NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731418
• Other study ID #: TO-10122012-UK
• Status: Completed
• Phase: N/A
• First received: November 15, 2012
• Last updated: April 24, 2017
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence
• Mental Disorders
• Psychotic Disorders

Intervention

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:
• Treatment-as-usual
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mental Health Clinics	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Borderline Symptom List (BSL-23)	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
Primary	Posttraumatic Diagnostic Scale (PDS/PSS-I).	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)
Primary	The Patient Health Questionnaire-9 (PHQ-9)	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
Primary	The Hopkins Symptom Checklist-25 (HSCL-25)	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
Primary	Perceived Stress Scale-4	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	Composite Abuse Scale (CAS)	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
Secondary	The Work and Social Adjustment Scale (WSAS)	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
Secondary	The Life Events Checklist	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
Secondary	Checklist of family violence	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