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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891098
Other study ID # 2-Hoffart
Secondary ID
Status Completed
Phase N/A
First received April 30, 2009
Last updated June 4, 2013
Start date November 2008
Est. completion date November 2012

Study information

Verified date June 2013
Source Modum Bad
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

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.


Description:

The main objectives of this study are:

1. To assess the relative efficacy of the two procedures in inpatient treatment for PTSD

2. To assess whether the predominant emotions in the traumatic memories moderate the outcome of the different procedures

3. To assess whether theory-derived constructs mediate outcome and whether the mediating relationships are different in the two treatments

4. To provide a theoretical account of the two models

5. To psychometrically evaluate 3 new measures


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Imaginal exposure
7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual
Imagery rescripting
7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual

Locations

Country Name City State
Norway Modum Bad Vikersund Buskerud

Sponsors (2)

Lead Sponsor Collaborator
Modum Bad University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD symptoms pretreatment, weekly during treatment, posttreatment, followup No
Secondary General psychiatric symptoms pretreatment, weekly during treatment, postttreatment, followup No
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