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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Brief PTSD treatment
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • United Behavioral HealthCare (UBHC): Partial Hospital Program
  • University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
  • University Behavioral HealthCare (UBHC) Extended Treatment
  • University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
  • University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive cognitive behavioral therapy.

Participants will receive brief PTSD treatment.

Outcomes

Primary Outcome Measures

Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Depression, anxiety, and other psychiatric symptoms
PTSD diagnoses and symptom severity

Secondary Outcome Measures

Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system
Quality of life and community functioning

Full Information

First Posted
June 28, 2007
Last Updated
August 7, 2012
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00494650
Brief Title
Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses
Official Title
Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive brief PTSD treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief PTSD treatment
Intervention Description
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 Outcome Measure Information:
Title
Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Time Frame
Measured post-treatment and at 6- and 12-month follow-ups
Title
Depression, anxiety, and other psychiatric symptoms
Time Frame
Measured post-treatment and at 6- and 12-month follow-ups
Title
PTSD diagnoses and symptom severity
Time Frame
Measured post-treatment and at 6- and 12-month follow-ups
Secondary Outcome Measure Information:
Title
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
Title
Quality of life and community functioning
Time Frame
Measured post-treatment and at 6- and 12-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim T. Mueser, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Behavioral HealthCare (UBHC): Partial Hospital Program
City
Monmouth Junction
State/Province
New Jersey
ZIP/Postal Code
08852
Country
United States
Facility Name
University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University Behavioral HealthCare (UBHC) Extended Treatment
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32368793
Citation
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
Results Reference
derived
PubMed Identifier
25858178
Citation
Mueser KT, Gottlieb JD, Xie H, Lu W, Yanos PT, Rosenberg SD, Silverstein SM, Duva SM, Minsky S, Wolfe RS, McHugo GJ. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness. Br J Psychiatry. 2015 Jun;206(6):501-8. doi: 10.1192/bjp.bp.114.147926. Epub 2015 Apr 9.
Results Reference
derived

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

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