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

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ClinicalTrials.gov Identifier: NCT01464892
Recruitment Status : Unknown
Verified December 2015 by Mrs. M. Kindt, VU University of Amsterdam.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2011
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Mrs. M. Kindt, VU University of Amsterdam

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE November 4, 2011
Last Update Posted Date December 21, 2015
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 16 weeks [ Time Frame: baseline and 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 8 weeks [ Time Frame: baseline and 8 weeks ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Beck Depression Inventory (BDI)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Inventory of Interpersonal Problems (IIP)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Dissociation Questionnaire (DIS-Q)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in WHO-Quality of Life(WHO-QL)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 68 weeks [ Time Frame: baseline and 68 weeks ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 16 weeks [ Time Frame: baseline and 16 weeks ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 28 weeks [ Time Frame: baseline and 28 weeks ]
  • Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 68 weeks [ Time Frame: baseline and 68 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
Official Title  ICMJE Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder (PTSD)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 18, 2015)
61
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2011)
90
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01464892
Other Study ID Numbers  ICMJE 2009-KP-877
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mrs. M. Kindt, VU University of Amsterdam
Study Sponsor  ICMJE VU University of Amsterdam
Collaborators  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators  ICMJE
Principal Investigator: Merel Kindt, Prof dr University of Amsterdam
PRS Account VU University of Amsterdam
Verification Date December 2015

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