Posttraumatic Stress Disorder (PTSD)NCT01443182
Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma
A study testing STAIR, MPE and EMDR in people with Posttraumatic Stress Disorder (PTSD), run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- STAIR, MPE and EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Jun 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting DSM-IV criteria for PTSD
- having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse)
- at least 18 years of age
- having sufficient fluency in Dutch to complete treatment and research protocol
- participants using prescribed anti-depressant medication are required 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
- psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
- current use of tranquilizers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma
Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- STAIR, MPE, 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.
STAIRBehavioural
Skills Training in Affective and Interpersonal Regulation
MPEBehavioural
Modified prolonged exposure (MPE)
EMDRBehavioural
Eye movement desensitization and reprocessing
| Study group | Role | What they receive |
|---|---|---|
| STAIR + MPE | Experimental | A two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2 Receives: Behavioral: STAIR; Behavioral: MPE |
| STAIR + EMDR | Active comparator | a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR) Receives: Behavioral: STAIR; Behavioral: EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
Measured: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Posttraumatic Diagnostic Scale (PDS)
Measured: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up). Before each treatment session
Secondary outcomes (5)
Beck Depression Inventory (BDI)
Measured: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Beck Anxiety Inventory (BAI)
Measured: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Dissociative Experiences Scale (DES)
Measured: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Difficulties in Emotion Regulation Scale (DERS)
Measured: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Inventory of Interpersonal Problems (IIP)
Measured: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- 68 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, University of Amsterdam
- Investigators
- Thomas Ehring, PhD, Study chair, University of AmsterdamKatharina Meyerbröker, Study chair, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443182
- Sponsor's protocol ID
- NL31098.097.10
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2011
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wigard I, Meyerbroker K, Ehring T, Topper M, Arntz A, Emmelkamp P. Skills training followed by either EMDR or narrative therapy for posttraumatic stress disorder in adult survivors of childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2024;15(1):2332104. doi: 10.1080/20008066.2024.2332104. Epub 2024 Apr 17.
PubMed 38629403
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
- Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma
- ClinicalTrials.gov ID
- NCT01443182
- Acronym / sponsor ID
- NL31098.097.10
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Sep 2011 (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.
Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAIR + MPE | Experimental | Behavioral: STAIR, Behavioral: MPEA two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2 |
| STAIR + EMDR | Active comparator | Behavioral: STAIR, Behavioral: EMDRa two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- meeting DSM-IV criteria for PTSD
- having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse)
- at least 18 years of age
- having sufficient fluency in Dutch to complete treatment and research protocol
- participants using prescribed anti-depressant medication are required 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 (2 listed)
- psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence
- current use of tranquilizers
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 |
|---|---|---|
| STAIRSkills Training in Affective and Interpersonal Regulation | Behavioural | STAIR + EMDR, STAIR + MPE |
| MPEModified prolonged exposure (MPE) | Behavioural | STAIR + MPE |
| EMDREye movement desensitization and reprocessing | Behavioural | STAIR + EMDR |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Posttraumatic Diagnostic Scale (PDS)
Time frame: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up). Before each treatment session
5 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Beck Anxiety Inventory (BAI)
Time frame: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Dissociative Experiences Scale (DES)
Time frame: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Inventory of Interpersonal Problems (IIP)
Time frame: Pre- (baseline), after the first 8 treatment sessions and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
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.
- Derived from this study: PubMed 38629403Wigard I, Meyerbroker K, Ehring T, Topper M, Arntz A, Emmelkamp P. Skills training followed by either EMDR or narrative therapy for posttraumatic stress disorder in adult survivors of childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2024;15(1):2332104. doi: 10.1080/20008066.2024.2332104. Epub 2024 Apr 17.
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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.
Thomas Ehring, PhD study chair
University of Amsterdam
Katharina Meyerbröker study chair
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 STAIR, MPE and EMDR in people with Posttraumatic Stress Disorder (PTSD), 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 2 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?
Clinician Administered PTSD Scale (CAPS) (time frame: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443182, which also lists 1 linked publication.
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.