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

Purpose

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

Condition	Intervention	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Imagery Rescripting and Reprocessing Therapy Behavioral: STAIR + Imagery Rescripting	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:

Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Clinician-Administered PTSD Scale (CAPS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 8 weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Posttraumatic Diagnostic Scale (PDS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Beck Depression Inventory (BDI)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Beck Depression Inventory (BDI)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Beck Depression Inventory (BDI)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Inventory of Interpersonal Problems (IIP)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in WHO-Quality of Life(WHO-QL)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in WHO-Quality of Life(WHO-QL)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in WHO-Quality of Life(WHO-QL)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 28 weeks [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 68 weeks [ Time Frame: baseline and 68 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2011
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464892

Contacts

Contact: Sandra Raabe, MSC

*31-(0)20-525 ext 6811

s.raabe@uva.nl

Locations

Netherlands
University of Amsterdam	Recruiting
Amsterdam, Netherlands, 1018 XA
Contact: Sandra Raabe, MSc *31-(0)20-525 ext 6811 s.raabe@uva.nl

Sponsors and Collaborators

VU University of Amsterdam

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

Principal Investigator:

Merel Kindt, Prof dr

VU University of Amsterdam

More Information

No publications provided

Responsible Party:	Mrs. M. Kindt, Professor of Experimental and Clinical Psychology, VU University of Amsterdam
ClinicalTrials.gov Identifier:	NCT01464892 History of Changes
Other Study ID Numbers:	2009-KP-877
Study First Received:	October 25, 2011
Last Updated:	November 3, 2011
Health Authority:	Netherlands: University of Amsterdam, department of psychology ethics committee

Keywords provided by VU 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, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013