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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dialogical exposure therapy
Cognitive Processing Therapy (German Adaptation)
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, PTSD, psychotherapy, randomized trial, gestalt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LS für Klinische Psychologie und Psychotherapie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialogical exposure therapy

Cognitive Processing Therapy

Arm Description

Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.

Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993.

Outcomes

Primary Outcome Measures

PTBS Symptom Severity
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.

Secondary Outcome Measures

PTSD Symptom change (IES-R)
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.

Full Information

First Posted
September 18, 2012
Last Updated
September 24, 2012
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01693497
Brief Title
Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder
Official Title
Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, PTSD, psychotherapy, randomized trial, gestalt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialogical exposure therapy
Arm Type
Experimental
Arm Description
Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.
Arm Title
Cognitive Processing Therapy
Arm Type
Active Comparator
Arm Description
Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993.
Intervention Type
Behavioral
Intervention Name(s)
Dialogical exposure therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (German Adaptation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTBS Symptom Severity
Description
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.
Time Frame
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Secondary Outcome Measure Information:
Title
PTSD Symptom change (IES-R)
Description
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.
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).
Other Pre-specified Outcome Measures:
Title
Brief Symptom Inventory
Description
The Brief Symptom Inventory (BSI) is a measure of general psychological distress.
Time Frame
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Title
Inventory of Interpersonal Problems (IIP)
Description
The IIP is a widely used instrument to measure interpersonal distress.
Time Frame
change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willi Butollo, Prof.
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
LS für Klinische Psychologie und Psychotherapie
City
Munich
ZIP/Postal Code
80802
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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