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

Primary Purpose

Posttraumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Imagery Rescripting and Reprocessing Therapy
STAIR + Imagery Rescripting
Sponsored by
University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder (PTSD) focused on measuring Imagery rescripting, Imagery rescripting and reprocessing therapy, Skills Training in affective and interpersonal regulation, Post-traumatic Stress Disorder, Childhood abuse, Childhood sexual abuse

Eligibility Criteria

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

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

Sites / Locations

  • University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Imagery Rescripting

STAIR plus Imagery Rescripting

Wait-list control

Arm Description

Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.

Outcomes

Primary Outcome Measures

Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
comparison STAIR vs ImRs vs WL
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
comparison STAIR vs ImRs vs WL

Secondary Outcome Measures

Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 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)
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).
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)
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).
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).
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).
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
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).
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).
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).
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)
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).
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)
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).
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)
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).
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)
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).

Full Information

First Posted
October 25, 2011
Last Updated
December 1, 2021
Sponsor
University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01464892
Brief Title
Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
Official Title
Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Imagery Rescripting STAIR + Imagery Rescripting Wait-list control

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
Imagery rescripting, Imagery rescripting and reprocessing therapy, Skills Training in affective and interpersonal regulation, Post-traumatic Stress Disorder, Childhood abuse, Childhood sexual abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imagery Rescripting
Arm Type
Experimental
Arm Title
STAIR plus Imagery Rescripting
Arm Type
Active Comparator
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rescripting and Reprocessing Therapy
Other Intervention Name(s)
IRRT
Intervention Description
This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
Intervention Type
Behavioral
Intervention Name(s)
STAIR + Imagery Rescripting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
Description
comparison STAIR vs ImRs vs WL
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
Description
comparison STAIR vs ImRs vs WL
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
Time Frame
baseline and 8 weeks
Title
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
Time Frame
baseline and 8 weeks
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merel Kindt, Prof dr
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1018 XA
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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