Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00288860
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2006-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'craig.rosen@va.gov', 'phone': '650-493-5000', 'title': 'Craig S. Rosen', 'phoneExt': '22812', 'organization': 'Nationa Center for PTSD Dissemination & Training Division'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Telephone Monitoring', 'description': 'Telephone monitoring as augmentation to treatment as usual\n\nTelephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)', 'otherNumAtRisk': 412, 'otherNumAffected': 1, 'seriousNumAtRisk': 412, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Treatment-As-Usual', 'description': 'Treatment as usual\n\nTreatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 425, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Phone telephone care management upsetting', 'notes': 'Telephone Monitoring arm: Participant was sufficiently upset by telephone calls to ask to discontinue intervention. Treatment as Usual arm: Not applicable (0 subjects at risk) because did not receive this intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death doe to causes not known', 'notes': 'Cause of death not specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for cardiology or chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Scheduled laminotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalized for cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrest or incarceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Admitted to nursing home - reason not known', 'stats': [{'groupId': 'EG000', 'numAtRisk': 412, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Monitoring', 'description': 'Telephone monitoring as augmentation to treatment as usual\n\nTelephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)'}, {'id': 'OG001', 'title': 'Treatment as Usual', 'description': 'Treatment as usual\n\nTreatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)'}], 'classes': [{'title': 'PTSD Symptoms (PTSD Checklist)', 'categories': [{'measurements': [{'value': '63.9', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Aggressive Behavior', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Alcohol Problems (ASI)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Drug Problems (ASI)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post-discharge (8 months post intervention)', 'description': 'Higher scores are worse outcomes on all four measures:\n\nAggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms, Subjective Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Monitoring', 'description': 'Telephone monitoring as augmentation to treatment as usual\n\nTelephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)'}, {'id': 'OG001', 'title': 'Treatment-As-Usual', 'description': 'Treatment as usual\n\nTreatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)'}], 'classes': [{'title': 'Depression (CES-D)', 'categories': [{'measurements': [{'value': '38.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Quality of Life', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post-discharge (8 months post intervention)', 'description': 'Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rehospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telephone Monitoring', 'description': 'Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.\n\nTelephone monitoring: Three months of biweekly telephone monitoring and support\n\nTAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)'}, {'id': 'OG001', 'title': 'Treatment-As-Usual', 'description': 'Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.\n\nTAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post discharge', 'description': 'Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telephone Monitoring', 'description': 'Telephone monitoring as augmentation to treatment as usual\n\nTelephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)'}, {'id': 'FG001', 'title': 'Treatment-As-Usual', 'description': 'Treatment as usual\n\nTreatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '412'}, {'groupId': 'FG001', 'numSubjects': '425'}]}, {'type': 'Completed Intake Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '408'}, {'groupId': 'FG001', 'numSubjects': '417'}]}, {'type': 'Completed 4 Month fu Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'Completed 12 Month fu Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '310 completed either 4 or 12 month survey. Used all with intake (n = 408) in intent-to-treat.', 'groupId': 'FG000', 'numSubjects': '310'}, {'comment': '328 completed 4 or 12 month survey. Used all with intake (n=417) in intent to treat.', 'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Did not complete intake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '71'}]}]}], 'recruitmentDetails': 'Veterans entering treatment in five 30-to-90 day residential treatment programs for posttraumatic stress disorder', 'preAssignmentDetails': '926 patients were initially consented into the study. 6 withdrew prior to randomization, and 83 met exclusion criteria after being consent (usually because they were discharged to another inpatient program, not to outpatient care). This left 837 subjects to be randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '837', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Telephone Monitoring', 'description': 'Telephone monitoring as augmentation to treatment as usual\n\nTelephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)'}, {'id': 'BG001', 'title': 'Treatment-As-Usual', 'description': 'Treatment as usual\n\nTreatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '0.86', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '0.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': 'Asian American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Race/ethnicity missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Iraq or Afghanistan veteran', 'classes': [{'title': 'Iraq/Afghanistan veteran', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Served prior to current Iraq/Afghanistan conflicts', 'categories': [{'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '609', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Veterans entering residential treatment for posttraumatic stress disorder.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 837}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2006-02-06', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-22', 'studyFirstPostDateStruct': {'date': '2006-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms', 'timeFrame': '12 months post-discharge (8 months post intervention)', 'description': 'Higher scores are worse outcomes on all four measures:\n\nAggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)'}, {'measure': 'Rehospitalization', 'timeFrame': '12 months post discharge', 'description': 'Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms, Subjective Quality of Life', 'timeFrame': '12 months post-discharge (8 months post intervention)', 'description': 'Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['telemedicine', 'treatment compliance', 'mental health'], 'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '23117443', 'type': 'RESULT', 'citation': 'Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.'}, {'pmid': '23047625', 'type': 'RESULT', 'citation': 'Belsher BE, Tiet QQ, Garvert DW, Rosen CS. Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment. J Trauma Stress. 2012 Oct;25(5):494-502. doi: 10.1002/jts.21747. Epub 2012 Oct 9.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test whether providing PTSD patients additional support by telephone (in addition to usual outpatient care) after they discharge from residential treatment improves those patients' outcomes and keeps them out of the hospital longer.", 'detailedDescription': "Background: Poor compliance with aftercare may contribute to high rates of relapse and rehospitalization among Veterans who received residential treatment for posttraumatic stress disorder (PTSD). Telephone case monitoring has been shown to improve treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been tested in PTSD patients.\n\nObjectives: This multisite randomized controlled trial tested whether augmenting usual aftercare with telephone monitoring improved resulted in 1) improved clinical outcomes (less violence, substance use, and PTSD symptoms; 2) longer time to rehospitalization; 3) better compliance with aftercare in the year after discharge from residential treatment for PTSD.\n\nMethods: This trial recruited 837 subjects from 6 PTSD residential treatment programs at 5 VA medical centers, 94.7% of the 884 projected. Patients who completed at least 14 days of residential PTSD treatment and discharged to VA outpatient care were eligible to participate. Subjects were randomized to usual aftercare care (n = 425) or usual aftercare plus biweekly telephone case monitoring calls during the first three months after discharge (n = 412). Telephone case monitors assessed current problems, encouraged treatment adherence, provided problem-solving support, and alerted providers to emergent care needs. Patient self-report measures of psychiatric symptoms, substance use, and violence were obtained at intake to residential treatment and 4 months (69% completion rate) and 12 months (64% completion rate) after discharge. Retention was lower than the investigators' planned 70% to 75% rate due to difficulty locating some patients who moved (even their collateral informants did not know where they were) and 45 participants asking to discontinue due to lack of time (n = 10), general dissatisfaction with VA (n = 6), distress during phone calls (n = 5), dissatisfaction with compensation (n = 1), or no specified reason (n = 24). Treatment utilization data was obtained from the VA National Patient Care Database.\n\nIntent-to-treat analyses used mixed modeling to compare clinical outcomes in the telephone monitoring and usual care groups and 4 and 12 months after discharge. Survival analysis was used to compare conditions on time to rehospitalization. Having a slightly smaller-than-intended sample size resulted in modest reductions in statistical power, e.g., power to detect the expected d = .25 effect on PTSD outcomes was reduced from about 90% to 82%, and power to detect the anticipated W = .105 difference in rehospitalization rates was reduced from 88% to 85%. Secondary analyses assessed whether differences in outcomes between the telephone case monitoring and usual care groups were mediated by attending more outpatient visits and completing more medication refills. Exploratory analyses examined whether the effect of telephone support on the clinical outcome measures, number of treatment visits, and medication refills was moderated by number of outpatient mental health visits in the prior year, distance from clinic, treatment expectancies, therapeutic alliance, or co-occurring substance use problems.\n\nStatus: Enrollment, intervention, data collection, and primary analyses are completed. Primary results have been published in Psychiatric Services (Rosen, Tiet, Harris et al., 2013) and two secondary papers have been published in the Journal of Traumatic Stress (Belsher, Tiet, Garvert, \\& Rosen, 2012; Rosen, Adler, \\& Tiet, 2013).\n\nA CDMRP-funded study extending this approach to PTSD outpatients at the Durham, Puget Sound and Palo Alto VA medical centers has recently been completed. Initial results of that second trial suggest that telephone care management improved treatment attendance but had weak effects on outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a PTSD diagnosis entering PTSD residential treatment with an intended length of stay of 15 days or longer (patients in brief evaluation or acute stabilization tracks will not be included, as their discharge plan may include readmission to residential treatment within a few months).\n\nExclusion Criteria:\n\n1. Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);\n2. Active Duty military personnel;\n3. Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;\n4. Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.'}, 'identificationModule': {'nctId': 'NCT00288860', 'acronym': 'TCM-PTSD', 'briefTitle': 'Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Telephone Case Monitoring for Veterans With PTSD', 'orgStudyIdInfo': {'id': 'TEL 03-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephone Monitoring', 'description': 'Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.', 'interventionNames': ['Behavioral: Telephone monitoring', 'Other: Treatment-As-Usual']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-As-Usual', 'description': 'Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.', 'interventionNames': ['Other: Treatment-As-Usual']}], 'interventions': [{'name': 'Telephone monitoring', 'type': 'BEHAVIORAL', 'description': 'Three months of biweekly telephone monitoring and support', 'armGroupLabels': ['Telephone Monitoring']}, {'name': 'Treatment-As-Usual', 'type': 'OTHER', 'description': 'Outpatient mental health Treatment As Usual (psychotherapy and/or medications)', 'armGroupLabels': ['Telephone Monitoring', 'Treatment-As-Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72114-1706', 'city': 'No. Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR'}, {'zip': '49015', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Medical Center, Battle Creek', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'VA Western New York Healthcare System, Buffalo, NY', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '19320', 'city': 'Coatesville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Medical Center, Coatesville', 'geoPoint': {'lat': 39.98316, 'lon': -75.82384}}, {'zip': '98493', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System, Tacoma', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Craig S. Rosen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}