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

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464892
• Other study ID #: 2009-KP-877
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 2017

Study information

• Verified date: December 2021
• Source: University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Netherlands	University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks	comparison STAIR vs ImRs vs WL	baseline and 8 weeks
Primary	Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks	comparison STAIR vs ImRs vs WL	baseline and 8 weeks
Secondary	Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks		baseline and 8 weeks
Secondary	Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks		baseline and 8 weeks
Secondary	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)		baseline and max.24 weeks (depending on condition)
Secondary	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).		baseline and max. 36 weeks (depending on condition)
Secondary	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)		baseline and max.24 weeks (depending on condition)
Secondary	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).		baseline and max. 36 weeks (depending on condition)
Secondary	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).		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depending on condition)
Secondary	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		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)
Secondary	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).		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)
Secondary	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)		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)
Secondary	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)		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)
Secondary	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)		baseline and max 24 weeks (depending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)
Secondary	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)		baseline and max 36 weeks (depdending on condition)
Secondary	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).		baseline and max 36 weeks (depdending on condition)