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

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
STAIR
MPE
EMDR
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PsyQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STAIR + MPE

STAIR + EMDR

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)
Posttraumatic Diagnostic Scale (PDS)

Secondary Outcome Measures

Beck Depression Inventory (BDI)
Beck Anxiety Inventory (BAI)
Dissociative Experiences Scale (DES)
Difficulties in Emotion Regulation Scale (DERS)
Inventory of Interpersonal Problems (IIP)

Full Information

First Posted
September 27, 2011
Last Updated
September 11, 2018
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01443182
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAIR + MPE
Arm Type
Experimental
Arm Description
A two-phased treatment with Skills Training in Affective and Interpersonal Regulation (STAIR) in Phase 1 en modified prolonged exposure (MPE) in Phase 2
Arm Title
STAIR + EMDR
Arm Type
Active Comparator
Arm Description
a two-phase treatment Phase 1: Skills Training in Affective and Interpersonal Regulation (STAIR) Phase 2: Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Type
Behavioral
Intervention Name(s)
STAIR
Intervention Description
Skills Training in Affective and Interpersonal Regulation
Intervention Type
Behavioral
Intervention Name(s)
MPE
Intervention Description
Modified prolonged exposure (MPE)
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
Eye movement desensitization and reprocessing
Primary Outcome Measure Information:
Title
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))
Title
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 Outcome Measure Information:
Title
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))
Title
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))
Title
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))
Title
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))
Title
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))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ehring, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katharina Meyerbröker
Organizational Affiliation
University of Amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
PsyQ
City
Zaandam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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