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Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses

Not Applicable
Completed
Conditions
Post-Traumatic Stress Disorder
Interventions
Behavioral: Brief PTSD treatment
Behavioral: Cognitive behavioral therapy (CBT)
Registration Number
NCT00494650
Lead Sponsor
Dartmouth-Hitchcock Medical Center
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.

Detailed Description

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.

Participants 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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00053690

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria
  • 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
Exclusion Criteria
  • Current diagnosis of alcohol or drug dependence
  • Hospitalization or suicide attempt in the past 2 months

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2Brief PTSD treatmentParticipants will receive brief PTSD treatment.
1Cognitive behavioral therapy (CBT)Participants will receive cognitive behavioral therapy.
Primary Outcome Measures
NameTimeMethod
Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefsMeasured post-treatment and at 6- and 12-month follow-ups
PTSD diagnoses and symptom severityMeasured post-treatment and at 6- and 12-month follow-ups
Depression, anxiety, and other psychiatric symptomsMeasured post-treatment and at 6- and 12-month follow-ups
Secondary Outcome Measures
NameTimeMethod
Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care systemMeasured post-treatment and at 6- and 12-month follow-ups
Quality of life and community functioningMeasured post-treatment and at 6- and 12-month follow-ups

Trial Locations

Locations (5)

United Behavioral HealthCare (UBHC): Partial Hospital Program

🇺🇸

Monmouth Junction, New Jersey, United States

University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services

🇺🇸

New Brunswick, New Jersey, United States

University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services

🇺🇸

Newark, New Jersey, United States

University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program

🇺🇸

Newark, New Jersey, United States

University Behavioral HealthCare (UBHC) Extended Treatment

🇺🇸

New Brunswick, New Jersey, United States

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