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Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)

Primary Purpose

Posttraumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Imaginal exposure

Imagery rescripting

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Modum Bad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Imaginal exposure

Imagery rescripting

Arm Description

Outcomes

Primary Outcome Measures

PTSD symptoms

Secondary Outcome Measures

General psychiatric symptoms

Full Information

NCT ID

NCT00891098

First Posted

April 30, 2009

Last Updated

June 4, 2013

Sponsor

Modum Bad

Collaborators

University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT00891098

Brief Title

Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)

Official Title

Comparing Imaginal Exposure (IE) and Imagery Rescripting and Reprocessing Therapy (IRRT) in the Treatment of Posttraumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Modum Bad

Collaborators

University of Oslo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Imaginal exposure

Arm Type

Active Comparator

Arm Title

Imagery rescripting

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Imaginal exposure

Other Intervention Name(s)

prolonged exposure, pe

Intervention Description

7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual

Intervention Type

Behavioral

Intervention Name(s)

Imagery rescripting

Other Intervention Name(s)

rescripting, irrt

Intervention Description

7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual

Primary Outcome Measure Information:

Title

PTSD symptoms

Time Frame

pretreatment, weekly during treatment, posttreatment, followup

Secondary Outcome Measure Information:

Title

General psychiatric symptoms

Time Frame

pretreatment, weekly during treatment, postttreatment, followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asle Hoffart, PhD

Organizational Affiliation

Modum Bad and University of Oslo

Official's Role

Study Chair

Facility Information:

Facility Name

Modum Bad

City

Vikersund

State/Province

Buskerud

ZIP/Postal Code

3370

Country

Norway

12. IPD Sharing Statement

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Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)

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