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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Willi Butollo, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01693497
First received: September 18, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Dialogical exposure therapy
Behavioral: Cognitive Processing Therapy (German Adaptation)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • PTBS Symptom Severity [ Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment) ] [ Designated as safety issue: No ]
    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) [ 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). ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Brief Symptom Inventory [ Time Frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment) ] [ Designated as safety issue: No ]
    The Brief Symptom Inventory (BSI) is a measure of general psychological distress.

  • 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) ] [ Designated as safety issue: No ]
    The IIP is a widely used instrument to measure interpersonal distress.


Enrollment: 150
Study Start Date: September 2002
Study Completion Date: April 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693497

Locations
Germany
LS für Klinische Psychologie und Psychotherapie
Munich, Germany, 80802
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Willi Butollo, Prof. Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Willi Butollo, Head of Clinical Psychology and Psychotherapy, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01693497     History of Changes
Other Study ID Numbers: Gestalt therapy for PTSD
Study First Received: September 18, 2012
Last Updated: September 24, 2012
Health Authority: Germany: Ethikkommission der LMU München

Keywords provided by Ludwig-Maximilians - University of Munich:
Posttraumatic Stress Disorder
PTSD
psychotherapy
randomized trial
gestalt

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014