Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-01 @ 5:32 PM
Study NCT ID:
NCT00988104
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structured Clinical Interview for DSM IV: Mood and PTSD modules', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}], 'secondaryOutcomes': [{'measure': 'Davidson Trauma Scale', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}, {'measure': 'Patient Health Questionnaire - 9 (depression)', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}, {'measure': 'Post Traumatic Growth Inventory', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}, {'measure': 'McGill pain Questionnaire', 'timeFrame': '1 week, 1 month and 6 months post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavior Therapy', 'Randomized Controlled Trial'], 'conditions': ['Stress Disorders, Post-Traumatic', 'Mood Disorders', 'Sleep Disorders']}, 'referencesModule': {'references': [{'pmid': '18182894', 'type': 'BACKGROUND', 'citation': 'McKibben JB, Bresnick MG, Wiechman Askay SA, Fauerbach JA. Acute stress disorder and posttraumatic stress disorder: a prospective study of prevalence, course, and predictors in a sample with major burn injuries. J Burn Care Res. 2008 Jan-Feb;29(1):22-35. doi: 10.1097/BCR.0b013e31815f59c4.'}, {'pmid': '17585064', 'type': 'BACKGROUND', 'citation': 'Fauerbach JA, McKibben J, Bienvenu OJ, Magyar-Russell G, Smith MT, Holavanahalli R, Patterson DR, Wiechman SA, Blakeney P, Lezotte D. Psychological distress after major burn injury. Psychosom Med. 2007 Jun;69(5):473-82. doi: 10.1097/psy.0b013e31806bf393.'}, {'pmid': '18362052', 'type': 'BACKGROUND', 'citation': 'Smith MT, Klick B, Kozachik S, Edwards RE, Holavanahalli R, Wiechman S, Blakeney P, Lezotte D, Fauerbach JA. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008 Sep 15;138(3):497-506. doi: 10.1016/j.pain.2008.01.028. Epub 2008 Mar 24.'}, {'pmid': '18036980', 'type': 'BACKGROUND', 'citation': 'Edwards RR, Magyar-Russell G, Thombs B, Smith MT, Holavanahalli RK, Patterson DR, Blakeney P, Lezotte DC, Haythornthwaite JA, Fauerbach JA. Acute pain at discharge from hospitalization is a prospective predictor of long-term suicidal ideation after burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S36-42. doi: 10.1016/j.apmr.2007.05.031.'}, {'pmid': '18020941', 'type': 'BACKGROUND', 'citation': 'Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.'}, {'pmid': '16554686', 'type': 'BACKGROUND', 'citation': 'Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.'}, {'pmid': '15640730', 'type': 'BACKGROUND', 'citation': 'Fauerbach JA, Lezotte D, Hills RA, Cromes GF, Kowalske K, de Lateur BJ, Goodwin CW, Blakeney P, Herndon DN, Wiechman SA, Engrav LH, Patterson DR. Burden of burn: a norm-based inquiry into the influence of burn size and distress on recovery of physical and psychosocial function. J Burn Care Rehabil. 2005 Jan-Feb;26(1):21-32. doi: 10.1097/01.bcr.0000150216.87940.ac.'}, {'pmid': '12543997', 'type': 'BACKGROUND', 'citation': 'Lawrence JW, Fauerbach JA. Personality, coping, chronic stress, social support and PTSD symptoms among adult burn survivors: a path analysis. J Burn Care Rehabil. 2003 Jan-Feb;24(1):63-72; discussion 62. doi: 10.1097/00004630-200301000-00016.'}, {'pmid': '12142577', 'type': 'BACKGROUND', 'citation': 'Fauerbach JA, Richter L, Lawrence JW. Regulating acute posttrauma distress. J Burn Care Rehabil. 2002 Jul-Aug;23(4):249-57. doi: 10.1097/00004630-200207000-00005.'}, {'pmid': '19170120', 'type': 'BACKGROUND', 'citation': 'Fauerbach JA, Lawrence JW, Fogel J, Richter L, Magyar-Russell G, McKibben JB, McCann U. Approach-avoidance coping conflict in a sample of burn patients at risk for posttraumatic stress disorder. Depress Anxiety. 2009;26(9):838-50. doi: 10.1002/da.20439.'}], 'seeAlsoLinks': [{'url': 'http://www.hopkinsmedicine.org/burn/index.html', 'label': 'Johns Hopkins Burn Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.', 'detailedDescription': 'Importance: Burns are painful, life threatening and disfiguring. Severe psychological distress, pain and sleep disturbance are among the most common, enduring and disabling of secondary complications, however, no evidence based treatments exists for these complex problems in the acute burn care setting.\n\nDesign: Randomized, controlled effectiveness trial, group assignment blinded to baseline status, groups stratified by history of pre-existing psychiatric disorder.\n\nObjectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART) protocol; To evaluate its short and long-term effectiveness, relative to viable placebo, Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD), mediators, and, enhancing health and function outcomes.\n\nSetting: A leading edge, State-dedicated, regional burn center in a major, metropolitan teaching hospital serving diverse residents from large urban settings, small towns and remote rural areas.\n\nInterventions: SMART (focused cognitive-behavioral therapy with training in anxiety management, and treatment with prolonged exposure and cognitive restructuring) will be contrasted with SC (non-directive empathy, warmth, positive regard).\n\nPrimary Outcome Measures: Health (psychological distress, sleep, pain), function (physical, psychological, social), costs (direct and indirect).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 70 years old\n* acute burn injury\n* exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).\n\nExclusion Criteria:\n\n* Age less than 18 or greater than 70 years\n* Presence of a significant cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality)\n* Inability to communicate in English\n* intubated or sedated'}, 'identificationModule': {'nctId': 'NCT00988104', 'acronym': 'SMART', 'briefTitle': 'Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)', 'orgStudyIdInfo': {'id': 'NA_00002545'}, 'secondaryIdInfos': [{'id': 'NIDRR H133A070045'}, {'id': 'H133A070045', 'type': 'OTHER_GRANT', 'domain': 'NIDILRR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Counseling', 'interventionNames': ['Behavioral: Supportive Counseling']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['SMART'], 'description': 'CBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques.', 'armGroupLabels': ['Cognitive Behavioral Therapy']}, {'name': 'Supportive Counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Usual Care'], 'description': 'Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)', 'armGroupLabels': ['Supportive Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Burn Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'James A Fauerbach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Una D McCann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}