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IRCT20260421069122N1 IRCT 2026-07-06 Shahid Beheshti University of Medical Sciences Comparison of the Effectiveness of MiCBT and ERP in Individuals with Obsessive-Compulsive Disorder with a History of Childhood Maltreatment MiCBT, ERP Comparison of the Effectiveness of Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) and Exposure and Response Prevention (ERP) in Individuals with Obsessive-Compulsive Disorder with a History of Childhood Maltreatment 2026-08-22 anticipated 62 Recruiting https://irct.ir/trial/89557 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was employed. Randomization was performed using a random number table. For each participant, a random number between 0 and 1 was generated. Participants with random values greater than or equal to 0.5 were assigned to the Mindfulness-Integrated Cognitive Behavioral Therapy (MiCBT) group, whereas those with random values less than 0.5 were assigned to the Exposure and Response Prevention (ERP) group, Blinding description: Participants and the statistical analyst will be blinded to the intervention conditions. Participants will not be informed about the specific type of intervention they receive, and the analyst responsible for data analysis will have no knowledge of group allocation. N/A Obsessive-compulsive disorder. Intervention 1: Intervention group: Mindfulness integrated of cognitive behavioral therapy. Participants will participate in ten structured 60- to 90-minute MICBT sessions, conducted according to the standard Bruno Cayon protocol. It emphasizes components such as improving emotion regulation, enhancing cognitive flexibility and mindfulness, and reducing avoidance of situations that trigger obsessive thoughts and compulsive behaviors. Intervention 2: Intervention group: Exposure and Response Prevention (ERP) therapy will be administered in twelve 60-90 minute sessions based on the standard Edna Foa protocol.. This intervention focuses on gradual exposure to obsession-triggering stimuli and prevention of compulsive responses to reduce anxiety and obsessive-compulsive symptoms. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals, including the following: 1. Demographic data; 2. Data related to independent and dependent variables at pre-test, post-test, and follow-up. When: Start of access period before results are printed To whom: No restrictions Conditions: Writing and publishing articles based on the data from this study is not permitted. Where to obtain: Send your request to farnazdoostdari@gmail.com. 2. Visit the OSF.io website. How to obtain: The data is available online at the mentioned site. Comments:
public Farnaz Doostdari
Unit 7, No. 29, Mosivand Alley, Qazvin Street
Tehran Iran (Islamic Republic of) 1333983181 +98 21 2243 9945 f.doostdari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hoda Doos Alivand
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 23871 doosalivand.h@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Aged 18 to 65 years Providing written informed consent to participate in the study A diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5-TR criteria, established using the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV) A history of childhood maltreatment, defined as obtaining a score in the moderate-to-severe range on at least one subscale of the Childhood Trauma Questionnaire (CTQ) For participants receiving pharmacotherapy, maintaining a stable medication regimen for at least four weeks before the intervention and throughout the study period, with no changes in medication type or dosage 18 years 65 years Both Inability to read and write Receiving concurrent psychotherapy (individual or group therapy) during the study period Severe cognitive or neurological disorders (e.g., intellectual disability, dementia, or organic brain disorders) that preclude meaningful participation in the intervention. Diagnosis of severe psychiatric disorders (e.g., psychotic disorders or bipolar disorder) based on the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV). Emergence of suicidal ideation or a suicide attempt during the course of treatment. Substance and alcohol abuse or dependence. F42 Obsessive-Compulsive Disorder (OCD) Treatment - Other Treatment - Other Intervention group: Mindfulness integrated of cognitive behavioral therapy. Participants will participate in ten structured 60- to 90-minute MICBT sessions, conducted according to the standard Bruno Cayon protocol. It emphasizes components such as improving emotion regulation, enhancing cognitive flexibility and mindfulness, and reducing avoidance of situations that trigger obsessive thoughts and compulsive behaviors Intervention group: Exposure and Response Prevention (ERP) therapy will be administered in twelve 60-90 minute sessions based on the standard Edna Foa protocol.. This intervention focuses on gradual exposure to obsession-triggering stimuli and prevention of compulsive responses to reduce anxiety and obsessive-compulsive symptoms. Severity of obsessive-compulsive symptom. Timepoint: Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention. Method of measurement: Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Emotion dysregulation. Timepoint: Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention. Method of measurement: Difficulties in Emotion Regulation Scale–Short Form (DERS-SF). Obsessive beliefs. Timepoint: Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention. Method of measurement: Short Form of Obsessive Beliefs Questionnaire (OBQ-20). Experiential Avoidance. Timepoint: Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention. Method of measurement: Acceptance and Action Questionnaire-II (AAQ-II). Internalized Shame. Timepoint: Assessments were conducted before the intervention, immediately after the intervention, and three months following the completion of the intervention. Method of measurement: Internalized Shame Scale (ISS). Shahid Beheshti University of Medical Sciences Approved 2025-11-05 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Boulevard, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)