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Completed

NCT Number: NCT01731418

NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

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.

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Key information

Age range

16 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Clinics

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrative Exposure Therapy

Behavioral

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

Treatment-as-usual

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Collaborators

  • Tehran University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2012
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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