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

December 1, 2021 updated by: Mrs. M. Kindt, University of Amsterdam

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1018 XA
        • University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
Time Frame: baseline and 8 weeks
comparison STAIR vs ImRs vs WL
baseline and 8 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
Time Frame: baseline and 8 weeks
comparison STAIR vs ImRs vs WL
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Posttreatment: Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs 24 weeks (WL/STAIR/ImRs)
Time Frame: baseline and max.24 weeks (depending on condition)
baseline and max.24 weeks (depending on condition)
12-week follow-up: Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR/ImRs).
Time Frame: baseline and max. 36 weeks (depending on condition)
baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR/ImRs)
Time Frame: baseline and max.24 weeks (depending on condition)
baseline and max.24 weeks (depending on condition)
12-week fu: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR)./ImRs).
Time Frame: baseline and max. 36 weeks (depending on condition)
baseline and max. 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Beck Depression Inventory (BDI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
Change from Baseline in Beck Depression Inventory (BDI) at 20 weeks (ImRs) vs 12-week-fu: 8 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depending on condition)
baseline and max 36 weeks (depending on condition)
Post-treatment: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR).
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Inventory of Interpersonal Problems (IIP) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Dissociation Questionnaire (DIS-Q) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in WHO-Quality of Life(WHO-QL) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in WHO-Quality of Life(WHO-QL) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Difficulties in Emotion Regulation Scale Post-treatment: Change from Difficulties in Emotion Regulation Scale (DERS) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time Frame: baseline and max 24 weeks (depending on condition)
baseline and max 24 weeks (depending on condition)
12-week FU: Change from Baseline in Difficulties in Emotion Regulation Scale (DERS) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
Post-treatment: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 8 weeks (ImRs) vs 16 weeks (STAIR/ImRs; WL/ImRs) vs. 24 weeks (WL/STAIR)
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)
12-week FU: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1) at 20 weeks (ImRs) vs 28 weeks (STAIR/ImRs; WL/ImRs) vs. 36 weeks (WL/STAIR).
Time Frame: baseline and max 36 weeks (depdending on condition)
baseline and max 36 weeks (depdending on condition)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Amsterdam

Investigators

  • Principal Investigator: Merel Kindt, Prof dr, University of Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-KP-877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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