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NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Konstanz
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Tahere Orang, University of Konstanz
ClinicalTrials.gov Identifier:
NCT01731418
First received: November 15, 2012
Last updated: April 8, 2013
Last verified: November 2012

November 15, 2012
April 8, 2013
November 2012
December 2014   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: No ]
    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.
  • The Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    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
  • The Hopkins Symptom Checklist-25 (HSCL-25) [ Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
  • Perceived Stress Scale-4 [ Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview
Same as current
Complete list of historical versions of study NCT01731418 on ClinicalTrials.gov Archive Site
  • Composite Abuse Scale (CAS) [ Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    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.
  • The Work and Social Adjustment Scale (WSAS) [ Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    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).
  • The Life Events Checklist [ Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    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.
  • Checklist of family violence [ Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
    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.
Same as current
Borderline Symptom List (BSL-23) [ Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
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).
Same as current
 
NET in Iranian Women Suffering From Post Traumatic Stress Symptoms
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mental Disorders
  • Domestic Violence
  • Behavioral: Narrative Exposure Therapy
    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 Name: NET
  • Other: Treatment-as-usual
  • 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.
    Intervention: Other: Treatment-as-usual
  • 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.
    Intervention: Behavioral: Narrative Exposure Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
16 Years to 60 Years
Yes
Contact: Tahere Orang, PhD Student (98) 912.670.0427 minaorang@gmail.com
Contact: Thomas Elbert, Full Professor +49 7531 88-4609 thomas.elbert@uni-konstanz.de
Iran, Islamic Republic of
 
NCT01731418
TO-10122012-UK
Yes
Tahere Orang, University of Konstanz
University of Konstanz
Tehran University of Medical Sciences
Study Chair: Thomas Elbert, Professor University of Konstanz
University of Konstanz
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP