Back to resultsNET in Iranian Women Suffering From Post Traumatic Stress Symptoms
Primary Purpose
Mental Disorders, Domestic Violence
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Treatment-as-usual
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Post Traumatic Stress Disorder, Depression, Intimate Partner violence, Narrative Exposure Therapy
Eligibility 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
Sites / Locations
- Mental Health Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Treamtent-as-usual
Narrative Exposure Therapy
Arm Description
Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy.
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.
Outcomes
Primary Outcome Measures
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.
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
The Hopkins Symptom Checklist-25 (HSCL-25)
The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
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
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
NCT ID
NCT01731418
First Posted
November 15, 2012
Last Updated
April 24, 2017
Sponsor
University of Konstanz
Collaborators
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01731418
Brief Title
NET in Iranian Women Suffering From Post Traumatic Stress Symptoms
Official Title
Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Domestic Violence
Keywords
Post Traumatic Stress Disorder, Depression, Intimate Partner violence, Narrative Exposure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treamtent-as-usual
Arm Type
Other
Arm Description
Treatment-as-usual can be defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive psychotherapy.
Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment-as-usual
Intervention Description
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 Outcome Measure Information:
Title
Posttraumatic Diagnostic Scale (PDS/PSS-I).
Description
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.
Time Frame
Symptoms will be assessed at pre-treatment-point and post-treatment-point (up to 6-month follow-ups)
Title
The Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
Title
The Hopkins Symptom Checklist-25 (HSCL-25)
Description
The Hopkins Symptom Checklist 25 would be used to screen for symptoms of depression and anxiety.
Time Frame
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
Title
Perceived Stress Scale-4
Description
The Perceived Stress Scale (PSS) would be used to assess the perception of stress over the course of the last month preceding the interview
Time Frame
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
Secondary Outcome Measure Information:
Title
Composite Abuse Scale (CAS)
Description
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.
Time Frame
At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups
Title
The Work and Social Adjustment Scale (WSAS)
Description
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).
Time Frame
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
Title
The Life Events Checklist
Description
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.
Time Frame
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
Title
Checklist of family violence
Description
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.
Time Frame
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
Other Pre-specified Outcome Measures:
Title
Borderline Symptom List (BSL-23)
Description
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).
Time Frame
At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Elbert, Professor
Organizational Affiliation
University of Konstanz
Official's Role
Study Chair
Facility Information:
Facility Name
Mental Health Clinics
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32608505
Citation
Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
Results Reference
derived
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NET in Iranian Women Suffering From Post Traumatic Stress Symptoms
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