PTSD, teaches patients how to alter their thinking to, in turn, improve how they feel. A selective serotonin reuptake inhibitor (SSRI) is a type of medication that has also been effective in treating PTSD. Information about the comparative physiological effects of each of these treatments on people with PTSD is needed. This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI treatment in people with PTSD.\n\nParticipants with and without PTSD will be enrolled in this 12-week, open label study. Following a screening visit to determine eligibility, participants with PTSD will be offered a choice of either CBT or SSRI treatment. Those participants who choose CBT will attend 16 therapy sessions. The first phase of therapy will focus on the development of emotional and interpersonal regulation skills. The second phase will use a modified form of prolonged exposure therapy, which has been effective in reducing symptoms of PTSD. Participants who elect to receive medication will take sertraline, an SSRI that has been safe and effective in treating PTSD. These participants will attend 12 treatment sessions. Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels. All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning. Other outcomes will be assessed throughout the study using questionnaires.\n\nFor information on a related study, please follow this link:\n\nhttp://clinicaltrials.gov/show/NCT00648375"},"conditionsModule":{"conditions":["Post-Traumatic Stress Disorder"],"keywords":["PTSD","Trauma","Sexual Abuse","Sexual Assault"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":39,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Control","type":"NO_INTERVENTION","description":"Participants assigned to the control condition will receive no treatment"},{"label":"Sertraline","type":"ACTIVE_COMPARATOR","description":"Participants will receive treatment with sertraline","interventionNames":["Drug: Sertraline"]},{"label":"CBT","type":"ACTIVE_COMPARATOR","description":"Participants will receive cognitive behavioral therapy","interventionNames":["Behavioral: Cognitive behavioral therapy (CBT)"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks","armGroupLabels":["Sertraline"]},{"type":"BEHAVIORAL","name":"Cognitive behavioral therapy (CBT)","description":"CBT consists of sixteen 1-hour sessions during a period of 12 weeks.","armGroupLabels":["CBT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Salivary Cortisol Levels (Measured Before, During, and After the fMRI)","description":"Salivary cortisol levels (measured before, during, and after the fMRI)","timeFrame":"Measured 3 days before and after treatment and 1 day during fMRI"},{"measure":"Fear Response (Measured During the fMRI)","description":"Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli","timeFrame":"Measured on 1 day during two MRIs"}],"secondaryOutcomes":[{"measure":"Trauma History Inventory (THI)","description":"Assesses the full range of traumatic stressor over lifetime","timeFrame":"Measured 30 minutes before and after treatment"},{"measure":"Clinician-Administered PTSD Scale for DSM-IV (CAPS)","description":"Assesses severity and frequency of PTSD symptoms and provides information for diagnosis","timeFrame":"Measured 30 minutes before and after treatment"},{"measure":"Structured Clinical Interview for DSM-IV I and II (SCID I and II)","description":"Provides assessment of all anxiety and mood disorder diagnoses","timeFrame":"Measured 1 hour before and after treatment"},{"measure":"Panic Disorder Severity Scale (PDSS)","description":"measure of frequency and severity of panic attacks","timeFrame":"Measured 15 minutes before and after treatment"},{"measure":"Clinical Global Impressions Severity Scale","description":"Assesses functional status of individual","timeFrame":"Measured weekly throughout the study"},{"measure":"Clinical Global Impressions Improvement Scale","description":"Assesses improvement in functioning","timeFrame":"Measured weekly throughout the study"},{"measure":"Sociodemographic Questionnaire","description":"social and demographic characteristics of the individual","timeFrame":"Measured at baseline"},{"measure":"Penn State Worry Questionnaire (PSWQ)","description":"assesses worry and rumination","timeFrame":"Measured 10 minutes, before, during, and after treatment"},{"measure":"Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)","description":"self-report measure of PTSD symptoms","timeFrame":"Measured 10 times throughout study"},{"measure":"Brief Symptom Inventory (BSI)","description":"assesses a wide range of symptoms regarding the distress they cause","timeFrame":"Measured 10 times throughout study"},{"measure":"General Expectancy for Negative Mood Regulation (NMR)","description":"assesses ability to regulate mood states","timeFrame":"Measured 3 times throughout study"},{"measure":"State-Trait Anger Expression (STAXI)","description":"assess experience of anger as both a state and trait like phenomenon","timeFrame":"Measured 10 times throughout study"},{"measure":"Toronto Alexithymia Scale (TAS)","description":"assesses difficulty in identifying and naming feelings","timeFrame":"Measured 2 times throughout study"},{"measure":"The State-Trait Anxiety Inventory (STAI)","description":"assesses types and severity of anxiety","timeFrame":"Measured 10 times throughout study"},{"measure":"Beck Depression Inventory (BDI)","description":"assesses type and severity of depression","timeFrame":"Measured 3 times throughout study"},{"measure":"The Inventory of Interpersonal Problems (IIP)","description":"assesses