Stress Disorders, Post-TraumaticNCT00716638
Trauma-focused CBT Versus EMDR in the Treatment of Posttraumatic Stress Disorder
A study testing Trauma-focused Cognitive Behavior Therapy and Eye Movement Desensitization and Reprocessing (EMDR) in people with Stress Disorders, Post-Traumatic, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Trauma-focused Cognitive Behavior Therapy and Eye Movement Desensitization and Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Nov 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
- PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
- Age between 18 and 70
- Sufficient fluency in Dutch to complete treatment and research protocol
- If participants are using anti-depressants, they need to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.
Who cannot join
- Dementia or other severe cognitive impairment
- Psychosis
- Depression with suicidal ideation
- Bipolar disorder
- Borderline Personality Disorder
- Anti-social personality disorder
Show all 9Show fewer
- Substance dependence
- Current use of tranquilizers
- Exposure to prolonged and/or chronic trauma ("type-II-trauma")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
This study will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Trauma-focused Cognitive Behavior Therapy, Eye Movement Desensitization and Reprocessing (EMDR)
- 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.
Trauma-focused Cognitive Behavior TherapyBehavioural
This intervention comprises 10 sessions of trauma-focused cognitive behavior therapy for PTSD with the components (a) prolonged imaginal exposure, (b) in vivo exposure, and (c) cognitive restructuring.
Eye Movement Desensitization and Reprocessing (EMDR)Behavioural
This intervention comprises 10 sessions of EMDR according to the standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Trauma-focused Cognitive Behavior Therapy (TF-CBT) Receives: Behavioral: Trauma-focused Cognitive Behavior Therapy |
| Treatment group 2 | Experimental | Eye Movement Desensitization and Reprocessing (EMDR) Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)
Measured: Assessed at post-treatment, 3 months and 12 months follow-up
Secondary outcomes (3)
Depressive symptom severity (Beck Depression Inventory, BDI)
Measured: assessed at post-treatment, 3 months and 12 months follow-up
Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)
Measured: assessed at posttreatment, 3 months and 12 months follow-up
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)
Measured: post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul MG Emmelkamp, Professor, Principal investigator, University of AmsterdamThomas Ehring, PhD, Study director, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716638
- Sponsor's protocol ID
- 2008-KP-343
- Status last verified
- Sep 2018
- First submitted
- 14 Jul 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-focused CBT vs. EMDR in the Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00716638
- Acronym / sponsor ID
- 2008-KP-343
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Jul 2008 (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 will evaluate the effectiveness of trauma-focused cognitive behaviour therapy (TF-CBT) versus eye movement desensitization and reprocessing (EMDR) in the treatment of trauma survivors with post-traumatic stress disorder (PTSD). Patients will be randomly assigned to TF-CBT or EMDR. Follow-up assessments will be conducted at 3 and 12 months post-treatment. In addition to comparing the efficacy of the two protocols, an additional focus will lie on identifying predictors for treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Behavioral: Trauma-focused Cognitive Behavior TherapyTrauma-focused Cognitive Behavior Therapy (TF-CBT) |
| Treatment group 2 | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)Eye Movement Desensitization and Reprocessing (EMDR) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A full diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (criteria for intrusive re-experiencing are fulfilled and either three avoidance/numbing symptoms or two hyperarousal symptoms are present)
- PTSD is related to one or more single-event traumas and participants have a clear memory of this event/these events (sufficient for constructing scenes to be used in exposure)
- Age between 18 and 70
- Sufficient fluency in Dutch to complete treatment and research protocol
- If participants are using anti-depressants, they need to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment.
Key exclusion criteria (9 listed)
- Dementia or other severe cognitive impairment
- Psychosis
- Depression with suicidal ideation
- Bipolar disorder
- Borderline Personality Disorder
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 |
|---|---|---|
| Trauma-focused Cognitive Behavior TherapyThis intervention comprises 10 sessions of trauma-focused cognitive behavior therapy for PTSD with the components (a) prolonged imaginal exposure, (b) in vivo exposure, and (c) cognitive restructuring. | Behavioural | Treatment group 1 |
| Eye Movement Desensitization and Reprocessing (EMDR)This intervention comprises 10 sessions of EMDR according to the standard protocol. | Behavioural | Treatment group 2 |
Primary outcome
PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS)
Time frame: Assessed at post-treatment, 3 months and 12 months follow-up
3 secondary outcomes
Depressive symptom severity (Beck Depression Inventory, BDI)
Time frame: assessed at post-treatment, 3 months and 12 months follow-up
Severity of anxiety symptoms (Beck Anxiety Inventory, BAI)
Time frame: assessed at posttreatment, 3 months and 12 months follow-up
Trauma-related appraisal (Posttraumatic Cognitions Inventory, PTCI)
Time frame: post-treatment
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 13 Sep 2018.
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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.
Paul MG Emmelkamp, Professor principal investigator
University of Amsterdam
Thomas Ehring, PhD study director
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused Cognitive Behavior Therapy and Eye Movement Desensitization and Reprocessing (EMDR) in people with Stress Disorders, Post-Traumatic, run by VU University of Amsterdam at 1 site in Netherlands.
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 5 inclusion and 9 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 13 Sep 2018. 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 Netherlands. 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?
PTSD symptom severity: (a) interviewer rating (PSS-I); (b) self-report (PDS) (time frame: Assessed at post-treatment, 3 months and 12 months follow-up). 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 13 Sep 2018.