Posttraumatic Stress DisorderNCT01693497
Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder
A study testing Dialogical exposure therapy and Cognitive Processing Therapy (German Adaptation) in people with Posttraumatic Stress Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Dialogical exposure therapy and Cognitive Processing Therapy (German Adaptation)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2002to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- main diagnosis of posttraumatic stress disorder
- time since trauma is at least three months
Who cannot join
- acute suicidal ideation
- severe personality pathology
- substance dependence
- early childhood trauma (e.g. child sexual abuse)
- history of psychosis
- dissociative identity disorder
Show all 11Show fewer
- neurological impairment (e.g. craniocerebral injury with functional impairment)
- severe pre-traumatic depression
- ongoing psychotherapy
- lack of motivation
- lack of German language skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Dialogical exposure therapy, Cognitive Processing Therapy (German Adaptation)
- Keywords
- Posttraumatic Stress Disorder, PTSD, psychotherapy, randomized trial, gestalt
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialogical exposure therapyBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dialogical exposure therapy | Experimental | Psychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques. Receives: Behavioral: Dialogical exposure therapy |
| Cognitive Processing Therapy | Active comparator | Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993. Receives: Behavioral: Cognitive Processing Therapy (German Adaptation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Secondary outcomes (1)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2002
- Primary completionSep 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willi Butollo, Ludwig-Maximilians - University of Munich
- Investigators
- Willi Butollo, Prof., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693497
- Sponsor's protocol ID
- Gestalt therapy for PTSD
- Status last verified
- Sep 2012
- First submitted
- 18 Sep 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy
- ClinicalTrials.gov ID
- NCT01693497
- Acronym / sponsor ID
- Gestalt therapy for PTSD
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, PTSD, psychotherapy, randomized trial, gestalt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialogical exposure therapy | Experimental | Behavioral: Dialogical exposure therapyPsychotherapy based on a manual integrating Gestalt principles with cognitive-behavioral techniques. |
| Cognitive Processing Therapy | Active comparator | Behavioral: Cognitive Processing Therapy (German Adaptation)Cognitive Processing Therapy, a cognitive behavioral psychotherapy for PTSD patients. Based on a German manual adapted from Resick and Schnicke, 1993. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- main diagnosis of posttraumatic stress disorder
- time since trauma is at least three months
Key exclusion criteria (11 listed)
- acute suicidal ideation
- severe personality pathology
- substance dependence
- early childhood trauma (e.g. child sexual abuse)
- history of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialogical exposure therapyThis 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. | Behavioural | Dialogical exposure therapy |
| 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. | Behavioural | Cognitive Processing Therapy |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willi Butollo, Prof. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialogical exposure therapy and Cognitive Processing Therapy (German Adaptation) in people with Posttraumatic Stress Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTBS Symptom Severity (time frame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.