Treatment Effects of Narrative Exposure Therapy

NCT ID: NCT00660439

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

PTSD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Treatment group, receives Narrative Exposure Therapy immediately after first assessment. Patients are assessed 1 and 6 months after treatment.

Group Type EXPERIMENTAL

Narrative Exposure Therapy

Intervention Type BEHAVIORAL

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.

B

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Narrative Exposure Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NET

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Posttraumatic Stress Disorder (PTSD)
* Age above 18 years
* Understands, speaks and writes Norwegian
* Informed, written consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian Center for Violence and Traumatic Stress Studies

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Bergen, Department of Biological and Medical Psychology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne Marita Milde, PhD

Role: STUDY_DIRECTOR

University of Bergen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western Norway Violence and Traumatic Stress Resource Centre

Bergen, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tove S. Nordling, Cand Psychol

Role: CONTACT

Phone: +47 55976691

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tove S. Nordling, Cand Psychol

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NET 40

Identifier Type: -

Identifier Source: org_study_id