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, factorial and one-way blind (study participants) and simple randomization manually and using the names in the envelope.
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
Acronym
PTSD
IRCT registration information
IRCT registration number:IRCT20200216046517N1
Registration date:2020-07-27, 1399/05/06
Registration timing:prospective
Last update:2020-07-27, 1399/05/06
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
2020-10-21, 1399/07/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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:
Not receiving psychotherapy for the past six months
Depression
Exclusion criteria:
War Trauma
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
۶۶۱۷۷-۱۵۱۷۵
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