NCT00032617

Brief Summary

The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy. The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2002

Typical duration for phase_3

Geographic Reach
1 country

13 active sites

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

March 27, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2002

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

3.7 years

First QC Date

March 27, 2002

Last Update Submit

September 22, 2010

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSDStress DisorderTrauma

Outcome Measures

Primary Outcomes (1)

  • summing totals of 17 DSM-IV symptoms

    10 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Prolonged Exposure

Procedure: Prolonged Exposure

2

ACTIVE COMPARATOR

Present Centered Therapy

Procedure: Present Centered Therapy

Interventions

Prolonged ExposurePROCEDURE

trauma-focused exposure therapy

1
Present Centered TherapyPROCEDURE

therapy that focuses on current problems

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female veterans or active duty personnel with a current diagnosis of PTSD due to any type of trauma;
  • have experienced trauma no less than 3 months prior to entering the trial;
  • have at least one clear memory of the trauma that caused their PTSD (sufficient for constructing a scene to be used in PE);
  • consent to be randomized into treatment;
  • not receive other psychotherapy for PTSD during the 10 weeks of active treatment;
  • psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed;
  • if on psychoactive medication be on a stable medication regimen for a minimum of 2 months prior to entering the trial.

You may not qualify if:

  • current substance dependence;
  • prior substance dependence that has not been in remission at least 3 months;
  • any current psychotic symptoms; current Mania or Bipolar Disorder;
  • prominent current suicidal or homicidal ideation;
  • any severe cognitive impairment or history of Organic Mental Disorder;
  • current involvement in a violent relationship;
  • self-mutilation within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Medical Center, Bay Pines

Bay Pines, Florida, 33708, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Southeast Veterans Healthcare System, New Orleans

New Orleans, Louisiana, 70112, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Walter Reed (DCI-HUC)

Bethesda, Maryland, 20814, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

VA Medical Center, Cincinnati

Cincinnati, Ohio, 45220, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

VA Medical & Regional Office Center

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (6)

  • Stirman SW, Cohen ZD, Lunney CA, DeRubeis RJ, Wiley JF, Schnurr PP. A personalized index to inform selection of a trauma-focused or non-trauma-focused treatment for PTSD. Behav Res Ther. 2021 Jul;142:103872. doi: 10.1016/j.brat.2021.103872. Epub 2021 Apr 26.

    PMID: 34051626DERIVED

  • Schnurr PP, Lunney CA. Residual symptoms following prolonged exposure and present-centered therapy for PTSD in female veterans and soldiers. Depress Anxiety. 2019 Feb;36(2):162-169. doi: 10.1002/da.22871. Epub 2018 Dec 21.

    PMID: 30576030DERIVED

  • Lunney CA, Schnurr PP, Cook JM. Comparison of clinician- and self-assessments of posttraumatic stress symptoms in older versus younger veterans. J Trauma Stress. 2014 Apr;27(2):144-51. doi: 10.1002/jts.21908. Epub 2014 Apr 2.

    PMID: 24700623DERIVED

  • Rosen CS, Greenbaum MA, Schnurr PP, Holmes TH, Brennan PL, Friedman MJ. Do benzodiazepines reduce the effectiveness of exposure therapy for posttraumatic stress disorder? J Clin Psychiatry. 2013 Dec;74(12):1241-8. doi: 10.4088/JCP.13m08592.

    PMID: 24434093DERIVED

  • Wolf EJ, Lunney CA, Miller MW, Resick PA, Friedman MJ, Schnurr PP. The dissociative subtype of PTSD: a replication and extension. Depress Anxiety. 2012 Aug;29(8):679-88. doi: 10.1002/da.21946. Epub 2012 May 25.

    PMID: 22639402DERIVED

  • Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.

    PMID: 17327524DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Matthew J. Friedman, MD PhD

    VA Medical & Regional Office Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

March 27, 2002

First Posted

March 28, 2002

Study Start

August 1, 2002

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

US(13)