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Moderating Effects of Trauma Severity and Comorbid Major Depression on the Efficacy of Transdiagnostic Cognitive‑Behavioral Therapy for Clinical Symptoms and Emotional Indicators in Veterans with Posttraumatic Stress Disorder: A Randomized Controlled Trial

Protocol summary

Study aim
The aim of this study was to determine the effectiveness of transdiagnostic cognitive-behavioral therapy (TD-CBT) on the clinical symptoms and emotional indices of veterans with post-traumatic stress disorder (PTSD), while examining the moderating roles of trauma severity and comorbid major depressive disorder (MDD).
Design
A controlled clinical trial, with parallel groups, unblinded and randomized.
Settings and conduct
The study will be conducted at Isar Psychiatric Hospital in Ardabil without a placebo, and blinding will be done on the participants and the person who will assess the outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a diagnosis of PTSD established by a psychiatrist using the Structured Clinical Interview for DSM-5 (SCID-5); a score greater than 33 on the PTSD Checklist for DSM-5 (PCL-5); and stable psychotropic medication use during the preceding three months. Exclusion criteria: the presence of active psychosis, substance use, or concurrent participation in another form of psychotherapy.
Intervention groups
Transdiagnostic cognitive-behavioral therapy (CBT) is recognized as a transdiagnostic intervention that targets dimensional constructs and shared processes underlying emotional disorders. In this study, male veterans with post-traumatic stress disorder (PTSD) will be randomly assigned to either an intervention group or a control group. The intervention group will then receive transdiagnostic cognitive-behavioral therapy in 8–10 sessions, each lasting 90 minutes, delivered twice weekly under the supervision of a trained therapist, whereas the control group will receive no intervention. Following the intervention, both groups will undergo post-treatment assessments as well as 3-month and 6-month follow-up evaluations.
Main outcome variables
Trauma severity; major depression; emotion regulation; experiential avoidance and emotional reactivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250301064887N3
Registration date: 2026-08-10, 1405/05/19
Registration timing: prospective

Last update: 2026-08-10, 1405/05/19
Update count: 0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
Soran Khataie
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3372 4155
Email address
soran.khataie@uok.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2027-06-21, 1406/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Moderating Effects of Trauma Severity and Comorbid Major Depression on the Efficacy of Transdiagnostic Cognitive‑Behavioral Therapy for Clinical Symptoms and Emotional Indicators in Veterans with Posttraumatic Stress Disorder: A Randomized Controlled Trial
Public title
The Effect of Transdiagnostic Cognitive‑Behavioral Therapy on Improving Posttraumatic Stress Disorder in Veterans
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A diagnosis of PTSD established by a psychiatrist based on the Structured Clinical Interview for DSM-5 (SCID-5) A score greater than 33 on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Stable psychotropic medication use during the previous three months Provision of written informed consent to participate in the treatment sessions
Exclusion criteria:
Current psychotic disorder or substance use disorder Concurrent participation in another form of psychotherapy
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed using the online Sealed Envelope randomization service. Given the total sample size of 60 participants and the presence of two study arms (intervention and control), block sizes will be selected as multiples of two (i.e., blocks of 2 and 4). Based on the generated randomization sequence and the predefined allocation codes, participants will be assigned to either the intervention group (A) or the control group (B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will employ a double-blind design, in which both the participants and the outcome assessors will be blinded to study group allocation. Participants will not be informed of their assigned treatment group and will receive only general information regarding the overall objectives of the study. Likewise, the outcome assessors will remain blinded to group allocation throughout the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of University of Mohaghegh Ardabili
Street address
University of Mohaghegh Ardabili, the end of University Street
City
Ardabil
Province
Ardabil
Postal code
1313156199
Approval date
2026-07-01, 1405/04/10
Ethics committee reference number
IR.UMA.REC.1405.025

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 score
Timepoint
Measuring the post-traumatic stress disorder before the intervention, after the intervention, three and six months after the end of the intervention
Method of measurement
Post-traumatic stress disorder scale

2

Description
Major depression score
Timepoint
Measurement of major depression before the intervention, after the intervention, three and six months after the end of the intervention
Method of measurement
Beck depression inventory

3

Description
Trauma severity score
Timepoint
Measurement of trauma severity before intervention, after intervention, three and six months after the end of intervention
Method of measurement
Harvard trauma questionnaire

Secondary outcomes

1

Description
Emotion regulation score
Timepoint
Measurement of emotion regulation before the intervention, after the intervention, three and six months after the end of the intervention
Method of measurement
Difficulties in emotion regulation scale

2

Description
Experiential avoidance score
Timepoint
Measurement of experiential avoidance before the intervention, after the intervention, three and six months after the end of the intervention
Method of measurement
Acceptance and action questionnaire

3

Description
Emotional reactivity score
Timepoint
Measurement of emotional reactivity before the intervention, after the intervention, three and six months after the end of the intervention
Method of measurement
Emotional reactivity scale

Intervention groups

1

Description
Intervention group: transdiagnostic cognitive-behavioral therapy. For this group, the transdiagnostic cognitive-behavioral therapy of Barlow et al. (2017) will be used. This intervention will include 10 individual treatment sessions, each of which will last 90 minutes. Specifically, the goal of this protocol is reducing the intensity and frequency of negative emotions. Unified protocol is designed to accomplish this goal through emotion-focused education, awareness techniques, cognitive strategies, problem-solving and an array of behavioral strategies, including a full-range of exposure and activation techniques.
Category
Treatment - Other

2

Description
Control group: The group awaiting transdiagnostic cognitive-behavioral therapy. After the intervention group sessions are completed, transdiagnostic cognitive-behavioral therapy will be implemented as in intervention group number one.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isar psychiatric specialty hospital, Ardabil
Full name of responsible person
Mohammad Narimani
Street address
Isar Psychiatric Specialty Hospital, Ataei Street, Next to Shorabil Recreational Complex
City
Aradabil
Province
Ardabil
Postal code
۵۶۱۹۹۱۱۳۶۷
Phone
+98 45 3351 1508
Email
narimani@uma.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Mohtasham Mohebbi
Street address
University of Mohaghegh Ardabili, University Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۹۹۱۱۳۶۷
Phone
+98 45 3150 5000
Email
mohebbi@uma.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 Mohaghegh Ardabili
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
Sanaz Eyni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities and Social Sciences., university of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 0077
Email
s.eyni@uok.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Sanaz Eyni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities and Social Sciences., university of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 0077
Email
s.eyni@uok.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Sanaz Eyni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities and Social Sciences., university of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 0077
Email
s.eyni@uok.ac.ir

Sharing plan

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In general, personal information about participants' data is not shared. Rather, some of the information related to the main outcome of the study, namely the results of the participants' statistical data, is published.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
In general, researchers working in academic and scientific institutions, students, and professors are allowed to apply, and others are also allowed to apply, provided that ethical considerations are observed.
Under which criteria data/document could be used
In general, scientific research documentation is provided to university employees, professors, and students for the exchange of scientific information, but personal data is not provided to others due to compliance with professional ethics in research and non-abuse.
From where data/document is obtainable
Applicants must contact the researcher via email to receive documents and data. Researcher's details and email address" First and last name: Sanaz Eyni Email address: s.eyni@uok.ac.ir
What processes are involved for a request to access data/document
First, the applicant must send an email to the researcher, and depending on the applicant's circumstances, a scientific commitment letter is obtained from the applicant to comply with professional ethics and avoid abuse, and then the research documentation and data are provided to the applicant.
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