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

August 7, 2012 updated by: Dartmouth-Hitchcock Medical Center

Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)

This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Monmouth Junction, New Jersey, United States, 08852
        • United Behavioral HealthCare (UBHC): Partial Hospital Program
      • New Brunswick, New Jersey, United States, 08901
        • University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
      • New Brunswick, New Jersey, United States, 08901
        • University Behavioral HealthCare (UBHC) Extended Treatment
      • Newark, New Jersey, United States, 07101
        • University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
      • Newark, New Jersey, United States, 07101
        • University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive cognitive behavioral therapy.
Behavioral: Cognitive behavioral therapy (CBT)
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.
Active Comparator: 2
Participants will receive brief PTSD treatment.
Behavioral: Brief PTSD treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Time Frame: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
Depression, anxiety, and other psychiatric symptoms
Time Frame: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
PTSD diagnoses and symptom severity
Time Frame: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system
Time Frame: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
Quality of life and community functioning
Time Frame: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Kim T. Mueser, PhD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

July 2, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH064662-02 (U.S. NIH Grant/Contract)
  • DSIR 83-ATIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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