NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

April 24, 2017 updated by: Tahere Orang, University of Konstanz

Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)

The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD) and depression and for the improvement of daily functioning in Iranian women who have experienced intimate partner violence (IPV). In addition, the study seeks to investigate whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within their marriage.

Study Overview

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being victims of Intimate Partner Violence and seeking help at target clinics in order to reduce their psychological symptoms, currently living together with their partner/husband, meeting the set cut-off point on the PTSD scale according to DSM-IV.

Exclusion Criteria:

  • schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treamtent-as-usual
Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy.

Treatment-as-usual was defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive counseling.

Regarding supportive counselling, the sessions included:

Life skill education CBT techniques ACT techniques Finding resources to stop violence Discussing marital and sexual conflicts with the presence of husbands Working on their children problems Improvement of communication skills

Experimental: Narrative Exposure Therapy
Narrative Exposure Therapy (NET) is a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy for the treatment of PTSD resulting from organized violence.
Narrative Exposure Therapy (NET) is a treatment approach that was developed by a research group of the University of Konstanz (Schauer, Neuner, & Elbert, 2005, 2011). In NET, the patient repeatedly talks about the most arousing traumatic events in detail while re-experiencing the emotions associated with this event. In the process, the patient constructs a narration of his life, focusing on the detailed report of the traumatic experiences.
Other Names:
  • NET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Diagnostic Scale (PDS/PSS-I).
Time Frame: Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)
The PDS/PSS-I is a 17-item screening instrument on a 4-point-Likert-scale (0 = not at all to 3 = very much). The PDS aims at assessing all Diagnostic and Statistical Manual (DSM-IV) criteria of a Post Traumatic Stress Disorder (PTSD), and thus it includes information about the nature of the traumatic event and the level of functional interference.
Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
The Hopkins Symptom Checklist-25 (HSCL-25)
Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
Perceived Stress Scale-4
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Abuse Scale (CAS)
Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
The CAS, a 30-item validated research instrument, is a widely used self-report questionnaire of behaviors that women describe as abusive by their partners. It is a self-report measure that provides standardized sub scale scores on four dimensions of intimate partner abuse. The four dimensions are Severe Combined Abuse, Emotional Abuse, Physical Abuse, and Harassment, scaled from 0 (never) to 5 (daily) over a period of 12-month.
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
The Work and Social Adjustment Scale (WSAS)
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
The WSAS is a widely used 5-item measure of disability. Its psychometric properties were analyzed and shown in different studies and disorders (Mataix-Cols et al, 2005; Mundt et al, 2002).
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
The Life Events Checklist
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
The Life Events Checklist (LEC) is a brief, 17-item, self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC assesses exposure to 16 events known to potentially result in PTSD or distress and includes one item assessing any other extraordinarily stressful event not captured in the first 16 items.
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
Checklist of family violence
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
This checklist assessing the incidence of domestic violence was developed by Catani (2002) and includes questions on physical abuse, verbal violence, neglect and sexual abuse as well as witnessing intimate partner violence between parents.
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borderline Symptom List (BSL-23)
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
The BSL-23 is a shortened form of the full version of the BSL-95. The self-report questionnaire assesses borderline-specific symptomatology on a five response scale ranging from 0 (not at all) to 4 (very strongly).
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Thomas Elbert, Professor, University of Konstanz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO-10122012-UK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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