NCT00660439

Brief 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 Therapy than the Waiting list (i.e. no intervention).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2.6 years

First QC Date

April 10, 2008

Last Update Submit

April 15, 2008

Conditions

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

  • Psychiatric symptoms

    1 and 6 months after treatment

Secondary Outcomes (1)

  • Cortisol in saliva

    1 and 6 months after treatment

Study Arms (2)

A

EXPERIMENTAL

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

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.

Interventions

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.

Also known as: NET
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway Violence and Traumatic Stress Resource Centre

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Anne Marita Milde, PhD

    University of Bergen

    STUDY DIRECTOR

Central Study Contacts

Tove S. Nordling, Cand Psychol

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 17, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

November 1, 2010

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations