Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT01459705
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure
Sponsor:
Organization:
Raw JSON
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Gahm, PhD', 'organization': 'DCoE'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months. From time of baseline visit to final follow up visit', 'eventGroups': [{'id': 'EG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.', 'otherNumAtRisk': 54, 'otherNumAffected': 12, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.', 'otherNumAtRisk': 54, 'otherNumAffected': 15, 'seriousNumAtRisk': 54, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'increase in flashbacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocated Shoulder', 'notes': 'Shoulder dislocation during racket ball which was in in vivo homework exercise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'exacerbation of neck and back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'intermittent stomach ache and diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased intrusive memories', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'increased anxiety around weapons', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'syncopal episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash from ECG lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'alcohol consumption', 'notes': 'Alcohol consumption after session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'self percieved persecution', 'notes': 'starving self, vague suicidal ideation and homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization - psychiatric', 'notes': "All three SAE's were for psychiatric hospitalization - not related to study", 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'OG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}, {'id': 'OG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '78.28', 'spread': '16.35', 'groupId': 'OG000'}, {'value': '80.44', 'spread': '16.23', 'groupId': 'OG001'}, {'value': '78.89', 'spread': '16.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline scores on the CAPS-W (last week reference)'}, {'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'OG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}, {'id': 'OG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '65.03', 'spread': '29.19', 'groupId': 'OG000'}, {'value': '71.19', 'spread': '23.27', 'groupId': 'OG001'}, {'value': '74.73', 'spread': '21.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided data at mid treatment'}, {'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'OG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}, {'id': 'OG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '44.28', 'spread': '33.73', 'groupId': 'OG000'}, {'value': '57.07', 'spread': '32.32', 'groupId': 'OG001'}, {'value': '68.06', 'spread': '24.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-22.34', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.69', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-13.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.77', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '9.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.11', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided outcome data at post treatment'}, {'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'OG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.63', 'spread': '31.80', 'groupId': 'OG000'}, {'value': '55.88', 'spread': '31.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '15.07', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.03', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 week follow up', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'OG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.33', 'spread': '28.49', 'groupId': 'OG000'}, {'value': '54.47', 'spread': '28.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '13.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.70', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '26 Week follow up', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist- Civilian (PCL-C)', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': 'Screening Visit(Day 1)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stigma Measure (PSS)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'Stigma will be measured using a 5 question assessment scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Risk Assessment', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Behavior and Sympton Identification Scale (BASIS-24)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 1(week 1)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist (PCL-C)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist (PCL-C)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist (PCL-C)', 'timeFrame': '12 week follow up', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist (PCL-C)', 'timeFrame': '26 week follow up', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '12 Week follow up', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '26 Week follow up', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '12 Week follow up', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '26 Week follow up', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '12 Week follow up', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '26 Week follow up', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stigma Measure (PSS)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'Stigma will be measured using a 5 question assessment scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stigma Measure (PSS)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'Stigma will be measured using a 5 question assessment scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stigma Measure (PSS)', 'timeFrame': '12 week follow up', 'description': 'Stigma will be measured using a 5 question assessment scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stigma Measure (PSS)', 'timeFrame': '26 week follow up', 'description': 'Stigma will be measured using a 5 question assessment scale.