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Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War

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History
# Registration date Revision Id
2 2020-07-27, 1399/05/06 146237
1 2020-07-27, 1399/05/06 144701
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  • Protocol summary

    The research has two groups of control and experimental, factorial and one-way blind (study participants) and simple randomization manually and using the names in the envelope.
    The research has two groups of control and experimental, in parallel and one-way blind (study participants) and simple randomization by computer random code algorithm.
    پژوهش دارای دو گروه کنترل و آزمایشی، به شکل فاکتوریال و یک سویه کور (شرکت کننده‌گان در پژوهش) و تصادفی سازی ساده به شکل دستی و با استفاده از قرار دادن اسامی در پاکت نامه.
    پژوهش دارای دو گروه کنترل و آزمایشی، به شکل موازی و یک سویه کور (شرکت کنندگان در پژوهش) و تصادفی سازی ساده به وسیله الگوريتم كدهاي تصادفي كامپيوتري می‌باشد.

  • General information

    40
    60
    empty
    48
    2020-10-21, 1399/07/30
    2019-10-22, 1398/07/30
    2020-12-20, 1399/09/30
    2019-11-21, 1398/08/30
    empty
    2019-10-22, 1398/07/30
    empty
    2019-11-21, 1398/08/30
    empty
    2020-03-10, 1398/12/20
    empty
    Due to the termination of the disease before the registration of the trial, the exact number of samples is corrected; Also, the groups are assigned by a random computer code algorithm, which is incorrectly expressed in the form of a sealed envelope, and is corrected in this update. Also, the date of illness and the end of the trial have been corrected and stated.
    empty
    به دلیل خاتمه بیمارگیری قبل از ثبت کارآزمایی، تعداد دقیق حجم نمونه اصلاح می‌گردد؛ همچنین نحوه تخصیص گروه‌ها بوسیله الگوریتم کدهای تصادفی کامپیوتری است که به اشتباه به شکل پاکت مهر و موم شده بیان شده است و در این بروز رسانی اصلاح میگردد. همچنین تاریخ بیمارگیری و خاتمه کارآزمایی نیز اصلاح و بیان شده است.
    Not receiving psychotherapy for the past six months
    Depression
    War Trauma
    Not receiving psychotherapy for the past six months
    Depression
    Diagnosis of PTSD based on DSM-5 criteria
    Having at least a high school education
    Age range between 18 and 50 years
    عدم دریافت روان‌درمانی در طی شش ماه گذشته
    افسردگی
    ترومای جنگ
    عدم دریافت روان‌درمانی در طی شش ماه گذشته
    افسردگی
    تشخیص PTSD بر اساس ملاکهای DSM-5
    داشتن تحصیلات حداقل دوره متوسطه
    رده سنی بین 18 تا 50 سال
    War Trauma
    Pathological association with other psychiatric disorders
    Psychotic symptoms
    intellectual disability
    Personality disorders
    ترومای جنگ
    همایندی مرضی با سایر اختلالات روانپزشکی
    علایم سایکوتیک
    ناتوانی ذهنی
    اختلالات شخصیت
    Randomization: Samples will be selected by available method based on inclusion criteria and randomly assigned to experimental and control groups (20 people in each group). The names of the participants are written on small sheets of paper and placed in a closed envelope; The names of the first 20 people to be removed from the envelope are placed in the experimental group and the remaining 20 people are placed in the control group. It should be noted that after the completion of the research, intervention will be done for the control group to observe research ethics.
    Randomization: In this study, to randomly assign participants to two groups of 30, the Random function in MATLAB software was used to generate random numbers between 0 and 1; If the random numbers generated were less than 0.5, the person was placed in the experimental group and if it is more than 0.5, the person was placed in the control group. It should be noted that after the completion of the study, an intervention was made for the control group to observe research ethics.
    تصادفی سازی: نمونه‌ها به روش در دسترس براساس ملاک‌های ورود انتخاب و به روش انتساب تصادفی به دو گروه آزمایشی و کنترل (در هر گروه 20 نفر) تقسیم خواهند شد. اسامی افراد شرکت‌کننده روی برگه‌های کوچک نوشته شده و به شکل سر بسته داخل یک پاکت قرار می‌گیرید؛ اسامی 20 نفر اول که از پاکت خارج شوند در گروه آزمایشی قرار می‌گیرند و 20 نفر باقی مانده در گروه کنترل قرار می‌گیرند. لازم به ذکر است که پس از اتمام پژوهش، برای رعایت اخلاق در پژوهش برای گروه کنترل نیز مداخله صورت خواهد گرفت.
    تصادفی سازی: در این پژوهش، جهت تخصیص تصادفی شرکت کنندگان به دو گروه 30 نفری، از تابع Random در نرم افزار متلب برای تولید اعدا تصادفی بین 0 و 1 استفاده شده است؛ اگر اعداد تصادفی تولید شده کمتر از 0/5 باشد فرد در گروه آزمایش جای می‌گیرد و اگر بیشتر از 0/5 باشد فرد در گروه کنترل قرار می‌گیرد. لازم به ذکر است که پس از اتمام پژوهش، برای رعایت اخلاق در پژوهش برای گروه کنترل نیز مداخله صورت خواهد گرفت.