type and severity of interpersonal problems","timeFrame":"Measured 2 times throughout study"},{"measure":"The Social Adjustment Scale - Self Report (SAS-SR)","description":"assesses social adjustment","timeFrame":"Measured 2 times throughout study"},{"measure":"fMRI Safety Information Checklist","description":"review safety information related to fMRI procedure","timeFrame":"Measured 2 times throughout study"},{"measure":"Medical History 12 Months (MH)","description":"assessment of medical problems in past 12 months","timeFrame":"Measured throughout study"},{"measure":"Health Services Utilization Form-12 Months (HSUF)","description":"assessment of type and frequency of use of medical services","timeFrame":"Measured throughout study"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nFor people with PTSD:\n\n* Meets DSM-IV criteria for PTSD\n* Medically healthy\n* Right handed\n* Learned English prior to age 5\n* Agrees to use an effective form of contraception throughout the study\n\nFor healthy controls:\n\n* Medically healthy\n* Right handed\n* Has experienced a qualifying traumatic event\n* Does not meet DSM-IV criteria for present or past PTSD\n* Learned English prior to age 5\n* Agrees to use an effective form of contraception throughout the study\n\nExclusion Criteria:\n\nFor people with PTSD:\n\n* Meets DSM-IV criteria for panic disorder within 6 months prior to study entry\n* Current suicide risk\n* History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar mood disorder, obsessive compulsive disorder (including trichotillomania), or eating disorder\n* Meets DSM-IV criteria for substance use or dependence within the 6 months prior to study entry\n* Any substance abuse within 2 weeks prior to study entry\n* Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) with depressive symptoms secondary to PTSD\n* Current participation in cognitive behavioral psychotherapy that is specifically designed to treat PTSD\n* Concomitant psychoactive medications\n* History of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems\n* Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS\n* Unstable general medical illness requiring intervention (e.g., HIV infection)\n* Pregnant, breastfeeding, or plans to become pregnant\n* Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins\n* History of gastric bypass surgery\n\nFor healthy controls:\n\n* Any history of generalized anxiety disorder or panic disorder\n* Any history of psychotic disorder, bipolar disorder, or cyclothymia\n* Any history of substance abuse or dependence within the 6 months prior to study entry\n* Any substance use within 2 weeks prior to study entry\n* Any other Axis I disorder within the year prior to study entry, including obsessive-compulsive disorder and trichotillomania\n* Unstable general medical illness requiring intervention (e.g., HIV infection)\n* Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins\n* Concomitant psychoactive medications\n* Patients with a history of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems\n* Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS\n* Cognitive impairment or severe Axis II disorder that will likely affect participation in the study\n* Pregnant, breastfeeding, or plans to become pregnant","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Marylene Cloitre, PhD","affiliation":"NYU","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"NYU Institute for Trauma & Resilience","city":"New York","state":"New York","zip":"10016","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"FG001","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"FG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"31"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","groups":[{"id":"BG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"BG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"BG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"39"}]}],"measures":[{"title":"Age, Continuous","description":"Age assessed in years","populationDescription":"Study was terminated due to poor enrollment. Data collected insufficient to conduct meaningful analyses.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Sex: Female, Male","description":"Gender specified by status of either being male or female.","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Salivary Cortisol Levels (Measured Before, During, and After the fMRI)","description":"Salivary cortisol levels (measured before, during, and after the fMRI)","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 3 days before and after treatment and 1 day during fMRI","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"PRIMARY","title":"Fear Response (Measured During the fMRI)","description":"Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured on 1 day during two MRIs","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Trauma History Inventory (THI)","description":"Assesses the full range of traumatic stressor over lifetime","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 30 minutes before and after treatment","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Clinician-Administered PTSD Scale for DSM-IV (CAPS)","description":"Assesses severity and frequency of PTSD symptoms and provides information for diagnosis","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 30 minutes before and after treatment","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Structured Clinical Interview for DSM-IV I and II (SCID I and II)","description":"Provides assessment of all anxiety and mood disorder