NCT00563888

Brief Summary

Effective Treatment of PTSD involves talking about the traumatic event in detail.It is unclear how this process influences the sensory-specific trauma network (fear structure)in the traumatized person. The goal of the project is to test the hypothesis that treatment-facilitated recovery does not change the original fear structure but establishes an inhibitory mechanism that depends on verbal activity. An affective visual steady-state paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli will be used to examine the spatial and temporal pattern of the processing of emotional stimuli. To examine the effects of treatment this paradigm will be used as outcome measure within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control condition for severely traumatized torture victims.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

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

January 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 26, 2007

Status Verified

November 1, 2007

First QC Date

November 23, 2007

Last Update Submit

November 23, 2007

Conditions

PTSD

Keywords

PTSDtorture survivorsNarrative Exposure Therapytrauma-related memory processessteady state visual evoked fields

Outcome Measures

Primary Outcomes (1)

  • PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS)

    4 & 9 months after completion of treatment

Secondary Outcomes (1)

  • steady state visual evoked magnetic fields in response to affective stimuli

    4 & 9 months after completion of treatment

Study Arms (2)

A

EXPERIMENTAL

Narrative Exposure Therapy (NET)

Behavioral: NET

B

NO INTERVENTION

Waitinglist Control Group

Interventions

NETBEHAVIORAL

Narrative Exposure Therapy for traumatized survivors of organized violence

A

Eligibility Criteria

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

You may qualify if:

  • experiences of organized violence/torture
  • PTSD diagnosis

You may not qualify if:

  • psychotic disorder
  • neurological disease or seizures
  • current drug/alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Department of Psychology

Konstanz, 78467, Germany

Location

Related Publications (2)

  • Adenauer H, Catani C, Gola H, Keil J, Ruf M, Schauer M, Neuner F. Narrative exposure therapy for PTSD increases top-down processing of aversive stimuli--evidence from a randomized controlled treatment trial. BMC Neurosci. 2011 Dec 19;12:127. doi: 10.1186/1471-2202-12-127.

    PMID: 22182346DERIVED

  • Adenauer H, Pinosch S, Catani C, Gola H, Keil J, Kissler J, Neuner F. Early processing of threat cues in posttraumatic stress disorder-evidence for a cortical vigilance-avoidance reaction. Biol Psychiatry. 2010 Sep 1;68(5):451-8. doi: 10.1016/j.biopsych.2010.05.015.

    PMID: 20619396DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Claudia Catani, Dr.

    University of Konstanz

    STUDY DIRECTOR

  • Frank Neuner, Prof.

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2007

First Posted

November 26, 2007

Study Start

January 1, 2007

Study Completion

December 1, 2008

Last Updated

November 26, 2007

Record last verified: 2007-11

Locations

DE(1)