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OpenTrials
Completed

NCT Number: NCT01443182

Treatment of Posttraumatic Stress Disorder (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.

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PsyQ

Zaandam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAIR

Behavioral

Skills Training in Affective and Interpersonal Regulation

MPE

Behavioral

Modified prolonged exposure (MPE)

EMDR

Behavioral

Eye movement desensitization and reprocessing

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))

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

Treatment of PTSD in Adult Survivors of Early Chronic Interpersonal Trauma

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2011
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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