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IRCT20260901070856N1 IRCT 2026-10-28 Shahid Beheshti University of Medical Sciences A Randomized Controlled Trial Comparing the Effectiveness of the Unified Protocol (UP) and Metacognitive Therapy (MCT) on Transdiagnostic Variables in Adults with Posttraumatic Stress Disorder (PTSD). A Randomized Controlled Trial Comparing the Effectiveness of the Unified Protocol (UP) and Metacognitive Therapy (MCT) on Transdiagnostic Variables in Adults with Posttraumatic Stress Disorder (PTSD). 2026-09-23 anticipated 62 Recruiting https://irct.ir/trial/92943 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming the eligibility criteria and obtaining written informed consent, eligible participants will be randomly allocated in a 1:1 ratio to either the Unified Protocol (UP) or Metacognitive Therapy (MCT) group. The random allocation sequence will be generated using a computer-based randomization procedure, Blinding description: Single blinding will be used in this study. Due to the nature of psychological interventions, blinding of participants and therapists to the treatment condition is not feasible. However, the data analyst will be blinded to the participants’ group allocation and the type of intervention received. N/A Patients with post-traumatic stress disorder (PTSD). Intervention 1: Intervention Group 1:lThe Unified Protocol (UP) is a process-based approach that targets shared emotional processes across different psychological disorders, particularly in the treatment of co-occurring emotional disorders. This treatment consists of 10 weekly sessions, each lasting 60–90 minutes, and focuses on addressing core mechanisms such as emotional avoidance, emotion dysregulation, and cognitive errors.The session content is structured around eight core components, including enhancing motivation, psychoeducation, emotional awareness, cognitive restructuring, interoceptive and situational exposure, and relapse prevention. Using cognitive-behavioral and exposure-based techniques, therapists aim to modify clients’ maladaptive coping styles and enhance their emotional resilience.This protocol was developed by Barlow and colleagues, and its efficacy has been well documented in populations with post-traumatic stress disorder (PTSD). Intervention 2: Intervention Group 2: Metacognitive TherapyMetacognitive Therapy (MCT) is designed based on the metacognitive model of emotional disorders. Rather than focusing on the content of thoughts, it targets cognitive processing styles and higher-order beliefs about thoughts. The treatment is delivered over 10 weekly sessions, each lasting 60–90 minutes, and employs techniques such as detached mindfulness, disengagement from perseverative thinking, and the cessation of threat monitoring.The primary goal of treatment is to reduce maladaptive coping strategies, including rumination, chronic worry, cognitive avoidance, and thought suppression. In MCT, positive and negative metacognitive beliefs about rumination and PTSD symptoms are challenged, and clients are gradually guided toward healthier cognitive processing styles.This approach has shown promise, particularly in populations whose disorders are characterized by cognitive avoidance and persistent cognitive engagement. Yes - There is a plan to make this available What will be shared: PhD dissertation research proposal entitled “A Randomized Controlled Trial Comparing the Effectiveness of the Unified Protocol (UP) and Metacognitive Therapy (MCT) on Posttraumatic Stress Symptoms and Transdiagnostic Variables in Adults with Posttraumatic Stress Disorder (PTSD).” The document includes the study design, methodology, objectives, hypotheses, study variables, and measurement instruments. When: From the date of research proposal approval until the end of the study implementation period (12 months). To whom: The researcher (PhD student), the supervisor, the consultant, and authorized members of the research team involved in conducting the study. Access to individual participant data will be limited to the purposes of the study and will be subject to confidentiality requirements Conditions: The research documents and data may be used solely for scientific, research, and educational purposes related to the present study and within the approved research objectives. Data use is subject to maintaining participant confidentiality and privacy. Any use of identifiable data, transfer of data to unauthorized individuals, or use beyond the approved research objectives is not permitted. Where to obtain: Requests for access to the research documents or data should be addressed to Bahareh Moradhasel, PhD student in Clinical Psychology and the researcher responsible for the study. Requests will be reviewed and approved by the research supervisor, Dr. Hoda Doos-Alivand, in accordance with confidentiality and research ethics requirements. How to obtain: Requests will be reviewed based on the intended purpose of use, the type of requested data or documents, the applicant’s eligibility, and compliance with ethical and confidentiality requirements. If approved, only the minimum necessary data or documents will be provided, with participants’ identifying information removed or anonymized. Where applicable, access will be subject to confidentiality and restrictions on use beyond the approved purpose. Comments:
