Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses
2 other identifiers
interventional
200
1 country
5
Brief Summary
This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedAugust 8, 2012
August 1, 2012
4.3 years
June 28, 2007
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Measured post-treatment and at 6- and 12-month follow-ups
Depression, anxiety, and other psychiatric symptoms
Measured post-treatment and at 6- and 12-month follow-ups
PTSD diagnoses and symptom severity
Measured post-treatment and at 6- and 12-month follow-ups
Secondary Outcomes (2)
Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system
Measured post-treatment and at 6- and 12-month follow-ups
Quality of life and community functioning
Measured post-treatment and at 6- and 12-month follow-ups
Study Arms (2)
1
EXPERIMENTALParticipants will receive cognitive behavioral therapy.
2
ACTIVE COMPARATORParticipants will receive brief PTSD treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)
- Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)
- Speaks English
You may not qualify if:
- Current diagnosis of alcohol or drug dependence
- Hospitalization or suicide attempt in the past 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
United Behavioral HealthCare (UBHC): Partial Hospital Program
Monmouth Junction, New Jersey, 08852, United States
University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
New Brunswick, New Jersey, 08901, United States
University Behavioral HealthCare (UBHC) Extended Treatment
New Brunswick, New Jersey, 08901, United States
University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
Newark, New Jersey, 07101, United States
University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program
Newark, New Jersey, 07101, United States
Related Publications (2)
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: 32368793DERIVEDMueser 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.
PMID: 25858178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim T. Mueser, PhD
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
July 2, 2007
Study Start
April 1, 2008
Primary Completion
July 1, 2012
Last Updated
August 8, 2012
Record last verified: 2012-08