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). I n addition, the study seeks to investigate whether NET therapy could lead to the reduction of IPV within their marriage.
The study design consists of two groups, one receiving “Narrative Exposure Therapy”, and the other one being treated with the treatment-as-usual. Treatment-as-usual can be defined as the commonly used therapy type for abused women in Iran, such as medical therapy and/or supportive psychotherapy.
The researcher will meet the participants referred to the target clinic by other research colleagues, clinical therapists and psychiatrists, and will invite them to participate in the study and to sign the informed consent form. The researcher will then ask the participants to complete the questionnaires and to participate in diagnostic interviews in a 2-3-hour session. Upon obtaining a minimum score of 15 in the PSSI-structured interview, these women are randomly allocated to either the treatment-as-usual group or the NET group. The participants will be invited to complete the necessary questionnaires and take part in interviews in 3- and 6-month follow-ups.
The total number of two treatment groups is 40, and it is estimated that it will take 2 years to complete the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050313211N1
Registration date:2013-05-29, 1392/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Maryam Rasoulian
Name of organization / entity
Mental Health Research Network
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9024
Email address
rasoulian-m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mental Health Research Network (Tehran Psychiatric Institute)
Tahere Orang (the researcher)
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Narrative Exposure Therapy (NET) in a Sample of Iranian Women Exposed to Intimate Partner Violence (IPV)
-A randomized trial-
Public title
The treatment of mental disorders in women exposed to domestic violence
Purpose
Treatment
Inclusion/Exclusion criteria
Within this treatment study women being victims of Intimate Partner Violence and seeking help at target clinics in order to reduce their psychological symptoms, should be invited to take part in the proposed study. Only women currently living together with their partner/husband and aged between 16 and 60 years will be included. Also, the women taking part in the study should meet the set cut-off point on the PTSD scale according to DSM-IV. Women, suffering from schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment will be excluded.
Age
From 16 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials
Secondary trial Id
TO-10122012-UK
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mental Health Research Network, Tehran Psychiatric Institute
Street address
Sattar khan ST, Niyayesh ST, Mansouri alley, Tehran Psychiatric Institute
City
Tehran
Postal code
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
20633
Health conditions studied
1
Description of health condition studied
Post-Traumatic Stress Disorder
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-Traumatic Stress Disorder
Timepoint
Pre- and Post Treatment, 3 and 6 follow-ups
Method of measurement
The interview format of Posttraumatic Diagnostic Scale (PSS-I)
2
Description
Depression
Timepoint
Pre- and Post Treatment, 3 and 6 follow-ups
Method of measurement
The Patient Health Questionnaire (PHQ-9)
3
Description
Depression and Anxiety
Timepoint
Pre- and Post Treatment, 3 and 6 follow-ups
Method of measurement
The Hopkins Symptom Checklist 25
4
Description
the perception of stress
Timepoint
Pre- and Post Treatment, 3- and 6-month follow-ups
Method of measurement
Perceived Stress Scale-10
Secondary outcomes
1
Description
Intimate Partner Violence
Timepoint
Pre- and post treatment, 3- and 6-month follow-ups
Method of measurement
Composite Abuse Scale (CAS)
2
Description
The Work and Social Adjustment
Timepoint
Pre- and post treatment, 3- and 6-month follow-ups
Method of measurement
The Work and Social Adjustment Scale
3
Description
Borderline Symptoms
Timepoint
Pre- and post treatment, 3- and 6-month follow-ups
Method of measurement
Borderline Symptom List (BSL-23)
4
Description
The Life Events Checklist
Timepoint
Pre- and post treatment, 3- and 6-month follow-ups
Narrative Exposure Therapy (NET). NET is a treatment approach that was developed for the treatment of PTSD resulting from organized violence. NET was developed by a research group of the University of Konstanz (Schauer, Neuner, & Elbert, 2005, 2011) as a standardized short-term approach based on the principles of cognitive behavioral exposure therapy and testimony therapy by adapting it to meet the needs of traumatized survivors of war and torture. 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. The majority of people habituates and loses the emotional response to the traumatic memory, which consequently leads to a remission of PTSD symptoms. Also, by using NET we are able to carefully step forward through the complete biography of our patients’ lives in chronological order. In telling the story, the patient is exposed to the sensory information that accompanies the memory and to the image of the events themselves. The patient actually triggers his or her own fear network in the telling by narrating the fragments throughout the course of therapy and he or she is able to reweave the events back into a cool-system framework controlling the triggers present with the hot memories. As a result, the accompanying anxiety, which evolved from the strangeness of dissociative fragments, is defused. All somatosensory percepts (physical sensations), cognitions (thoughts), and emotions relevant to the fear network and involved in the traumatic sequences of memory will be comprehensively uncovered in detail as the narrative unfolds. The course of events is established (in time and place), labeled and transferred into speech until a meaningful and consistent narrative is reached. All traumatic events are revisited until their horrifying impact dissolves. In other words, NET focuses on both the habituation of emotional responses to the memories of the traumatic events and on the construction of a detailed narrative of the events and their consequences. A general guideline for the organization of sessions can be outlined as follows; Session 1: Diagnosis and psycho-education. Session 2: lifeline exercise beginning with the birth and ending with the future in order to define and locate traumatic and non-traumatic events. Session 3: Exposure to most pressing traumatic event. Subsequent sessions: (Re) reading of the narrative collected in previous sessions and continuing the narration/exposure of subsequent traumatic life events. Final session: Rereading and handing-over of the complete narration. The women in the NET group will go to the clinic once a week, and will have total of 6-8 these sessions. In addition, in accordance with the NET manual, at the end of each session, a written account of what is told throughout the session is composed by the therapist, which will be read to the client at the beginning of the next session for her approval of the content of the account. Upon completion of the treatment, a brief biography of the client and her traumatic and non-traumatic experiences which she has told will be given to her.
Category
Other
2
Description
Treatment-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. After participants are randomly allocated to the treatment-as-usual group, the researcher will ask the therapists of this group to write a summary report of the treatment procedure after each session and submit it to the researcher. Thus, the researcher will be supervising the procedures of the treatment-as-usual sessions and will record the treatment procedure.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in south of Theran
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Health centers in west of Theran
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Health centers in city of Rey
Full name of responsible person
Street address
City
Rey
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mental Health Research Network
Full name of responsible person
Dr. Maryam Rasoulian
Street address
Sattar khan ST, Niyayesh ST, Mansouri Alley
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Network
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Tahere Orang
Full name of responsible person
Tahere Orang
Street address
Koohsar ST, Sardar ST, Sardar Alley, Number 5
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tahere Orang
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mental Health Research Network
Full name of responsible person
Tahere Orang
Position
Master
Other areas of specialty/work
Street address
Koohsar ST, Sardar ST, Sardar Alley, Number 5
City
Tehran
Postal code
Phone
+98 21 4430 7915
Fax
Email
minaorang@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mental Health Research Network
Full name of responsible person
Tahere Orang
Position
Master
Other areas of specialty/work
Street address
Koohsar ST, Sardar ST, Sardar Alley, Number 5
City
Tehran
Postal code
Phone
+98 21 4430 7915
Fax
Email
minaorang@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mental Health Research Network
Full name of responsible person
Tahere Orang
Position
Master
Other areas of specialty/work
Street address
Koohsar ST, Sardar ST, Sardar Alley, Number 5
City
Tehran
Postal code
Phone
+98 21 4430 7915
Fax
Email
minaorang@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)