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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014