NCT00717548

Brief Summary

The purpose of this study is to perform an evaluation of a trauma-focused short-term intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. \& Elbert, T.) on a variety of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women after sexual exploitation and women trafficking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 5, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

July 15, 2008

Last Update Submit

November 2, 2012

Conditions

Posttraumatic Stress DisorderDepressionDissociation

Keywords

Somatic Complaints

Outcome Measures

Primary Outcomes (1)

  • PTSD, Depression, Somatic Complaints, Dissociation

    Pre-Test, 4-weeks-Post-Test, 6-months-follow-up

Study Arms (1)

A

EXPERIMENTAL
Behavioral: Narrative Exposure Therapy

Interventions

Narrative Exposure TherapyBEHAVIORAL

Trauma-Focused short term intervention (8-12 sessions)

A

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sexual Exploitation or Women Trafficked or Forced Prostitution
  • Symptoms of Post Traumatic Stress Disorder

You may not qualify if:

  • Current Psychotic Symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and Psychological Outpatient Clinic, University of Konstanz, Center for Psychiatry, House 22

Konstanz, 78479, Germany

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionDissociative Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 15, 2008

First Posted

July 17, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

July 1, 2011

Last Updated

November 5, 2012

Record last verified: 2012-11

Locations

DE(1)