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Risk Assessment', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Risk Assessment', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Risk Assessment', 'timeFrame': '12 Week follow up', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Suicide Risk Assessment', 'timeFrame': '26 Week follow up', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '12 week follow up', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '26 week follow up', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': '12 week follow up', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'BASIS-24', 'timeFrame': '26 week follow up', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Intent to Attend', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'This is a measure to assess the intent to complete study procedures.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'FG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}, {'id': 'FG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.\n\nProlonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.'}, {'id': 'BG001', 'title': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.\n\nVirtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.'}, {'id': 'BG002', 'title': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.\n\nWaitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.89', 'spread': '7.09', 'groupId': 'BG000'}, {'value': '29.52', 'spread': '6.47', 'groupId': 'BG001'}, {'value': '30.39', 'spread': '6.45', 'groupId': 'BG002'}, {'value': '30.27', 'spread': '6.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants randomized to a treatment arm included in baseline data analysis'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2011-10-24', 'resultsFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-09', 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.'}, {'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.'}, {'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.'}, {'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': '12 week follow up', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.'}, {'measure': 'Clinician-Administered PTSD Scale (CAPS)', 'timeFrame': '26 Week follow up', 'description': 'The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.'}], 'secondaryOutcomes': [{'measure': 'PTSD Checklist- Civilian (PCL-C)', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.'}, {'measure': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.'}, {'measure': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': 'Screening Visit(Day 1)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma."}, {'measure': 'Perceived Stigma Measure (PSS)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'Stigma will be measured using a 5 question assessment scale.'}, {'measure': 'Suicide Risk Assessment', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.'}, {'measure': 'Behavior and Sympton Identification Scale (BASIS-24)', 'timeFrame': 'Screening Visit(Day 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Screening Visit (Day 1)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 1(week 1)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 1 (week 1)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'PTSD Checklist (PCL-C)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.'}, {'measure': 'PTSD Checklist (PCL-C)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.'}, {'measure': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.'}, {'measure': 'PTSD Checklist (PCL-C)', 'timeFrame': '12 week follow up', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.'}, {'measure': 'PTSD Checklist (PCL-C)', 'timeFrame': '26 week follow up', 'description': 'The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.'}, {'measure': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.'}, {'measure': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '12 Week follow up', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.'}, {'measure': 'Primary Care PTSD Screen (PC-PTSD)', 'timeFrame': '26 Week follow up', 'description': 'The PC-PTSD is a four-item measure designed to screen for PTSD.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '12 Week follow up', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': '26 Week follow up', 'description': 'This self report measure of depression contains 21 items that are rated on a 4 point scale.'}, {'measure': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma."}, {'measure': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma."}, {'measure': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '12 Week follow up', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma."}, {'measure': 'Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)', 'timeFrame': '26 Week follow up', 'description': "The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma."}, {'measure': 'Perceived Stigma Measure (PSS)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'Stigma will be measured using a 5 question assessment scale.'}, {'measure': 'Perceived Stigma Measure (PSS)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'Stigma will be measured using a 5 question assessment scale.'}, {'measure': 'Perceived Stigma Measure (PSS)', 'timeFrame': '12 week follow up', 'description': 'Stigma will be measured using a 5 question assessment scale.'}, {'measure': 'Perceived Stigma Measure (PSS)', 'timeFrame': '26 week follow up', 'description': 'Stigma will be measured using a 5 question assessment scale.'}, {'measure': 'Suicide Risk Assessment', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Suicide Risk Assessment', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Suicide Risk Assessment', 'timeFrame': '12 Week follow up', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Suicide Risk Assessment', 'timeFrame': '26 Week follow up', 'description': 'Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '12 week follow up', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '26 week follow up', 'description': 'The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': '5 weeks (or after treatment session 10)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': '12 week follow up', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'BASIS-24', 'timeFrame': '26 week follow up', 'description': 'To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Subjective Units of Distress (SUDs)', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 2 (week 1)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 3 (week 2)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 4 (week 2)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 5 (week 2.5)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 6 (week 3)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 7 (week 4)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 8 (week 4)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 9 (week 5)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': 'Treatment session 10 (week 5)', 'description': 'This is a measure to assess the intent to complete study procedures.'