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

• ClinicalTrials.gov Identifier: NCT01464892
• Recruitment Status: Unknown
• First Posted: November 4, 2011
• Last Update Posted: December 21, 2015
• Sponsor: VU University of Amsterdam
• Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Information provided by (Responsible Party): Mrs. M. Kindt, VU University of Amsterdam

Tracking Information

• First Submitted Date: October 25, 2011
• First Posted Date: November 4, 2011
• Last Update Posted Date: December 21, 2015
• Study Start Date: October 2011
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2011)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2011)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma
• Official Title: Rescripting With vs. Without Prior Stabilization in PTSD Following Early Chronic Interpersonal Trauma

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Posttraumatic Stress Disorder (PTSD)

Intervention

• Behavioral: Imagery Rescripting and Reprocessing Therapy
  This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
  Other Name: IRRT
• 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.

Study Arms

• Experimental: Imagery Rescripting
  Intervention: Behavioral: Imagery Rescripting and Reprocessing Therapy
• Active Comparator: STAIR plus Imagery Rescripting
  Intervention: Behavioral: STAIR + Imagery Rescripting
• No Intervention: Wait-list control
  Participants from this arm are randomized to the two active conditions after 8 weeks of waiting.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: December 18, 2015): 61
• Original Estimated Enrollment (submitted: November 3, 2011): 90
• Estimated Study Completion Date: October 2016
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01464892
• Other Study ID Numbers: 2009-KP-877
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mrs. M. Kindt, VU University of Amsterdam
• Study Sponsor: VU University of Amsterdam
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

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

• PRS Account: VU University of Amsterdam
• Verification Date: December 2015