- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693497
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Dialogical exposure therapy
Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques.
|
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.
|
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
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
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
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.
Investigators
- 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
September 1, 2002
Primary Completion (ACTUAL)
September 1, 2011
Study Completion (ACTUAL)
April 1, 2012
Study Registration Dates
First Submitted
September 18, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (ESTIMATE)
September 26, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 26, 2012
Last Update Submitted That Met QC Criteria
September 24, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Posttraumatic Stress Disorder
-
Sofie FolkeAarhus University Hospital; Copenhagen Trial Unit, Center for Clinical Intervention... and other collaboratorsNot yet recruiting
-
University Hospital, ToursCompletedPostTraumatic Stress DisorderFrance
-
ARQ National Psychotrauma CentreLeiden University Medical CenterEnrolling by invitationPosttraumatic Stress Disorder (PTSD)Netherlands
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Icahn School of Medicine at Mount SinaiCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Berlin Center for the Treatment of Torture VictimsCompletedPosttraumatic Stress Disorder (PTSD)Germany
-
TEMPVA Research Group, Inc.C.R.Darnall Army Medical Center; VA Boston Healthcare System; Central Texas Veterans...UnknownPosttraumatic Stress Disorder, Combat-relatedUnited States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Michael E. DeBakey VA Medical CenterSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompleted
Clinical Trials on Dialogical exposure therapy
-
Tampere UniversityRecruitingFamily Relations | Family Dynamics | Family SupportFinland
-
Emory UniversityCenters for Disease Control and PreventionWithdrawnPost Traumatic Stress Disorder, PTSD
-
University of LouisvilleCompletedAnorexia Nervosa | Bulimia Nervosa | Eating Disorder | ExposureUnited States
-
University of LouisvilleCompletedAnorexia Nervosa | Binge-Eating Disorder | Bulimia Nervosa | Therapy | Eating Disorder | ExposureUnited States
-
Universidad de GranadaUnknown
-
Palo Alto Veterans Institute for ResearchCompletedWritten Exposure Therapy | Imaginal Exposure TherapyUnited States
-
University of Texas at AustinNational Institute of Mental Health (NIMH)CompletedSpecific PhobiaUnited States
-
Georgia State UniversityVirtually Better, Inc.CompletedSocial Anxiety DisorderUnited States
-
Universitätsklinikum Hamburg-EppendorfUnknownObsessive-compulsive Disorder (OCD)Germany
-
Emory UniversityCompleted