NCT01542229

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4.7 years

First QC Date

February 17, 2012

Results QC Date

March 1, 2018

Last Update Submit

May 2, 2019

Conditions

Post Traumatic Stress DisorderSchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depression

Keywords

Post Traumatic Stress DisorderSevere Mental Illness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Beck Depression Inventory-II (BDI-II)

    pre to post treatment (12 weeks)

  • Brief Psychiatric Rating Scale-Extended (BPRS-E)

    pre to post treatment (12 weeks)

  • Veterans SF 12 Health Survey (SF-12)

    pre to post treatment (12 weeks)

  • Pittsburgh Seep Quality Index

    pre to post treatment (12 weeks)

Study Arms (2)

Arm 1: PE + TAU

EXPERIMENTAL

Prolonged Exposure Therapy +Treatment As Usual

Behavioral: Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU)

Arm 2: Usual Treatment

ACTIVE COMPARATOR

Treatment As Usual

Behavioral: Treatment As Usual (TAU)

Interventions

Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU)BEHAVIORAL

12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual

Arm 1: PE + TAU
Treatment As Usual (TAU)BEHAVIORAL

Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling

Arm 2: Usual Treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (3)

  • 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.

    PMID: 22884217RESULT

  • 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.

    PMID: 27863313RESULT

  • 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.

    PMID: 26797658RESULT

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, MajorMental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Results Point of Contact

Title
Dr. Anouk L. Grubaugh
Organization
Charleston VAMC
grubaugh@musc.edu
843-789-5853

Study Officials

  • Anouk L Grubaugh, PhD MA BS

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

March 2, 2012

Study Start

May 3, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

July 15, 2019

Results First Posted

July 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)