Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT00494650
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2007-06-28', 'studyFirstSubmitQcDate': '2007-06-28', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs', 'timeFrame': 'Measured post-treatment and at 6- and 12-month follow-ups'}, {'measure': 'Depression, anxiety, and other psychiatric symptoms', 'timeFrame': 'Measured post-treatment and at 6- and 12-month follow-ups'}, {'measure': 'PTSD diagnoses and symptom severity', 'timeFrame': 'Measured post-treatment and at 6- and 12-month follow-ups'}], 'secondaryOutcomes': [{'measure': 'Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system', 'timeFrame': 'Measured post-treatment and at 6- and 12-month follow-ups'}, {'measure': 'Quality of life and community functioning', 'timeFrame': 'Measured post-treatment and at 6- and 12-month follow-ups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder', 'Major Depression'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '32368793', 'type': 'DERIVED', 'citation': 'Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.'}, {'pmid': '25858178', 'type': 'DERIVED', 'citation': 'Mueser KT, Gottlieb JD, Xie H, Lu W, Yanos PT, Rosenberg SD, Silverstein SM, Duva SM, Minsky S, Wolfe RS, McHugo GJ. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness. Br J Psychiatry. 2015 Jun;206(6):501-8. doi: 10.1192/bjp.bp.114.147926. Epub 2015 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.', 'detailedDescription': 'Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after experiencing a terrifying event or ordeal in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories about the traumatic event and may experience sleep problems, feel detached or numb, or be easily startled. Studies have shown that PTSD occurs at high rates among people with serious mental illnesses (SMI), such as bipolar disorder, schizophrenia, and major depression. Research has also proven that cognitive behavioral therapy (CBT) is an effective PTSD treatment for caucasians living in rural areas when it is administered by a PhD-level clinician. It is not clear, however, how successful this treatment will be when it is delivered to a minority population by frontline mental health clinicians in an urban setting. This study will evaluate the effectiveness of tailored CBT in treating PTSD in people with additional mental illnesses who live in urban areas of New Jersey.\n\nParticipants in this 4- to 5-month open-label study will be randomly assigned to receive either brief PTSD treatment or CBT. Participants assigned to brief PTSD treatment will have three meetings with a therapist per week. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD. Participants assigned to CBT will attend 12 to 16 counseling sessions per week or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions. Outcomes will be assessed for all participants through interviews that will occur immediately post-treatment, 6 months post-treatment, and 1 year post-treatment.\n\nFor information on a related study, please follow this link:\n\nhttp://clinicaltrials.gov/show/NCT00053690'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets New Jersey definition of severe mental illness (SMI), which includes a DSM-IV diagnosis of an SMI; within the 3 to 6 months prior to study entry, functional limitations in major life activities that would be appropriate for the client's developmental stage; and within 2 years prior to study entry, two or more treatment episodes of greater intensity than outpatient services (such as inpatient, emergency, or partial hospitalization care, or a single episode lasting 3 months or more) OR a normal living situation disrupted to the point that supportive services were required to maintain the patient in their home or residence, or law enforcement officials were required to intervene\n* DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)\n* Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)\n* Speaks English\n\nExclusion Criteria:\n\n* Current diagnosis of alcohol or drug dependence\n* Hospitalization or suicide attempt in the past 2 months"}, 'identificationModule': {'nctId': 'NCT00494650', 'briefTitle': 'Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)', 'orgStudyIdInfo': {'id': 'R01MH064662-02', 'link': 'https://reporter.nih.gov/quickSearch/R01MH064662-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH064662-02', 'link': 'https://reporter.nih.gov/quickSearch/R01MH064662-02', 'type': 'NIH'}, {'id': 'DSIR 83-ATIT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive cognitive behavioral therapy.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive brief PTSD treatment.', 'interventionNames': ['Behavioral: Brief PTSD treatment']}], 'interventions': [{'name': 'Cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'CBT will include 12 to 16 counseling sessions, occurring weekly or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions.', 'armGroupLabels': ['1']}, {'name': 'Brief PTSD treatment', 'type': 'BEHAVIORAL', 'description': 'Brief PTSD treatment will include three weekly meetings with a therapist. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08852', 'city': 'Monmouth Junction', 'state': 'New Jersey', 'country': 'United States', 'facility': 'United Behavioral HealthCare (UBHC): Partial Hospital Program', 'geoPoint': {'lat': 40.379, 'lon': -74.54654}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral HealthCare (UBHC) Extended Treatment', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Kim T. Mueser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}