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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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

Condition Intervention Phase
Posttraumatic Stress Disorder (PTSD)
Behavioral: Imagery Rescripting and Reprocessing Therapy
Behavioral: STAIR + Imagery Rescripting
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imagery Rescripting Behavioral: Imagery Rescripting and Reprocessing Therapy
This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
Other Name: IRRT
Active Comparator: STAIR plus Imagery Rescripting 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.
No Intervention: Wait-list control
Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464892

Contacts
Contact: Sandra Raabe, MSC *31-(0)20-525 ext 6811 s.raabe@uva.nl

Locations
Netherlands
University of Amsterdam Recruiting
Amsterdam, Netherlands, 1018 XA
Contact: Sandra Raabe, MSc    *31-(0)20-525 ext 6811    s.raabe@uva.nl   
Sponsors and Collaborators
VU University of Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Merel Kindt, Prof dr VU University of Amsterdam
  More Information

No publications provided

Responsible Party: Mrs. M. Kindt, Professor of Experimental and Clinical Psychology, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01464892     History of Changes
Other Study ID Numbers: 2009-KP-877
Study First Received: October 25, 2011
Last Updated: November 3, 2011
Health Authority: Netherlands: University of Amsterdam, department of psychology ethics committee

Keywords provided by VU University of Amsterdam:
Imagery rescripting
Imagery rescripting and reprocessing therapy
Skills Training in affective and interpersonal regulation
Post-traumatic Stress Disorder
Childhood abuse
Childhood sexual abuse

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014