NCT00630578

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

3.4 years

First QC Date

February 28, 2008

Last Update Submit

April 6, 2011

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDPosttraumatic Stress DisorderPhysical AssaultPhysical AbuseSexual AssaultSexual AbuseInterpersonal AssaultCognitive Processing Therapy

Outcome Measures

Primary Outcomes (1)

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

    2 weeks post-treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Cognitive Processing Therapy

Behavioral: Cognitive Processing Therapy

2

NO INTERVENTION

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

Interventions

Cognitive Processing TherapyBEHAVIORAL

Clients will receive between 4 and 20 sessions of Cognitive Processing Therapy.

12

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Trauma Recovery

St Louis, Missouri, 63121, United States

Location

Related Publications (1)

  • Alpert E, Carpenter JK, Smith BN, Woolley MG, Raterman C, Farmer CC, Kehle-Forbes SM, Galovski TE. Leveraging observational data to identify in-session patient and therapist predictors of cognitive processing therapy response and completion. J Trauma Stress. 2023 Apr;36(2):397-408. doi: 10.1002/jts.22924. Epub 2023 Mar 29.

    PMID: 36987703DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Tara Galovski, PhD

    Center for Trauma Recovery, University of Missouri- St. Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

US(1)