NCT01464892

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. 1.Imagery Rescripting
  2. 2.STAIR + Imagery Rescripting
  3. 3.Wait-list control

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

6 years

First QC Date

October 25, 2011

Last Update Submit

December 1, 2021

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Imagery rescriptingImagery rescripting and reprocessing therapySkills Training in affective and interpersonal regulationPost-traumatic Stress DisorderChildhood abuseChildhood sexual abuse

Outcome Measures

Primary Outcomes (2)

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

    comparison STAIR vs ImRs vs WL

    baseline and 8 weeks

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

    comparison STAIR vs ImRs vs WL

    baseline and 8 weeks

Secondary Outcomes (25)

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

    baseline and 8 weeks

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

    baseline and 8 weeks

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

    baseline and 8 weeks

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

    baseline and 8 weeks

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

    baseline and 8 weeks

  • +20 more secondary outcomes

Study Arms (3)

Imagery Rescripting

EXPERIMENTAL
Behavioral: Imagery Rescripting and Reprocessing Therapy

STAIR plus Imagery Rescripting

ACTIVE COMPARATOR
Behavioral: STAIR + Imagery Rescripting

Wait-list control

NO INTERVENTION

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

Interventions

Imagery Rescripting and Reprocessing TherapyBEHAVIORAL

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

Also known as: IRRT
Imagery Rescripting
STAIR + Imagery RescriptingBEHAVIORAL

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.

STAIR plus Imagery Rescripting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Amsterdam

Amsterdam, 1018 XA, Netherlands

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Merel Kindt, Prof dr

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experimental and Clinical Psychology

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 4, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 9, 2021

Record last verified: 2021-12

Locations

NL(1)