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OpenTrials
Completed

NCT Number: NCT01464892

Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (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

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, 1018 XA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imagery Rescripting and Reprocessing Therapy

Behavioral

This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting

Other names: IRRT

STAIR + Imagery Rescripting

Behavioral

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 outcomes

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

    Time frame: baseline and 8 weeks

    comparison STAIR vs ImRs vs WL

  2. Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks

    Time frame: baseline and 8 weeks

    comparison STAIR vs ImRs vs WL

Secondary outcomes

  1. Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

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

    Time frame: baseline and 8 weeks

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

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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).

    Time frame: baseline and max 36 weeks (depdending on condition)

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Registry information

Official study title

Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2011
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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