Improving Effectiveness: Treatment Outcome Research

NCT ID: NCT00630578

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Cognitive Processing Therapy

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Processing Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Center for Trauma Recovery, St Louis

OTHER

Sponsor Role lead

Responsible Party

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University of Missouri- St. Louis

Principal Investigators

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Tara Galovski, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Center for Trauma Recovery

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36987703 (View on PubMed)

Other Identifiers

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1R34MH074937-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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