Posttraumatic Stress DisorderNCT00891098
Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)
A study testing Imaginal exposure and Imagery rescripting in people with Posttraumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Imaginal exposure and Imagery rescripting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2008to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of PTSD identified as primary diagnosis
- Accepts withdrawal of all psychotropic medication
Who cannot join
- Extensive dissociative symptoms or current psychosis,
- Current suicidal risk,
- Extensive current substance or alcohol abuse, or
- Ongoing trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Imaginal exposure, Imagery rescripting
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal exposureBehavioural
Also called prolonged exposure, pe
7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual
Imagery rescriptingBehavioural
Also called rescripting, irrt
7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual
| Study group | Role | What they receive |
|---|---|---|
| Imaginal exposure | Active comparator | Not described Receives: Behavioral: Imaginal exposure |
| Imagery rescripting | Experimental | Not described Receives: Behavioral: Imagery rescripting |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
Measured: pretreatment, weekly during treatment, posttreatment, followup
Secondary outcomes (1)
General psychiatric symptoms
Measured: pretreatment, weekly during treatment, postttreatment, followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Asle Hoffart, Modum Bad
- Investigators
- Asle Hoffart, PhD, Study chair, Modum Bad and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891098
- Sponsor's protocol ID
- 2-Hoffart
- Status last verified
- Jun 2013
- First submitted
- 30 Apr 2009
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Imaginal Exposure (IE) and Imagery Rescripting and Reprocessing Therapy (IRRT) in the Treatment of Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00891098
- Acronym / sponsor ID
- 2-Hoffart
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginal exposure | Active comparator | Behavioral: Imaginal exposure |
| Imagery rescripting | Experimental | Behavioral: Imagery rescripting |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV diagnosis of PTSD identified as primary diagnosis
- Accepts withdrawal of all psychotropic medication
Key exclusion criteria (4 listed)
- Extensive dissociative symptoms or current psychosis,
- Current suicidal risk,
- Extensive current substance or alcohol abuse, or
- Ongoing trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginal exposureAlso: prolonged exposure, pe7 individual sessions of imaginal exposure of trauma memories according to the prolonged exposure treatment manual | Behavioural | Imaginal exposure |
| Imagery rescriptingAlso: rescripting, irrt7 individual sessions of imagery rescripting of trauma memories according to the imagery rescripting and reprocessing therapy manual | Behavioural | Imagery rescripting |
Primary outcome
PTSD symptoms
Time frame: pretreatment, weekly during treatment, posttreatment, followup
1 secondary outcome
General psychiatric symptoms
Time frame: pretreatment, weekly during treatment, postttreatment, followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asle Hoffart, PhD study chair
Modum Bad and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal exposure and Imagery rescripting in people with Posttraumatic Stress Disorder, run by Modum Bad at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (time frame: pretreatment, weekly during treatment, posttreatment, followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.