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

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

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 May 19, 2013