Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder

September 24, 2012 updated by: Willi Butollo, Ludwig-Maximilians - University of Munich

Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy

This study aims to compare two active psychological treatments for PTSD. One is an established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies to perform on a similar level, which would constitute evidence for the efficacy of DET.

Study Overview

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Munich, Germany, 80802
        • LS für Klinische Psychologie und Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • main diagnosis of posttraumatic stress disorder
  • time since trauma is at least three months

Exclusion Criteria:

  • acute suicidal ideation
  • severe personality pathology
  • substance dependence
  • early childhood trauma (e.g. child sexual abuse)
  • history of psychosis
  • dissociative identity disorder
  • neurological impairment (e.g. craniocerebral injury with functional impairment)
  • severe pre-traumatic depression
  • ongoing psychotherapy
  • lack of motivation
  • lack of German language skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dialogical exposure therapy
Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.
This 24-session treatment protocol includes cognitive-behavioral components integrated with a frame based on gestalt principles. There are four phases, safety, stabilization, confrontation and integration.
ACTIVE_COMPARATOR: Cognitive Processing Therapy
Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993.
This is a German adaptation of Cognitive Processing Therapy, developed by Prof. P. A. Resick. This intervention includes cognitive restructuring, a focus on the traumatic memory and a focus on issues that are likely to be problematic in traumatized individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTBS Symptom Severity
Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Even though participants are assessed by a clinical interview before entering the study, the primary outcome measure is the PDS which is applied before and after treatment as well as at 6-month follow-up.
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptom change (IES-R)
Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment). Also measured at each session (up to 24 time points between pre- and posttreatment).
The IES-R is a short instrument for the measurement of PTSD symptom severity. In this study, the IES-R is applied before every session in order to measure symptom change over the time of the therapy.
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment). Also measured at each session (up to 24 time points between pre- and posttreatment).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory
Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
The Brief Symptom Inventory (BSI) is a measure of general psychological distress.
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Inventory of Interpersonal Problems (IIP)
Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
The IIP is a widely used instrument to measure interpersonal distress.
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Willi Butollo, Prof., Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (ESTIMATE)

September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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