NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

NCT01731418 | Completed DMC

• 1 other identifier: TO-10122012-UK
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders; Domestic Violence

Keywords

Post Traumatic Stress Disorder; Depression; Intimate Partner violence; Narrative Exposure Therapy

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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

• 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 Outcomes (4)

• Composite Abuse Scale (CAS)

  At pre-treatment-point, post-treatment-point, and 3- and 6-month follow-ups

• The Work and Social Adjustment Scale (WSAS)

  At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

• The Life Events Checklist

  At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

• Checklist of family violence

  At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

Other Outcomes (1)

• Borderline Symptom List (BSL-23)

  At pre-treatment-point, post-treatment-point and 3- and 6-month follow-ups

Study Arms (2)

Treamtent-as-usual

OTHER

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

Narrative Exposure Therapy

EXPERIMENTAL

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

Interventions

Narrative Exposure Therapy BEHAVIORAL

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.

Also known as: NET

Narrative Exposure Therapy

Treatment-as-usual OTHER

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

Treamtent-as-usual

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment

Sponsors & Collaborators

• University of Konstanz: lead
• Tehran University of Medical Sciences: collaborator

Study Sites (1)

Mental Health Clinics

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 32608505 DERIVED

MeSH Terms

Conditions

Mental Disorders; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Thomas Elbert, Professor

  University of Konstanz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

IR (1)