}, {'measure': 'Intent to Attend', 'timeFrame': '2.5 weeks (or after treatment session 5)', 'description': 'This is a measure to assess the intent to complete study procedures.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Combat Disorders', 'Exposure Therapy', 'Army Personnel'], 'conditions': ['Stress Disorders', 'Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '16891607', 'type': 'BACKGROUND', 'citation': 'Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052.'}, {'pmid': '11561934', 'type': 'BACKGROUND', 'citation': 'Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22. doi: 10.4088/jcp.v62n0808.'}, {'pmid': '14622073', 'type': 'BACKGROUND', 'citation': 'Koenen KC, Stellman JM, Stellman SD, Sommer JF Jr. Risk factors for course of posttraumatic stress disorder among Vietnam veterans: a 14-year follow-up of American Legionnaires. J Consult Clin Psychol. 2003 Dec;71(6):980-6. doi: 10.1037/0022-006X.71.6.980.'}, {'pmid': '12924676', 'type': 'BACKGROUND', 'citation': 'Bryant RA, Moulds ML, Guthrie RM, Dang ST, Nixon RD. Imaginal exposure alone and imaginal exposure with cognitive restructuring in treatment of posttraumatic stress disorder. J Consult Clin Psychol. 2003 Aug;71(4):706-12. doi: 10.1037/0022-006x.71.4.706.'}, {'pmid': '10761678', 'type': 'BACKGROUND', 'citation': 'Foa EB. Psychosocial treatment of posttraumatic stress disorder. J Clin Psychiatry. 2000;61 Suppl 5:43-8; discussion 49-51.'}, {'pmid': '9046566', 'type': 'BACKGROUND', 'citation': 'Foa EB, Meadows EA. Psychosocial treatments for posttraumatic stress disorder: a critical review. Annu Rev Psychol. 1997;48:449-80. doi: 10.1146/annurev.psych.48.1.449.'}, {'pmid': '9479673', 'type': 'BACKGROUND', 'citation': 'Carlson JG, Chemtob CM, Rusnak K, Hedlund NL, Muraoka MY. Eye movement desensitization and reprocessing (EDMR) treatment for combat-related posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):3-24. doi: 10.1023/A:1024448814268.'}, {'pmid': '9690185', 'type': 'BACKGROUND', 'citation': 'Sherman JJ. Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials. J Trauma Stress. 1998 Jul;11(3):413-35. doi: 10.1023/A:1024444410595.'}, {'pmid': '15846661', 'type': 'BACKGROUND', 'citation': 'Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003388. doi: 10.1002/14651858.CD003388.pub2.'}, {'pmid': '12182270', 'type': 'BACKGROUND', 'citation': 'Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.'}, {'pmid': '2871574', 'type': 'BACKGROUND', 'citation': 'Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.'}, {'pmid': '11074232', 'type': 'BACKGROUND', 'citation': 'Delahanty DL, Raimonde AJ, Spoonster E. 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JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.'}, {'pmid': '17353495', 'type': 'RESULT', 'citation': 'Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82. doi: 10.1001/archinte.167.5.476.'}]}, 'descriptionModule': {'briefSummary': 'This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.', 'detailedDescription': "The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD diagnosis as assessed by CAPS\n* history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF)\n* non sexually based deployment related trauma\n* three or more months since index trauma\n* stable on psychotropic medication for 30 days\n\nExclusion Criteria:\n\n* index trauma in the last three months\n* history of schizophrenia, other psychotic or bipolar disorder\n* history of organic brain disorder\n* suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months\n* ongoing threatening situation\n* current drug or alcohol dependence\n* history of seizures\n* prior history of PE for PTSD\n* other current psychotherapy\n* physical condition that interferes with proper use of Virtual Reality head mounted display\n* history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder'}, 'identificationModule': {'nctId': 'NCT01459705', 'acronym': 'VRPE Extension', 'briefTitle': 'Comparing Virtual Reality Exposure Therapy to Prolonged Exposure', 'organization': {'class': 'FED', 'fullName': 'National Center for Telehealth and Technology'}, 'officialTitle': 'Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '112226'}, 'secondaryIdInfos': [{'id': 'W81XWH-11-2-0007', 'type': 'OTHER_GRANT', 'domain': 'USMRMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prolonged Exposure Therapy (PE)', 'description': 'The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.', 'interventionNames': ['Behavioral: Prolonged Exposure Therapy (PE)']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Exposure Therapy (VRET)', 'description': 'The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.', 'interventionNames': ['Behavioral: Virtual Reality Exposure Therapy (VRET)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Waitlist', 'description': 'The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.', 'interventionNames': ['Behavioral: Waitlist']}], 'interventions': [{'name': 'Prolonged Exposure Therapy (PE)', 'type': 'BEHAVIORAL', 'otherNames': ['PE'], 'description': 'Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.', 'armGroupLabels': ['Prolonged Exposure Therapy (PE)']}, {'name': 'Virtual Reality Exposure Therapy (VRET)', 'type': 'BEHAVIORAL', 'otherNames': ['VRE', 'VRET'], 'description': 'Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.', 'armGroupLabels': ['Virtual Reality Exposure Therapy (VRET)']}, {'name': 'Waitlist', 'type': 'BEHAVIORAL', 'otherNames': ['WL', 'Waitlist Control Group'], 'description': 'This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation', 'armGroupLabels': ['Waitlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28307', 'city': 'Fort Bragg', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Womack Clinical Psychology Service', 'geoPoint': {'lat': 35.139, 'lon': -79.00603}}], 'overallOfficials': [{'name': 'Gregory A Gahm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DCoE- National Center for Telehealth and Technology'}, {'name': 'Greg Reger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DCoE - National Center for Telehealth and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Telehealth and Technology', 'class': 'FED'}, 'collaborators': [{'name': 'The Geneva Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}