Skip to main content
OpenTrials
Completed

NCT Number: NCT00494650

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Behavioral HealthCare (UBHC): Partial Hospital Program, Monmouth Junction, New Jersey, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs

    Time frame: Measured post-treatment and at 6- and 12-month follow-ups

  2. Depression, anxiety, and other psychiatric symptoms

    Time frame: Measured post-treatment and at 6- and 12-month follow-ups

  3. PTSD diagnoses and symptom severity

    Time frame: Measured post-treatment and at 6- and 12-month follow-ups

Secondary outcomes

  1. 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

  2. Quality of life and community functioning

    Time frame: Measured post-treatment and at 6- and 12-month follow-ups

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
First posted
Jul 2, 2007
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.