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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494650
• Other study ID #: R01MH064662-02
• Secondary ID: R01MH064662-02DS
• Status: Completed
• Phase: N/A
• First received: June 28, 2007
• Last updated: August 7, 2012
• Start date: April 2008

Study information

• Verified date: August 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	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	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

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs		Measured post-treatment and at 6- and 12-month follow-ups	No
Primary	Depression, anxiety, and other psychiatric symptoms		Measured post-treatment and at 6- and 12-month follow-ups	No
Primary	PTSD diagnoses and symptom severity		Measured post-treatment and at 6- and 12-month follow-ups	No
Secondary	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	No
Secondary	Quality of life and community functioning		Measured post-treatment and at 6- and 12-month follow-ups	No