Protocol summary
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Study aim
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Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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PTSD
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IRCT registration information
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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
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Registration date
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2020-07-27, 1399/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-22, 1398/07/30
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Expected recruitment end date
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2019-11-21, 1398/08/30
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Actual recruitment start date
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2019-10-22, 1398/07/30
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Actual recruitment end date
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2019-11-21, 1398/08/30
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Trial completion date
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2020-03-10, 1398/12/20
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Scientific title
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Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War
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Public title
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Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-06, 1399/03/17
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Ethics committee reference number
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IR.UOK.REC.1399.017
Health conditions studied
1
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Description of health condition studied
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Post-traumatic stress disorder
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ICD-10 code
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F43.1
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ICD-10 code description
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Post-traumatic stress disorder (PTSD)
Primary outcomes
1
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Description
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Post-traumatic stress disorder
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Timepoint
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Before the intervention - after the intervention - one month after the intervention (follow-up)
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Method of measurement
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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
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The University of Kurdistan
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All research data
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When the data will become available and for how long
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Simultaneously with the release
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To whom data/document is available
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All researchers and enthusiasts
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Under which criteria data/document could be used
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Only with the permission of researchers
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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Send request via email
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Comments
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