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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dialogical exposure therapy
Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.
Behavioral: Dialogical exposure therapy
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.
Behavioral: Cognitive Processing Therapy (German Adaptation)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gestalt therapy for PTSD

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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