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: The University of Kurdistan
    Name of organization / entity - Persian: دانشگاه کردستان
    Full name of responsible person - English: Mahdi Zemestani
    Full name of responsible person - Persian: مهدی زمستانی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
    Street address - Persian: ایران، سنندج، بلوار پاسداران، دانشگاه کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۶۶۱۷۷-۱۵۱۷۵
    Phone: 0098 87 33664600-8
    Mobile: +98 912 437 4452
    Fax:
    Email: m.zemestan@gmail.com
    Web page address: https://research.uok.ac.ir/~mzemestani
    contact.organization_id:
    Name of organization / entity - English: The University of Kurdistan
    Name of organization / entity - Persian: دانشگاه کردستان
    Full name of responsible person - English: Mahdi Zemestani
    Full name of responsible person - Persian: مهدی زمستانی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
    Street address - Persian: ایران، سنندج، بلوار پاسداران، دانشگاه کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 66177-15175
    Phone: 0098 87 33664600-8
    Mobile: +98 912 437 4452
    Fax:
    Email: m.zemestan@gmail.com
    Web page address: https://research.uok.ac.ir/~mzemestani

Protocol summary

Study aim
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War
Design
The research has two groups of control and experimental, in parallel and one-way blind (study participants) and simple randomization by computer random code algorithm.
Settings and conduct
The study will be conducted in the Iraqi province of Sulaymaniyah, and the participants in this study will be employed by the Jian Institute for Human Rights. This research will be pre-test-post-test. The research will be conducted with informed written consent, confidentiality of data, freedom to discontinue treatment, non-conflict of interest in clinical research and other important ethical points of research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: PTSD diagnosis based on DSM-5 criteria; Having symptoms of depression; Having at least a high school education; The age range is between 18 and 50 years and no psychotherapy has been received in the last six months. Exclusion criteria: pathological compatibility with other psychiatric disorders; Having psychotic symptoms; intellectual disability; Existence of personality disorders.
Intervention groups
The control group will not receive any intervention; But the experimental group will receive 12 90-minute weekly intervention sessions that are pre-prepared as a protocol.
Main outcome variables
The effect of trauma-focused cognitive-behavioral therapy on symptoms of anxiety, depression, emotion regulation strategies in Sinhala women victims of the Iraq war; Fear, helplessness and panic and quality of life of Shengali women victims of the Iraq war.

General information

Reason for update
Due to the termination of the disease before the registration of the trial, the exact number of samples is corrected; Also, the groups are assigned by a random computer code algorithm, which is incorrectly expressed in the form of a sealed envelope, and is corrected in this update. Also, the date of illness and the end of the trial have been corrected and stated.
Acronym
PTSD
IRCT registration information
IRCT registration number: IRCT20200216046517N1
Registration date: 2020-07-27, 1399/05/06
Registration timing: retrospective

Last update: 2020-08-08, 1399/05/18
Update count: 1
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Reza Didehban
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 25 3887 1052
Email address
reza.didehbann@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-10-22, 1398/07/30
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2020-03-10, 1398/12/20
Scientific title
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War
Public title
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
War Trauma Not receiving psychotherapy for the past six months Depression Diagnosis of PTSD based on DSM-5 criteria Having at least a high school education Age range between 18 and 50 years
Exclusion criteria:
Pathological association with other psychiatric disorders Psychotic symptoms intellectual disability Personality disorders
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: In this study, to randomly assign participants to two groups of 30, the Random function in MATLAB software was used to generate random numbers between 0 and 1; If the random numbers generated were less than 0.5, the person was placed in the experimental group and if it is more than 0.5, the person was placed in the control group. It should be noted that after the completion of the study, an intervention was made for the control group to observe research ethics.
Blinding (investigator's opinion)
Single blinded
Blinding description
One-way blinding: In this study, only participants (subjects) in both experimental and control groups are kept blind and have no information that there are two groups of control and experimental and do not have the type and form of intervention; Also, at each stage of pre-test, post-test and intervention (for the experimental group), they will not be given any additional information about the research. For example, those in the experimental group who have been intervened do not know that they have been intervened and that the class or workshop they are in is the same as the intervention; The control group, like the experimental group, does not know that there is an intervention and completing the questionnaire in the pre-test and post-test is just to collect some information.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Kurdistan (UOK)
Street address
University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷-۱۵۱۷۵
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.UOK.REC.1399.017

Health conditions studied

1

Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
Post-traumatic stress disorder
Timepoint
Before the intervention - after the intervention - one month after the intervention (follow-up)
Method of measurement
Structured Clinical Interview for DSM-5 (SCID-5) - PTSD Checklist-5 - War-Related Trauma - Life Events Checklist - The Patient Health Questionnaire - Difficulties in Emotion Regulation Scale (DERS) - WHOQOL-BREF - The Depression, Anxiety, and Stress Scales with 21 items

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Shengali women victims of the Iraq war. The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Then TF-CBT intervention (including 12 sessions of 90 minutes per week) is performed on one group (experimental group) and therapeutic intervention is not performed on the control group. At the end of the intervention sessions, the research tools in the post-test phase are immediately implemented again for the members of both groups and their scores are compared with their previous scores according to the dependent variables of the research.
Category
Treatment - Other

2

Description
Control group: Shengali women victims of the Iraq war. The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Since no intervention is performed on the control group, after the intervention on the experimental group, post-test is performed on both groups simultaneously. Research tools in the post-test stage are immediately implemented for members of both groups and their scores are compared with their previous scores in terms of research-dependent variables.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jian Institute for Human Rights
Full name of responsible person
Ako Mohammad
Street address
Jian Institute; next to the industrial town, Shoresh, Chamchamal, Soleimaniyeh, Iraq
City
Chamchamal
Postal code
00000000000
Phone
Fax
Email
info@jiyan-foundation.org
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Mahdi Zemestani
Street address
University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 4600
Email
info@uok.ac.ir
Web page address
https://www.uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kurdistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Mahdi Zemestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 4600
Email
m.zemestan@gmail.com
Web page address
https://research.uok.ac.ir/~mzemestani

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Mahdi Zemestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
098 87 33664600-8
Email
m.zemestan@gmail.com
Web page address
https://research.uok.ac.ir/~mzemestani/

Person responsible for updating data

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Mahdi Zemestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
0098 87 33664600-8
Email
m.zemestan@gmail.com
Web page address
https://research.uok.ac.ir/~mzemestani

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All research data
When the data will become available and for how long
Simultaneously with the release
To whom data/document is available
All researchers and enthusiasts
Under which criteria data/document could be used
Only with the permission of researchers
From where data/document is obtainable
The person responsible for the general response of the trial The person responsible for the scientific accountability of the study The person responsible for updating the information
What processes are involved for a request to access data/document
Send request via email
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