Posttraumatic Stress DisorderPhase 2NCT00660439
Treatment Effects of Narrative Exposure Therapy
A Phase 2 study testing Narrative Exposure Therapy in people with Posttraumatic Stress Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
This study compares Narrative Exposure Therapy with a Waiting list control group, both consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after Narrative Exposure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Narrative Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to Nov 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posttraumatic Stress Disorder (PTSD)
- Age above 18 years
- Understands, speaks and writes Norwegian
- Informed, written consent
Who cannot join
- Active psychosis
- Active suicidality
- Serious self mutilation
- Active alcohol or drug abuse
- Serious dissociative symptoms
- Disease in nervous system or head injury
- Hormonal disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Western Norway Violence and Traumatic Stress Resource Centre
Bergen, 5021
Tove S. Nordling, Cand Psychol, +47 55 97 66 91, tsno@helse-bergen.no
Tove S. Nordling, Cand Psychol
About this study
Official title: Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder
This study compares Narrative Exposure Therapy with a Waiting list control group, both consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no intervention).
Read the detailed description
In this study we want to compare Narrative Exposure Therapy (NET) to Waiting list controls. Adult patients with diagnosed Posttraumatic Stress Disorder following different types of trauma, will be included. Clinicians in psychiatric outpatient clinics will treat patients with NET, either immediately after assessment, or after a second assessment 3 months later. All patients will also be assessed 1 and 6 months after treatment completion. All patients will be assessed for psychiatric symptoms by the Mini International Neuropsychiatric Interview (version 5.0.0) and the Clinician-Administered PTSD Scale. Patients will also answer several questionnaires (IES-R, SCL-90, BDI-II, DES and UCL). Baseline level of the stress hormone cortisol will be collected in saliva for measuring the diurnal cycle. We will investigate if patients with Posttraumatic Stress Disorder will show more symptom improvement with NET than those on the waiting list (i.e. no intervention) in addition to measuring potential differences in cortisol between the groups.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Narrative Exposure Therapy
- Keywords
- PTSD
- 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.
Narrative Exposure TherapyBehavioural
Also called NET
Psychological treatment, with narration of positive and traumatic events in patients history, including "in vivo" exposure of traumatic events. The narrative is written down by the therapist.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment. Receives: Behavioral: Narrative Exposure Therapy |
| B | No intervention | Waiting list control group, receives no intervention for 3 months after first assessment. A second assessment is then administered and patients receives Narrative Exposure Therapy. Patients are assessed 1 and 6 months after treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric symptoms
Measured: 1 and 6 months after treatment
Secondary outcomes (1)
Cortisol in saliva
Measured: 1 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionNov 2010 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Anne Marita Milde, PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660439
- Sponsor's protocol ID
- NET 40
- Status last verified
- Apr 2008
- First submitted
- 10 Apr 2008
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Narrative Exposure Therapy on Psychiatric Symptoms and Cortisol Levels in Patients With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00660439
- Acronym / sponsor ID
- NET 40
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Norwegian Center for Violence and Traumatic Stress Studies
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 17 Apr 2008 (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.
This study compares Narrative Exposure Therapy with a Waiting list control group, both consists of traumatized patients with diagnosed Posttraumatic Stress Disorder. The main aim is to investigate if the patients psychiatric symptoms and levels of the stress hormone cortisol will improve more after Narrative Exposure Therapy than the Waiting list (i.e. no intervention).
Detailed description
In this study we want to compare Narrative Exposure Therapy (NET) to Waiting list controls. Adult patients with diagnosed Posttraumatic Stress Disorder following different types of trauma, will be included. Clinicians in psychiatric outpatient clinics will treat patients with NET, either immediately after assessment, or after a second assessment 3 months later. All patients will also be assessed 1 and 6 months after treatment completion. All patients will be assessed for psychiatric symptoms by the Mini International Neuropsychiatric Interview (version 5.0.0) and the Clinician-Administered PTSD Scale. Patients will also answer several questionnaires (IES-R, SCL-90, BDI-II, DES and UCL). Baseline level of the stress hormone cortisol will be collected in saliva for measuring the diurnal cycle. We will investigate if patients with Posttraumatic Stress Disorder will show more symptom improvement with NET than those on the waiting list (i.e. no intervention) in addition to measuring potential differences in cortisol between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Narrative Exposure TherapyTreatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment. |
| B | No intervention | –Waiting list control group, receives no intervention for 3 months after first assessment. A second assessment is then administered and patients receives Narrative Exposure Therapy. Patients are assessed 1 and 6 months after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Posttraumatic Stress Disorder (PTSD)
- Age above 18 years
- Understands, speaks and writes Norwegian
- Informed, written consent
Key exclusion criteria (8 listed)
- Active psychosis
- Active suicidality
- Serious self mutilation
- Active alcohol or drug abuse
- Serious dissociative symptoms
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 |
|---|---|---|
| Narrative Exposure TherapyAlso: NETPsychological treatment, with narration of positive and traumatic events in patients history, including "in vivo" exposure of traumatic events. The narrative is written down by the therapist. | Behavioural | A |
Primary outcome
Psychiatric symptoms
Time frame: 1 and 6 months after treatment
1 secondary outcome
Cortisol in saliva
Time frame: 1 and 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2008.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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.
Anne Marita Milde, PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Narrative Exposure Therapy in people with Posttraumatic Stress Disorder, run by University of Bergen 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Apr 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tove S. Nordling, Cand Psychol (+47 55976691, tsno@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric symptoms (time frame: 1 and 6 months after treatment). 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 17 Apr 2008.