PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness) (PTSD/SMI)

Improving PTSD Service Delivery for Veterans With Severe Mental Illness

As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among Veterans and this symptom presentation clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated that these data will establish a much needed clinical course of action for what is considered a vulnerable yet highly underserved patient population.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depression; Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU); Behavioral: Treatment As Usual (TAU)

Detailed Description

The overarching aim of this proposal is to compare the efficacy of Prolonged Exposure for posttraumatic stress disorder (PTSD) plus treatment as usual (PE+TAU) relative to treatment as usual (TAU) alone using a randomized, between groups, repeated measures design. One hundred fifty six (156) ethnically/racially diverse male and female Veterans with posttraumatic stress disorder (PTSD) and severe mental illness (SMI) will be recruited from the Charleston VA and affiliated Community Based Outpatient Clinics (CBOCs) during the study time frame. For the investigators' study purposes, severe mental illness (SMI) is defined as (1) the presence of a past year Diagnostic Statistical Manual (DSM-IV) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or severe depression (2) resulting in persistent impairment in self-care, work, or social functioning. Veterans will be randomized 1:1 to one of two conditions: PE+TAU or TAU. The active intervention phase is 12 weeks. Veterans randomized to treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling and Veterans randomized to prolonged exposure (PE) plus treatment as usual (TAU) will receive 12 weekly sessions of prolonged exposure (PE) in addition to treatment as usual (TAU). All participants will be assessed at baseline, 6 weeks, post-treatment, and at 3 and 6 months. Additionally, they will complete two self report forms during sessions 3, 6, and 9.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Posttraumatic Stress Disorder (PTSD) on the Clinician Administered PTSD Scale (CAPS; Blake et al., 1990);
• A confirmed diagnosis of a psychotic disorder, bipolar disorder, or severe unipolar depression on the Mini Neuropsychiatric Interview (MINI; Sheehan et al., 1998).

Exclusion Criteria:

• Having a household member who is already enrolled in the study;
• Active psychosis, mania, or dementia at screening;
• Suicidal ideation with clear intent;
• Current substance dependence; and
• Concurrent enrollment in another clinical trial for PTSD or depression.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1: PE + TAU; Prolonged Exposure Therapy +Treatment As Usual	Behavioral: Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU); 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual
ACTIVE_COMPARATOR: Arm 2: Usual Treatment; Treatment As Usual	Behavioral: Treatment As Usual (TAU); Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Stress Disorder (PTSD) Checklist (PCL)	The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL were used, and total scores range from 17 to 85 with higher scores indicative of greater PTSD severity.	pre to post treatment (12 weeks)
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)	The Clinician Administered PTSD (Posttraumatic Stress Disorder; PTSD) Scale (CAPS) is a 30-item structured interview that corresponds to DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assess symptoms over the past week/month. The CAPS was used to measure current PTSD (yes/no diagnosis) as well as total PTSD severity (scores range 0-136, with higher scores indicative of more severe PTSD).	pre to post treatment (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory-II (BDI-II)	The Beck Depression Inventory-II is a 21 item measure of depressive severity. Total BDI-II scores were used. Scores on the BDI-II range from 0 to 63 with higher scores indicative of greater symptom severity.	pre to post treatment (12 weeks)
Brief Psychiatric Rating Scale-Extended (BPRS-E)	The Brief Psychiatric Rating Scale-Extended (BPRS-E) is a 24 item measure of psychopathology across several dimensions (i.e., delusions, motor hyperactivity, withdrawal and blunted affect, self-neglect, etc.) and is a commonly used measure for severely and persistently ill patient populations. Total BPRS scores were used and can range from 24 (score of 1 on all items, symptom not present) to 168 (score of 7 on all items, extremely severe).	pre to post treatment (12 weeks)
Veterans SF 12 Health Survey (SF-12)	The Veterans SF 12 Health Survey (SF-12) is a valid and reliable instrument to measure quality of life and/or functional status in Veterans. The SF-12 was used to track changes in general mental [MCS mental component score) and physical health (PCS physical component score) functioning. Scores on the SF-12 scales range from 0 to 100 once converted and higher scores are indicative of better mental and physical health. The MCS score was used in the current analyses.	pre to post treatment (12 weeks)
Pittsburgh Seep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with ratings of 5 or higher indicative of poor sleep quality. Item 9, assessing overall quality of sleep, was used in current analyses. Scores on this item range from 0 to 3, with higher scores indicative of worse sleep quality.	pre to post treatment (12 weeks)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Anouk L Grubaugh, PhD MA BS, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

General Publications

• Grubaugh AL, Tuerk PW, Egede LE, Frueh BC. Perceptions of PTSD research participation among patients with severe mental illness. Psychiatry Res. 2012 Dec 30;200(2-3):1071-3. doi: 10.1016/j.psychres.2012.07.039. Epub 2012 Aug 9.
• Brown WJ, Wilkerson AK, Milanak ME, Tuerk PW, Uhde TW, Cortese BM, Grubaugh AL. An examination of sleep quality in veterans with a dual diagnosis of PTSD and severe mental illness. Psychiatry Res. 2017 Jan;247:15-20. doi: 10.1016/j.psychres.2016.07.062. Epub 2016 Sep 30.
• Grubaugh AL, Clapp JD, Frueh BC, Tuerk PW, Knapp RG, Egede LE. Open trial of exposure therapy for PTSD among patients with severe and persistent mental illness. Behav Res Ther. 2016 Mar;78:1-12. doi: 10.1016/j.brat.2015.12.006. Epub 2015 Dec 28.

Helpful Links

• pubmed
• pubmed
• pubmed

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2012
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (ESTIMATE): March 2, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Post Traumatic Stress Disorder; Severe Mental Illness
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: IIR 11-306; Pro00013928 (OTHER: Medical University of South Carolina IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No