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Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma

This study is currently recruiting participants.
Verified November 2011 by VU University of Amsterdam
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Mrs. M. Kindt, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01464892
First received: October 25, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes

October 25, 2011
November 3, 2011
October 2011
August 2014   (final data collection date for primary outcome measure)
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01464892 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker & Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:

  1. Imagery Rescripting
  2. STAIR + Imagery Rescripting
  3. Wait-list control
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder (PTSD)
  • Behavioral: Imagery Rescripting and Reprocessing Therapy
    This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
    Other Name: IRRT
  • Behavioral: STAIR + Imagery Rescripting
    A two-phased treatment. Phase 1 is comprised of 8 (weekly) sessions of Skills Training in Affective and Interpersonal Skills (STAIR). Phase 2 consists of 16 sessions (twice weekly) of trauma-focused imagery rescripting.
  • Experimental: Imagery Rescripting
    Intervention: Behavioral: Imagery Rescripting and Reprocessing Therapy
  • Active Comparator: STAIR plus Imagery Rescripting
    Intervention: Behavioral: STAIR + Imagery Rescripting
  • No Intervention: Wait-list control
    Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
November 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • a full diagnosis of post-traumatic stress disorder (PTSD) according to DSM-IV
  • having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15
  • between the age of 18 and 65 years
  • sufficient fluency of Dutch to complete treatment and research-protocol
  • participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment

Exclusion Criteria:

  • psychosis
  • bipolar disorder
  • significant cognitive impairment
  • substance dependence
  • current use of benzodiazepines
  • severe suicidal ideation or life-threatening automutilation
  • current trauma or threat
  • unstable living circumstances
  • antisocial personality disorder
  • primary diagnosis of borderline personality disorder
Both
18 Years to 65 Years
No
Contact: Sandra Raabe, MSC *31-(0)20-525 ext 6811 s.raabe@uva.nl
Netherlands
 
NCT01464892
2009-KP-877
Yes
Mrs. M. Kindt, VU University of Amsterdam
VU University of Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Merel Kindt, Prof dr VU University of Amsterdam
VU University of Amsterdam
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP