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Improving Effectiveness: Treatment Outcome Research

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Sponsored by
Center for Trauma Recovery, St Louis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Posttraumatic Stress Disorder, Physical Assault, Physical Abuse, Sexual Assault, Sexual Abuse, Interpersonal Assault, Cognitive Processing Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Trauma Recovery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Cognitive Processing Therapy

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.

Outcomes

Primary Outcome Measures

Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores

Secondary Outcome Measures

Full Information

First Posted
February 28, 2008
Last Updated
April 6, 2011
Sponsor
Center for Trauma Recovery, St Louis
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00630578
Brief Title
Improving Effectiveness: Treatment Outcome Research
Official Title
Improving Effectiveness: Treatment Outcome Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center for Trauma Recovery, St Louis
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Posttraumatic Stress Disorder, Physical Assault, Physical Abuse, Sexual Assault, Sexual Abuse, Interpersonal Assault, Cognitive Processing Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cognitive Processing Therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Description
Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.
Primary Outcome Measure Information:
Title
Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores
Time Frame
2 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Galovski, PhD
Organizational Affiliation
Center for Trauma Recovery, University of Missouri- St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Trauma Recovery
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States

12. IPD Sharing Statement

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Improving Effectiveness: Treatment Outcome Research

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