Improving Effectiveness: Treatment Outcome Research

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Center for Trauma Recovery, St Louis
ClinicalTrials.gov Identifier:
NCT00630578
First received: February 28, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

This proposal seeks to increase the effectiveness of an existing treatment strategy, cognitive processing therapy (CPT), for the remediation of Posttraumatic Stress Disorder among crime victims by varying the duration and content of the intervention in accordance with participants' needs. A secondary goal is to identify predictors of duration of treatment necessary to achieve good end state functioning, including individual and trauma variables, cognitive and emotional variables, and Axis II pathology. Finally, by including a sample of male participants, the generalizability of CPT will be tested. It is anticipated that these modifications will speed the dissemination of CPT to community practice thus benefiting more trauma victims. Fifty subjects will be randomly assigned to either the modified CPT condition or to a symptom-monitoring, minimal attention condition designed to control for the effects of the daily monitoring and the passage of time. Utilizing a semicrossover design, the control condition will be crossed over to the active treatment, allowing for a replication within the study. The entire treated sample (N = 50) will be compared to a sample (N = 50) receiving strict 12-session protocol-driven CPT through the course of a recent study conducted at the same site using the same primary outcome measures. Conducting the proposed study will have important implications on advancing the ecological validity and effectiveness of applied research on PTSD.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Cognitive Processing Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Effectiveness: Treatment Outcome Research

Resource links provided by NLM:


Further study details as provided by Center for Trauma Recovery, St Louis:

Primary Outcome Measures:
  • Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores [ Time Frame: 2 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cognitive Processing Therapy
Behavioral: Cognitive Processing Therapy
Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
No Intervention: 2
Arm 2 participants will monitor their symptoms for a period of 10 weeks, prior to being crossed over into active treatment. This will allow investigators to account for the passage of time without intervention when tracking symptoms.
Behavioral: Cognitive Processing Therapy
Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be survivors of interpersonal assault, who are at least three months post-crime at the time of their participation and who meet criteria for a diagnosis of PTSD. There is no upper time limit on time since crime for participation.

Exclusion Criteria:

  • Exclusion criteria for participants include psychosis, mental retardation, active suicidality, parasuicidality, or current addiction to drugs or alcohol. In the case of apparent illiteracy, we will try to accommodate the individual as much as possible to maximize success in the program. In addition, participants cannot be in a currently abusive relationship or being stalked. For marital rape or domestic violence, the participant must have been out of the relationship for at least three months. Participants may continue the use of any medications throughout the study. However, participants must be willing to keep the medication usage stable for the duration of the study and must be stabilized on any new medication for one month prior to initial assessment. Participants will sign a contract to this effect. All medication use will be tracked throughout the course of the study on the daily symptom monitoring diaries, including over the counter medications. Finally, participants can have received any therapy in the past with the exception of CPT. They may be receiving concurrent therapy as long as it is not trauma-focused. Allowing subjects to continue with concurrent therapy offers them the option to continue with established supports and more closely mimics clinical practice and the generalizability of the results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630578

Locations
United States, Missouri
Center for Trauma Recovery
St. Louis, Missouri, United States, 63121
Sponsors and Collaborators
Center for Trauma Recovery, St Louis
Investigators
Principal Investigator: Tara Galovski, PhD Center for Trauma Recovery, University of Missouri- St. Louis
  More Information

No publications provided

Responsible Party: Tara Galovski, University of Missouri- St. Louis
ClinicalTrials.gov Identifier: NCT00630578     History of Changes
Other Study ID Numbers: 1R34MH074937-01A2
Study First Received: February 28, 2008
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Trauma Recovery, St Louis:
PTSD
Posttraumatic Stress Disorder
Physical Assault
Physical Abuse
Sexual Assault
Sexual Abuse
Interpersonal Assault
Cognitive Processing Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014