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

Study Overview
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Brief Summary
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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

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

Conditions
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Posttraumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Behavioral: Imagery Rescripting and Reprocessing Therapy
* Behavioral: STAIR + Imagery Rescripting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imagery Rescripting<br> | Behavioral: Imagery Rescripting and Reprocessing Therapy<br>* This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting<br>* Other names: IRRT;|
| Active Comparator: STAIR plus Imagery Rescripting<br> | Behavioral: STAIR + Imagery Rescripting<br>* 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.<br>|
| No Intervention: Wait-list control<br>Participants from this arm are randomized to the two active conditions after 8 weeks of waiting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks | comparison STAIR vs ImRs vs WL | baseline and 8 weeks | 
| Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks | comparison STAIR vs ImRs vs WL | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks |  | baseline and 8 weeks | 
| Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)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 Dissociation Questionnaire (DIS-Q)at 8 weeks |  | baseline and 8 weeks | 
| Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks |  | baseline and 8 weeks | 
| 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 | 
| 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) | 
| 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 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 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 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 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imagery rescripting, Imagery rescripting and reprocessing therapy, Skills Training in affective and interpersonal regulation, Post-traumatic Stress Disorder, Childhood abuse, Childhood sexual abuse