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Stress Disorders, Post-TraumaticPhase 3NCT00032617

A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women

A Phase 3 study testing Prolonged Exposure and Present Centered Therapy in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
Prolonged Exposure and Present Centered Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
13 sitesUnited States
Study dates
Aug 2002to Apr 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • New Mexico VA Health Care System, Albuquerque

    Albuquerque, New Mexico, 87108-5153

  • VA Maryland Health Care System, Baltimore

    Baltimore, Maryland, 21201

  • VA Medical Center, Bay Pines

    Bay Pines, Florida, 33708

  • Walter Reed (DCI-HUC)

    Bethesda, Maryland, 20814

  • VA Medical Center, Jamaica Plain Campus

    Boston, Massachusetts, 02130

  • VA Medical Center, Cincinnati

    Cincinnati, Ohio, 45220

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106

  • VA North Texas Health Care System, Dallas

    Dallas, Texas, 75216

  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

  • VA Eastern Colorado Health Care System, Denver

    Denver, Colorado, 80220

  • Southeast Veterans Healthcare System, New Orleans

    New Orleans, Louisiana, 70112

  • VA Medical Center, Portland

    Portland, Oregon, 97201

  • VA Medical & Regional Office Center

    White River Junction, Vermont, 05009-0001

Other trials in United States

About this study

Official title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)

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.

Read the detailed description

Intervention: Patients will be randomized to one of two interventions: Prolonged Exposure (PE) consisting of 10 weekly treatment sessions that include education about and exposure to the memories of the trauma to which the patient was engaged; or Present Center Therapy (PCT), which will consist of a control therapy of the same duration that will provide emotional support for the trauma victim.

Primary Hypothesis: Prolonged Exposure (PE) will be more effective than Present-Centered Therapy (PCT) for the treatment of PTSD due to military-related trauma in women veterans. PE specifically targets PTSD symptoms, and the CAPS, our primary outcome measure. The Clinician Administered PTSD Scale (CAPS) is considered to be the gold-standard for PTSD assessment.

Secondary Hypothesis: PE will be more effective than PCT for treating the anxiety and depression that often are comorbid with PTSD.

Study Abstract: As noted in a recent report on the VA Women's Health Project, it is important to study women veterans because they are increasingly seeking VA health care. For many women veterans, Posttraumatic Stress Disorder (PTSD) is a specific healthcare concern that is associated with substantial psychosocial and functional disability.

The study was proposed in response to the Research Priority Announcement on Posttraumatic Stress Disorder research issued August 1, 1997, as a study aimed a special subpopulation of VA patients with PTSD: women veterans who have been traumatized during their military service.

The first planning meeting for the study was held January 20-21, 2000 in Washington, DC. The protocol was submitted on August 1, 2000; it was reviewed and approved by the Cooperative Studies Evaluation Committee on October 10, 2000. Intake of training cases is expected to begin 01/01/2002.

Being tested
Prolonged Exposure, Present Centered Therapy
Keywords
PTSD, Stress Disorder, Trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged ExposureProcedure or surgery

    trauma-focused exposure therapy

  • Present Centered TherapyProcedure or surgery

    therapy that focuses on current problems

Study groups in NCT00032617
Study groupRoleWhat they receive
1Active comparatorProlonged Exposure
Receives: Procedure: Prolonged Exposure
2Active comparatorPresent Centered Therapy
Receives: Procedure: Present Centered Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. summing totals of 17 DSM-IV symptoms

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2002 (estimated)
  2. Study startAug 2002
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00032617
Sponsor's protocol ID
494
Status last verified
Sep 2010
First submitted
27 Mar 2002
Last updated
24 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34051626

  • 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.

    PubMed 30576030

  • 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.

    PubMed 24700623

  • 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.

    PubMed 24434093

  • 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.

    PubMed 22639402

  • 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.

    PubMed 17327524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prolonged Exposure and Present Centered Therapy in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

summing totals of 17 DSM-IV symptoms (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00032617, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.

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