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IRCT20250301064887N3 IRCT 2026-08-10 The University of Mohaghegh Ardabili The Effect of Transdiagnostic Cognitive‑Behavioral Therapy on Improving Posttraumatic Stress Disorder in Veterans 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 2026-09-23 anticipated 60 Pending https://irct.ir/trial/91629 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Post-Traumatic Stress Disorder. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: Access period starts 6 months after results are published. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Sanaz Eyni
Faculty of Humanities and Social Sciences., university of Kurdistan., Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6617715175 +98 87 3366 0077 s.eyni@uok.ac.ir The University of Kurdistan scientific Sanaz Eyni
Faculty of Humanities and Social Sciences., university of Kurdistan., Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 6617715175 +98 87 3366 0077 s.eyni@uok.ac.ir The University of Kurdistan Iran (Islamic Republic of) 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 40 years 60 years Male Current psychotic disorder or substance use disorder Concurrent participation in another form of psychotherapy F43.1 Post-traumatic stress disorder (PTSD) Treatment - Other Treatment - Other 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. 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. 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. 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. 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. 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. 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. 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. The University of Mohaghegh Ardabili Approved 2026-07-01 Research Ethics Committees of University of Mohaghegh Ardabili University of Mohaghegh Ardabili, the end of University Street Ardabil Ardabil Iran (Islamic Republic of)