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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00494650
First received: June 28, 2007
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Post-Traumatic Stress Disorder
 Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Brief PTSD treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • Depression, anxiety, and other psychiatric symptoms [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
  • PTSD diagnoses and symptom severity [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life and community functioning [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: April 2008
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494650

Locations
United States, New Jersey
United Behavioral HealthCare (UBHC): Partial Hospital Program
Monmouth Junction, New Jersey, United States, 08852
University Behavioral HealthCare (UBHC) Extended Treatment
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 Division - Partial Hospital Program
Newark, New Jersey, United States, 07101
University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kim T. Mueser, PhD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00494650     History of Changes
Other Study ID Numbers: R01 MH064662-02, R01MH064662-02, DSIR 83-ATIT
Study First Received: June 28, 2007
Last Updated: August 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
PTSD
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression

Additional relevant MeSH terms:
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders

ClinicalTrials.gov processed this record on May 23, 2013