- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731418
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tehran, Iran, Islamic Republic of
- Mental Health Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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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 |
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)
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The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
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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
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At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
|
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The Hopkins Symptom Checklist-25 (HSCL-25)
Time Frame: At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
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The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
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At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
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Perceived Stress Scale-4
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview
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At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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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.
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At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
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The Work and Social Adjustment Scale (WSAS)
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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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).
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At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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The Life Events Checklist
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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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.
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At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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Checklist of family violence
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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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.
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At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Borderline Symptom List (BSL-23)
Time Frame: At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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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).
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At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Thomas Elbert, Professor, University of Konstanz
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TO-10122012-UK
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