diagnoses","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 1 hour before and after treatment","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Panic Disorder Severity Scale (PDSS)","description":"measure of frequency and severity of panic attacks","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 15 minutes before and after treatment","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Clinical Global Impressions Severity Scale","description":"Assesses functional status of individual","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured weekly throughout the study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Clinical Global Impressions Improvement Scale","description":"Assesses improvement in functioning","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured weekly throughout the study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Sociodemographic Questionnaire","description":"social and demographic characteristics of the individual","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured at baseline","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Penn State Worry Questionnaire (PSWQ)","description":"assesses worry and rumination","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 10 minutes, before, during, and after treatment","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR)","description":"self-report measure of PTSD symptoms","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 10 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Brief Symptom Inventory (BSI)","description":"assesses a wide range of symptoms regarding the distress they cause","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 10 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"General Expectancy for Negative Mood Regulation (NMR)","description":"assesses ability to regulate mood states","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 3 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"State-Trait Anger Expression (STAXI)","description":"assess experience of anger as both a state and trait like phenomenon","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 10 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Toronto Alexithymia Scale (TAS)","description":"assesses difficulty in identifying and naming feelings","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 2 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"The State-Trait Anxiety Inventory (STAI)","description":"assesses types and severity of anxiety","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 10 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"assesses type and severity of depression","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 3 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"The Inventory of Interpersonal Problems (IIP)","description":"assesses type and severity of interpersonal problems","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 2 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"The Social Adjustment Scale - Self Report (SAS-SR)","description":"assesses social adjustment","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 2 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"fMRI Safety Information Checklist","description":"review safety information related to fMRI procedure","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured 2 times throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Medical History 12 Months (MH)","description":"assessment of medical problems in past 12 months","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Health Services Utilization Form-12 Months (HSUF)","description":"assessment of type and frequency of use of medical services","populationDescription":"Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.","reportingStatus":"POSTED","timeFrame":"Measured throughout study","groups":[{"id":"OG000","title":"Control","description":"Participants assigned to the control condition will receive no treatment"},{"id":"OG001","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks"},{"id":"OG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Up to 4 years","description":"0 participants completed in control arm; therefore 0 participants at risk for adverse events","eventGroups":[{"id":"EG000","title":"Sertraline","description":"Participants will receive treatment with sertraline\n\nSertraline: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks","deathsNumAffected":0,"deathsNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":0,"otherNumAtRisk":3},{"id":"EG001","title":"Control","description":"Participants assigned to the control condition will receive no treatment","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG002","title":"Cognitive Behavioral Therapy","description":"Participants will receive cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT consists of sixteen 1-hour sessions during a period of 12 weeks.","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":0,"otherNumAtRisk":12}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Marylene Cloitre","organization":"NYU Langone","email":"marylene.cloitre@nyulangone.org","phone":"2122632471"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013313","term":"Stress Disorders, Post-Traumatic"},{"id":"D014947","term":"Wounds and Injuries"}],"ancestors":[{"id":"D040921","term":"Stress Disorders, Traumatic"},{"id":"D000068099","term":"Trauma and Stressor Related Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"},{"id":"D015928","term":"Cognitive Behavioral Therapy"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":true}