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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder (PTSD)
• Interventions: Behavioral: STAIR + Imagery Rescripting; Behavioral: Imagery Rescripting and Reprocessing Therapy

• Registration Number: NCT01464892
• Lead Sponsor: University of Amsterdam

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 available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
STAIR plus Imagery Rescripting	STAIR + Imagery Rescripting	-
Imagery Rescripting	Imagery Rescripting and Reprocessing Therapy	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks	baseline and 8 weeks	comparison STAIR vs ImRs vs WL
Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks	baseline and 8 weeks	comparison STAIR vs ImRs vs WL

Secondary Outcome Measures

Name	Time	Method
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)
Change from Baseline in Beck Depression Inventory (BDI)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 WHO-Quality of Life(WHO-QL)at 8 weeks	baseline and 8 weeks
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)
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)
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)
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)
Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks	baseline and 8 weeks
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)
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)
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)
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)
Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks	baseline and 8 weeks
Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks	baseline and 8 weeks
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)
Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks	baseline and 8 weeks
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)
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)
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)
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)
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)
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)
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)
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)

Trial Locations

Locations (1)

University of Amsterdam; 🇳🇱 Amsterdam, Netherlands