"The effectiveness of Prolonged Exposure Therapy for Post-Traumatic Stress Disorder (PTSD) in reducing symptoms and improving the quality of life of veterans and combatants of the Eight-Year Iran-Iraq War."
Determining the Effectiveness of Prolonged Exposure (PE) Therapy in Reducing Symptoms of Post-Traumatic Stress Disorder (PTSD) and Improving Quality of Life among Veterans of the Eight-Year Iran–Iraq War in Ardabil Province
Design
The study includes 3 individuals with post-traumatic stress disorder (PTSD) selected from the research population through purposive sampling.
Settings and conduct
With the introduction of the provincial deputy and research officer to the command of the military unit, the intervention site will be located in the Basirat building in the health section of the study unit.
Participants/Inclusion and exclusion criteria
Active-duty or retired military personnel with a history of war-related trauma.
Having war-related Post-Traumatic Stress Disorder (PTSD) with a medical record and currently under pharmacological treatment.
No history of receiving psychological treatments prior to entering the study.
Ability to read and write.
Patient’s consent to participate in the study and signing the written informed consent form.
Suffering from other major psychiatric disorders (excluding PTSD and comorbid symptoms of depression and anxiety), such as personality disorders, psychotic disorders, or substance and alcohol addiction.
Having suicidal thoughts.
Possessing non-therapeutic motivations (e.g., seeking secondary gains such as increasing disability benefits).
Presence of severe medical conditions or physical injuries, such as spinal cord
Intervention groups
The treatment sessions are 12 sessions, weekly or twice a week, each session usually lasting 90 minutes, and the duration of treatment for each client will be 2 to 4 months. It will be conducted individually based on the PE Prolonged Exposure Therapy (PE) protocol for PTSD developed by Foa et al.
Main outcome variables
Symptoms of Post-Traumatic Stress Disorder (PTSD).
Quality of Life.
General information
Reason for update
Acronym
PET
IRCT registration information
IRCT registration number:IRCT20250806066778N1
Registration date:2025-09-16, 1404/06/25
Registration timing:prospective
Last update:2025-09-16, 1404/06/25
Update count:0
Registration date
2025-09-16, 1404/06/25
Registrant information
Name
Mohammad Amiri
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 914 781 1797
Email address
amiri100370@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The effectiveness of Prolonged Exposure Therapy for Post-Traumatic Stress Disorder (PTSD) in reducing symptoms and improving the quality of life of veterans and combatants of the Eight-Year Iran-Iraq War."
Public title
Evaluating the Effectiveness of Prolonged Exposure Therapy for Post-Traumatic Stress Disorder (PTSD) in Reducing Symptoms and Improving Quality of Life among Veterans of the Iran–Iraq War
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Active-duty or retired military personnel with a history of war-related trauma.
Having war-related Post-Traumatic Stress Disorder (PTSD) with a medical record and currently under pharmacological treatment.
No history of receiving psychological treatments prior to entering the study.
Ability to read and write.
Patient’s consent to participate in the study and signing the written informed consent form.
Exclusion criteria:
Suffering from other major psychiatric disorders (excluding PTSD and comorbid symptoms of depression and anxiety), such as personality disorders, psychotic disorders, or substance and alcohol addiction.
Having suicidal thoughts.
Possessing non-therapeutic motivations (e.g., seeking secondary gains such as increasing disability benefits).
Presence of severe medical conditions or physical injuries, such as spinal cord lesions, that would cause significant difficulties for the patient’s attendance in therapy sessions.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
5
The intervention will be conducted individually, based on the Prolonged Exposure (PE) therapy protocol for Post-Traumatic Stress Disorder (PTSD) developed by Foa and colleagues, and will be administered by the researcher.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group of the Research Ethics Committee of the University of Tabriz
Street address
Tabriz, Oruj Square, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2025-07-22, 1404/04/31
Ethics committee reference number
IR.TABRIZU.REC.1404.078
Health conditions studied
1
Description of health condition studied
Post-Traumatic Stress Disorder – PTSD
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage improvement (Scruggs and Mastropiri, 1998) in single-subject research designs is one of the quantitative indicators for measuring the effectiveness of interventions, which shows the amount of change in behavior or the dependent variable as a percentage compared to the baseline situation.
Timepoint
Effect size in single-subject research designs is a quantitative indicator used to measure the extent to which an intervention has an effect on the dependent treatment (the behavior or outcome under study) and is strength or change.
Method of measurement
In the present study, the 17-item version of the Posttraumatic Stress Symptoms Scale (interview form) developed by Foa, Riggs, Danko, and Rothiam (1993) will be used.
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the World Health Organization's 26-item short form of the Quality of Life Questionnaire (WHO-QOL-BREF) was used. The 17-item version of the Posttraumatic Stress Disorder Scale (interview form) developed by Foa, Riggs, Danko, and Rothiam (1993) will be used.An information session, and obtaining written consent and answers to possible questions from participants, 12 treatment sessions, which are weekly or twice a week, with each session usually lasting 90 minutes.No medication will be used in the treatment. The psychotherapy process is based on 4 important components of long-term exposure, namely psychoeducation, visual exposure, real exposure, and emotional processing, based on the treatment protocol presented by Foa et al.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
military unit
Full name of responsible person
Mohammad Amiri
Street address
Daneshgah Street, Daneshgah Square, Ardabil University of Medical Sciences, Central Headquarters
City
Ardabil
Province
Ardabil
Postal code
5615871897
Phone
+98 914 451 1797
Email
amiri100370@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tabriz
Full name of responsible person
Professor Abbas Bakhshipour
Street address
Tabriz, 29 Bahman Boulevard, University
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
bakhshipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
I have no financial resources
Proportion provided by this source
1
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
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Head of the Student Counseling and Mental Health Department at Ardabil University of Medical Science
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Daneshgah Street, Daneshgah Square, Ardabil University of Medical Sciences Headquarters
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3353 4722
Email
amiri100370@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Professor Abbas Bakhshipour
Position
Full Professor, University of Tabriz
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tabriz, 29 Bahman Boulevard, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Fax
+98 41 3334 0081
Email
bakhshipour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Head of the Student Counseling and Mental Health Department at Ardabil University of Medical Science
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Daneshgah Street, Daneshgah Square, Ardabil University of Medical Sciences Headquarters
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Stress is one of the factors threatening mental health and was one of the consequences of the eight-year Sacred Defense war in Iran. As research has shown, even more than forty years after the end of the war, many veterans or combatants (disabled war veterans) still suffer from post-traumatic stress disorder (PTSD). The most common symptoms among them are increased arousal and reactivity. Therefore, paying attention to this issue is still necessary and there is more work to be done.
When the data will become available and for how long
The preliminary studies for this project started in 2023 and, God willing, will be available by mid-2026.
To whom data/document is available
Respected university professors and those who want to provide services to the warriors and veterans of the eight years of sacred defense
Under which criteria data/document could be used
If the intended goals are to help improve the quality of life of veterans and fighters of the eight years of sacred defense.
From where data/document is obtainable
Website of the Vice Chancellor for Research and Research Technology of Ardabil University of Medical Sciences
What processes are involved for a request to access data/document
By visiting the website of the Vice President for Research and Research Technology of Ardabil University of Medical Sciences