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CompletedNCT01443182Updated Sep 13, 2018

Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma

An interventional study of STAIR and MPE in Posttraumatic Stress Disorder (PTSD), sponsored by VU University of Amsterdam. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by VU University of Amsterdam · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Posttraumatic Stress Disorder (PTSD)
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 68 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

VU University of Amsterdam is the lead sponsor of 47 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    STAIR + MPE

    A two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2

    Behavioral: STAIR · Behavioral: MPE

  • Active comparator
    STAIR + EMDR

    a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)

    Behavioral: STAIR · Behavioral: EMDR

Interventions

  • BehavioralSTAIR

    Skills Training in Affective and Interpersonal Regulation

  • BehavioralMPE

    Modified prolonged exposure (MPE)

  • BehavioralEMDR

    Eye movement desensitization and reprocessing

06

What researchers measure

Primary outcomes

  1. 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))

  2. 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

Secondary outcomes

  1. 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))

  2. 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))

  3. 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))

  4. 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))

  5. 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))

07

Study locations

1 site
  • PsyQ
    Zaandam, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01443182
Lead sponsor
VU University of Amsterdam
Responsible party
Paul M.G.Emmelkamp (Professor, University of Amsterdam) — Principal investigator
First posted
Sep 29, 2011
Start date
Sep 2011
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 13, 2018

Study contacts

Thomas Ehring, PhD
study chair · University of Amsterdam
Katharina Meyerbröker
study chair · University of Amsterdam

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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