Clinical trial NCT01443182: Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma
Official title: Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Pre- (baseline) and post-assessment (after treatment termination) and 3 month follow up (3 month after post assessment and 12 month follow up))
measure: Posttraumatic Diagnostic Scale (PDS)
timeFrame: 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:
measure: Beck Depression Inventory (BDI)
timeFrame: 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))
measure: Beck Anxiety Inventory (BAI)
timeFrame: 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))
measure: Dissociative Experiences Scale (DES)
timeFrame: 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))
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 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))
measure: Inventory of Interpersonal Problems (IIP)
timeFrame: 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))
Other outcomes:
Locations:
city: Zaandam
country: Netherlands
facility: PsyQ
Study officials:
affiliation: University of Amsterdam
name: Thomas Ehring, PhD
role: STUDY_CHAIR
affiliation: University of Amsterdam
name: Katharina Meyerbröker
role: STUDY_CHAIR
References: