- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891098
Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)
June 4, 2013 updated by: Asle Hoffart, Modum Bad
Comparing Imaginal Exposure (IE) and Imagery Rescripting and Reprocessing Therapy (IRRT) in the Treatment of Posttraumatic Stress Disorder (PTSD)
The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by which emotions that are predominant among current symptoms, e.g.
fear, anger, guilt, shame.
Different treatment procedures for processing traumatic memories may resolve different emotions.
This study compares two different treatment procedures of working with trauma memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to test this.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The main objectives of this study are:
- To assess the relative efficacy of the two procedures in inpatient treatment for PTSD
- To assess whether the predominant emotions in the traumatic memories moderate the outcome of the different procedures
- To assess whether theory-derived constructs mediate outcome and whether the mediating relationships are different in the two treatments
- To provide a theoretical account of the two models
- To psychometrically evaluate 3 new measures
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Buskerud
-
Vikersund, Buskerud, Norway, 3370
- Modum Bad
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- DSM-IV diagnosis of PTSD identified as primary diagnosis
- Accepts withdrawal of all psychotropic medication
Exclusion Criteria:
- Extensive dissociative symptoms or current psychosis,
- Current suicidal risk,
- Extensive current substance or alcohol abuse, or
- Ongoing trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Imaginal exposure
|
7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual
Other Names:
|
|
Experimental: Imagery rescripting
|
7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PTSD symptoms
Time Frame: pretreatment, weekly during treatment, posttreatment, followup
|
pretreatment, weekly during treatment, posttreatment, followup
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
General psychiatric symptoms
Time Frame: pretreatment, weekly during treatment, postttreatment, followup
|
pretreatment, weekly during treatment, postttreatment, followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Asle Hoffart, PhD, Modum Bad and University of Oslo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
April 30, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (Estimate)
May 1, 2009
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
June 4, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-Hoffart
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.