public Bahareh Moradhasel
Velenjak,. Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 B.moradhasel@yahoo.com Shahid Beheshti University of Medical Sciences scientific Hoda doos ali vand
Velenjak Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 Doosalivand.h@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of PTSD based on the SCID-5-CV, in accordance with the DSM-5-TR criteria A score above 31 on the PCL-5 No current use of psychiatric medication; if the participant is taking psychiatric medication, the type and dosage of the medication(s) must have remained stable for at least 8 weeks prior to the start of the intervention, with no changes in the type or dosage of medication(s) throughout the study period No concurrent receipt of psychotherapy (individual or group) during the study Provision of written informed consent to participate in the study 18 years 65 years Both Substance and alcohol abuse Presence of a severe psychiatric disorder, such as psychotic disorders or bipolar disorder. The SCID-5-CV will be used to assess psychotic and bipolar disorders. Experiencing suicidal ideation or attempting suicide during treatment Severe cognitive or neurological disorders, such as intellectual disability, dementia, or organic brain disorders, that may interfere with effective participation in the intervention Missing more than two treatment sessions F43.1 Post-traumatic stress disorder (PTSD) Treatment - Other Treatment - Other Intervention Group 1:lThe Unified Protocol (UP) is a process-based approach that targets shared emotional processes across different psychological disorders, particularly in the treatment of co-occurring emotional disorders. This treatment consists of 10 weekly sessions, each lasting 60–90 minutes, and focuses on addressing core mechanisms such as emotional avoidance, emotion dysregulation, and cognitive errors.The session content is structured around eight core components, including enhancing motivation, psychoeducation, emotional awareness, cognitive restructuring, interoceptive and situational exposure, and relapse prevention. Using cognitive-behavioral and exposure-based techniques, therapists aim to modify clients’ maladaptive coping styles and enhance their emotional resilience.This protocol was developed by Barlow and colleagues, and its efficacy has been well documented in populations with post-traumatic stress disorder (PTSD). Intervention Group 2: Metacognitive TherapyMetacognitive Therapy (MCT) is designed based on the metacognitive model of emotional disorders. Rather than focusing on the content of thoughts, it targets cognitive processing styles and higher-order beliefs about thoughts. The treatment is delivered over 10 weekly sessions, each lasting 60–90 minutes, and employs techniques such as detached mindfulness, disengagement from perseverative thinking, and the cessation of threat monitoring.The primary goal of treatment is to reduce maladaptive coping strategies, including rumination, chronic worry, cognitive avoidance, and thought suppression. In MCT, positive and negative metacognitive beliefs about rumination and PTSD symptoms are challenged, and clients are gradually guided toward healthier cognitive processing styles.This approach has shown promise, particularly in populations whose disorders are characterized by cognitive avoidance and persistent cognitive engagement. Symptoms of post-traumatic stress disorder (PTSD). Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: The PTSD Checklist for DSM-5 (PCL-5). Symptoms of depression. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: The Patient Health Questionnaire-9. Symptoms of anxiety. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: A 7-item anxiety scale (GAD-7). Emotion regulation. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: Difficulties in Emotion Regulation Scale(DERS). The intolerance of uncertainty. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: Intolerance of Uncertainty Scale-12 (IUS-12). Quality of Life. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: Assessment of Quality of Life 8 Dimension. Client Satisfaction. Timepoint: Pre-test (before the start of the intervention), post-test (after completion of the tenth week of the intervention), follow-up (three months after completion of the intervention). Method of measurement: Client Satisfaction Questionnaire (CSQ). Shahid Beheshti University of Medical Sciences Approved 2026-08-11 Ethics committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran Velenjak Ave. Tehran Tehran Iran (Islamic Republic of)