NCT00552006

Brief Summary

In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 8, 2011

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

October 31, 2007

Last Update Submit

March 7, 2011

Conditions

Keywords

PTSDTreatmentRandomized Controlled Clinical TrialCombatChild SoldiersDisseminationNarrative Exposure TherapyAfrica

Outcome Measures

Primary Outcomes (1)

  • Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)

    3 months, 6 months and 1 year after completion of treatment

Secondary Outcomes (1)

  • Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ

    3 months, 6 months and 1 year after completion of treatment

Study Arms (3)

NET

EXPERIMENTAL
Behavioral: Narrative Exposure Therapy

AC

ACTIVE COMPARATOR
Behavioral: Academic Counseling

WL

NO INTERVENTION

Waiting list

Interventions

Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.

Also known as: NET
NET

Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction. AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.

Also known as: AC
AC

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
  • member of the group of formerly abducted people or former child soldiers

You may not qualify if:

  • current substance dependence
  • mental retardation
  • psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vivo Counselling Centre

Anaka, Amuru, Uganda

Location

Related Publications (1)

  • Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Frank Neuner, Univ.-Prof. Dr.

    Bielefeld University

    PRINCIPAL INVESTIGATOR
  • Thomas Elbert, Univ.-Prof. Dr.

    University of Konstanz

    PRINCIPAL INVESTIGATOR
  • Verena Ertl, Dipl.-Psych. (MSc)

    Bielefeld University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 8, 2011

Record last verified: 2008-07

Locations