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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464892
Other study ID # 2009-KP-877
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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