Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder (ptsd)
Treatments imagery rescripting and reprocessing therapy, stair + imagery rescripting
Phase phase 2
Sponsor VU University of Amsterdam
Collaborator Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date October 2011
End date June 2016
Trial size 61 participants
Trial identifier NCT01464892, 2009-KP-877

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
imagery rescripting and reprocessing therapy IRRT
This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
(Active Comparator)
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)
Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.

Primary Outcomes

Measure
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 16 weeks
time frame: baseline and 16 weeks

Secondary Outcomes

Measure
Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 8 weeks
time frame: baseline and 8 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Beck Depression Inventory (BDI)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Beck Depression Inventory (BDI)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Beck Depression Inventory (BDI)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in WHO-Quality of Life(WHO-QL)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 68 weeks
time frame: baseline and 68 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 16 weeks
time frame: baseline and 16 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 28 weeks
time frame: baseline and 28 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 68 weeks
time frame: baseline and 68 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma
Principal investigator Merel Kindt, Prof dr
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by VU University of Amsterdam.