Clinical trial NCT01464892: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Imagery rescripting
Imagery rescripting and reprocessing therapy
Skills Training in affective and interpersonal regulation
Post-traumatic Stress Disorder
Childhood abuse
Childhood sexual abuse
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from Baseline in Clinician-Administered PTSD Scale (CAPS) at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Posttraumatic Diagnostic Scale (PDS) at 8 weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change from Baseline in Beck Depression Inventory (BDI)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Buss-Durkee Hostility Inventory (BDHI)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Inventory of Interpersonal Problems (IIP)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Dissociation Questionnaire (DIS-Q)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in WHO-Quality of Life(WHO-QL)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Difficulties in Emotion Regulation Scale (DERS)at 8 weeks
timeFrame: baseline and 8 weeks
measure: Change from Baseline in Structured Clinical Interview - Axis I (SCID-1)at 8 weeks
timeFrame: baseline and 8 weeks
measure: 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)
timeFrame: baseline and max.24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max. 36 weeks (depending on condition)
measure: 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)
timeFrame: baseline and max.24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max. 36 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depending on condition)
measure: 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
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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).
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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)
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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)
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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)
timeFrame: baseline and max 24 weeks (depending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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)
timeFrame: baseline and max 36 weeks (depdending on condition)
measure: 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).
timeFrame: baseline and max 36 weeks (depdending on condition)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
Study officials:
affiliation: University of Amsterdam
name: Merel Kindt, Prof dr
role: PRINCIPAL_INVESTIGATOR
References: