Clinical trial NCT00630578: Improving Effectiveness: Treatment Outcome Research
Official title: Improving Effectiveness: Treatment Outcome Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Posttraumatic Stress Disorder
Physical Assault
Physical Abuse
Sexual Assault
Sexual Abuse
Interpersonal Assault
Cognitive Processing Therapy
Lead sponsor: Center for Trauma Recovery, St Louis
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores
timeFrame: 2 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Center for Trauma Recovery
state: Missouri
Study officials:
affiliation: Center for Trauma Recovery, University of Missouri- St. Louis
name: Tara Galovski, PhD
role: PRINCIPAL_INVESTIGATOR
References: