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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443182
Other study ID # NL31098.097.10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date June 2016

Study information

Verified date September 2018
Source VU University of Amsterdam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
STAIR
Skills Training in Affective and Interpersonal Regulation
MPE
Modified prolonged exposure (MPE)
EMDR
Eye movement desensitization and reprocessing

Locations

Country Name City State
Netherlands PsyQ Zaandam

Sponsors (1)

Lead Sponsor Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician Administered PTSD Scale (CAPS) Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
Primary Posttraumatic Diagnostic Scale (PDS) 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 Beck Depression Inventory (BDI) 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))
Secondary Beck Anxiety Inventory (BAI) 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))
Secondary Dissociative Experiences Scale (DES) 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))
Secondary Difficulties in Emotion Regulation Scale (DERS) 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))
Secondary Inventory of Interpersonal Problems (IIP) 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))
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