Trial record 18 of 1013 for:    "mental disorders" [CONDITION] AND child [AGE-GROUP] | Open Studies

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
  Purpose

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.


Condition Intervention
Mental Disorders
Domestic Violence
Behavioral: Narrative Exposure Therapy
Other: Treatment-as-usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731418

Contacts
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

Locations
Iran, Islamic Republic of
Mental Health Clinics Recruiting
Tehran, Iran, Islamic Republic of
Contact: Maryam Rasoulian, Assistant Professor       rasoulian.m@gmail.com   
Sponsors and Collaborators
University of Konstanz
Tehran University of Medical Sciences
Investigators
Study Chair: Thomas Elbert, Professor University of Konstanz
  More Information

No publications provided

Responsible Party: Tahere Orang, PhD Student, University of Konstanz
ClinicalTrials.gov Identifier: NCT01731418     History of Changes
Other Study ID Numbers: TO-10122012-UK
Study First Received: November 15, 2012
Last Updated: April 8, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by University of Konstanz:
Post Traumatic Stress Disorder
Depression
Intimate Partner violence
Narrative Exposure Therapy

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 26, 2014