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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693497
• Other study ID #: Gestalt therapy for PTSD
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: September 24, 2012
• Start date: September 2002
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethikkommission der LMU München
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	LS für Klinische Psychologie und Psychotherapie	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Symptom Inventory	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)	No
Other	Inventory of Interpersonal Problems (IIP)	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)	No
Primary	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.	change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)	No
Secondary	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.	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).	No