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

Sponsor
University of Amsterdam (Other)
Overall Status
Completed
CT.gov ID
NCT01464892
Collaborator
(none)
61
Enrollment
1
Location
3
Arms
72
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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:

  1. Imagery Rescripting

  2. STAIR + Imagery Rescripting

  3. Wait-list control

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Imagery Rescripting and Reprocessing Therapy
  • Behavioral: STAIR + Imagery Rescripting
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
Actual Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks [baseline and 8 weeks]

      comparison STAIR vs ImRs vs WL

    2. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks [baseline and 8 weeks]

      comparison STAIR vs ImRs vs WL

    Secondary Outcome Measures

    1. Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks [baseline and 8 weeks]

    2. Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks [baseline and 8 weeks]

    3. Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks [baseline and 8 weeks]

    4. Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks [baseline and 8 weeks]

    5. Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks [baseline and 8 weeks]

    6. Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks [baseline and 8 weeks]

    7. Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks [baseline and 8 weeks]

    8. 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) [baseline and max.24 weeks (depending on condition)]

    9. 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). [baseline and max. 36 weeks (depending on condition)]

    10. 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) [baseline and max.24 weeks (depending on condition)]

    11. 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). [baseline and max. 36 weeks (depending on condition)]

    12. 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). [baseline and max 24 weeks (depending on condition)]

    13. 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). [baseline and max 36 weeks (depending on condition)]

    14. 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 [baseline and max 24 weeks (depending on condition)]

    15. 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). [baseline and max 36 weeks (depdending on condition)]

    16. 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). [baseline and max 24 weeks (depending on condition)]

    17. 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). [baseline and max 36 weeks (depdending on condition)]

    18. 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) [baseline and max 24 weeks (depending on condition)]

    19. 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). [baseline and max 36 weeks (depdending on condition)]

    20. 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) [baseline and max 24 weeks (depending on condition)]

    21. 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). [baseline and max 36 weeks (depdending on condition)]

    22. 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) [baseline and max 24 weeks (depending on condition)]

    23. 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). [baseline and max 36 weeks (depdending on condition)]

    24. 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) [baseline and max 36 weeks (depdending on condition)]

    25. 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). [baseline and max 36 weeks (depdending on condition)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Amsterdam Amsterdam Netherlands 1018 XA

    Sponsors and Collaborators

    • University of Amsterdam

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mrs. M. Kindt, Professor of Experimental and Clinical Psychology, University of Amsterdam
    ClinicalTrials.gov Identifier:
    NCT01464892
    Other Study ID Numbers:
    • 2009-KP-877
    First Posted:
    Nov 4, 2011
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Mrs. M. Kindt, Professor of Experimental and Clinical Psychology, 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:
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic

    Study Results

    No Results Posted as of Dec 9, 2021