NCT00371644

Brief Summary

The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

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

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 16, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

August 31, 2006

Results QC Date

November 17, 2014

Last Update Submit

January 6, 2015

Conditions

Keywords

Stress Disorders, Post-TraumaticCognitive Processing TherapyMilitary sexual traumaPsychology, MilitaryVeteransRapeVeterans, psychologyHealthcare utilization

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist (PCL)

    The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.

    Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).

Behavioral: Cognitive Processing Therapy

Arm 2

ACTIVE COMPARATOR

Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).

Behavioral: Present-Centered Therapy

Interventions

CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.

Also known as: CPT
Arm 1

PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.

Also known as: PCT
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
  • Experienced MST no less than 3 months prior to entering the trial
  • Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
  • Have at least one clear memory of the trauma (sufficient to write impact statement)
  • Consent to be randomized into treatment
  • Not receive other psychotherapy during the 6 weeks of active treatment
  • (if on psychoactive medications) if new antidepressant, be on stable medication regimen for a minimum of 6 weeks prior to entering the trial (if recent changes to antidepressant dosage or additions or changes of antipsychotic or anti-anxiety medication, eligible immediately)

You may not qualify if:

  • Current substance dependence
  • Prior substance dependence that has not been in remission for at least 3 months
  • Any current psychotic symptoms
  • Current mania or unstable Bipolar Disorder
  • Prominent current suicidal or homicidal features
  • Any severe cognitive impairment or history of Organic Mental Disorder
  • Current involvement in a violent relationship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Related Publications (9)

  • Suris A, Link-Malcolm J, Chard K, Ahn C, North C. A randomized clinical trial of cognitive processing therapy for veterans with PTSD related to military sexual trauma. J Trauma Stress. 2013 Feb;26(1):28-37. doi: 10.1002/jts.21765. Epub 2013 Jan 16.

  • Holliday R, Link-Malcolm J, Morris EE, Suris A. Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. Mil Med. 2014 Oct;179(10):1077-82. doi: 10.7205/MILMED-D-13-00309.

  • Mullen K, Holliday R, Morris E, Raja A, Suris A. Cognitive processing therapy for male veterans with military sexual trauma-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):761-4. doi: 10.1016/j.janxdis.2014.09.004. Epub 2014 Sep 21.

  • O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  • Holliday R, Holder N, Monteith LL, Suris A. Decreases in Suicide Cognitions After Cognitive Processing Therapy Among Veterans With Posttraumatic Stress Disorder Due to Military Sexual Trauma: A Preliminary Examination. J Nerv Ment Dis. 2018 Jul;206(7):575-578. doi: 10.1097/NMD.0000000000000840.

  • Wiblin J, Holder N, Holliday R, Suris A. Predictors of Unbearability, Unlovability, and Unsolvability in Veterans With Military-Sexual-Trauma-Related Posttraumatic Stress Disorder. J Interpers Violence. 2021 Apr;36(7-8):3814-3830. doi: 10.1177/0886260518777554. Epub 2018 May 31.

  • Holliday R, Holder N, Suris A. Reductions in self-blame cognitions predict PTSD improvements with cognitive processing therapy for military sexual trauma-related PTSD. Psychiatry Res. 2018 May;263:181-184. doi: 10.1016/j.psychres.2018.03.007. Epub 2018 Mar 14.

  • Holliday RP, Holder ND, Williamson MLC, Suris A. Therapeutic response to Cognitive Processing Therapy in White and Black female veterans with military sexual trauma-related PTSD. Cogn Behav Ther. 2017 Sep;46(5):432-446. doi: 10.1080/16506073.2017.1312511. Epub 2017 May 9.

  • Williams R, Holliday R, Clem M, Anderson E, Morris EE, Suris A. Borderline Personality Disorder and Military Sexual Trauma: Analysis of Previous Traumatization and Current Psychiatric Presentation. J Interpers Violence. 2017 Aug;32(15):2223-2236. doi: 10.1177/0886260515596149. Epub 2015 Jul 21.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersMilitary Sexual Trauma

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorSexual Trauma

Results Point of Contact

Title
Dr. Alina Suris
Organization
VA North Texas Health Care System

Study Officials

  • Alina M Suris, PhD

    VA North Texas Health Care System, Dallas

    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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

February 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

January 15, 2015

Results First Posted

December 16, 2014

Record last verified: 2015-01

Locations