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IRCT20220113053705N2 IRCT 2025-07-06 Sanandaj University of Medical Sciences The effectiveness of Minfdul Interoceptive Exposure on improvement of OCD symptoms The effectiveness of Minfdul Interoceptive Exposure on improvement of symptoms of patients with Obsessive Compulsive Disorder 2025-07-02 anticipated 30 Complete https://irct.ir/trial/84536 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After identifying and selecting eligible participants, they will be randomly assigned to the study groups through a lottery method. Specifically, the participants’ names will be written on identical cards, which will then be randomly drawn from a designated container to divide the individuals into intervention and control groups. This approach is used to eliminate any potential bias in the allocation process and to enhance the internal validity of the study, Blinding description: During the data analysis phase, the clinical evaluator or researcher reviewing the data is kept unaware of the participants' group assignments and their characteristics. The data are coded or anonymized in a way that prevents the evaluator from identifying which data belongs to which group. This procedure helps prevent evaluator bias in interpreting and assessing the data, thereby enhancing the validity of the study results. 3 Obsessive-Compulsive Disorder. Intervention 1: Intervention group: The intervention group receives mindfulness-based exposure therapy as the treatment, which consists of four therapy sessions with specific goals and strategies. Details of the weekly sessions are provided in Table 1. This therapy is a third-wave cognitive-behavioral treatment and is one of the transdiagnostic approaches that utilize mindfulness skill training along with cognitive-behavioral techniques. All sessions (Sessions 1–8) are outlined according to the relevant protocol (Sohrabi et al., 2024; Kiyon, 2011; Kiyon, Francis & Shirz, 2018).The primary goal of the therapy, following the therapeutic contract and client preparation, is to facilitate the process of change, which continues with several main objectives pursued across multiple sessions. The first phase is introversion, which focuses on developing attention skills, attention restoration, and attention regulation within the context of emotion regulation, using mindfulness techniques.Next, in the extroversion phase, the learned skills provide a basis for confronting intrapersonal problems, employing mindful exposure techniques to address harmful personal contexts. Then, as skills expand, the interpersonal and extrapersonal phases broaden this confrontation to wider interpersonal contexts. Finally, these stages are integrated into a comprehensive therapeutic package. Intervention 2: Control group: After being assigned to the control group, participants do not receive any specific psychotherapeutic intervention concurrently and continue to receive only their usual medication treatment. Yes - There is a plan to make this available What will be shared: Data related to the study will be provided in response to legitimate requests from the relevant organizations. When: After publication of the data To whom: Academic researchers can access the data upon submitting a formal and justified request. Conditions: The individual must have a verified identity and submit the request through an official or academic organization. They must accept responsibility for maintaining confidentiality and not disclosing the data without permission, in accordance with ethical principles. Where to obtain: They can correspond via the following email to make a request: F.sohrabi20@gmail.com How to obtain: After receiving the email and reviewing it through official channels, the request will be responded to as soon as possible. Comments:
public Fateh Sohrabi
Clinical Psychology Branch, Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4664 f.sohrabi20@gmail.com Sanandaj University of Medical Sciences scientific Fateh Sohrabi
Clinical Psychology Branch, Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4664 F.sohrabi20@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) • Willingness to participate in the study • Ability to read and write at a middle school level • Diagnosis of obsessive-compulsive disorder (OCD) based on a psychiatric evaluation • Not currently undergoing any psychotherapy • No changes in medication during the psychotherapy period 18 years no limit Both • Presence of a psychotic disorder or lack of insight in OCD • Having intellectual or cognitive impairments such as intellectual disability, dementia, or delirium • Concurrent substance use disorders F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other Intervention group: The intervention group receives mindfulness-based exposure therapy as the treatment, which consists of four therapy sessions with specific goals and strategies. Details of the weekly sessions are provided in Table 1. This therapy is a third-wave cognitive-behavioral treatment and is one of the transdiagnostic approaches that utilize mindfulness skill training along with cognitive-behavioral techniques. All sessions (Sessions 1–8) are outlined according to the relevant protocol (Sohrabi et al., 2024; Kiyon, 2011; Kiyon, Francis & Shirz, 2018).The primary goal of the therapy, following the therapeutic contract and client preparation, is to facilitate the process of change, which continues with several main objectives pursued across multiple sessions. The first phase is introversion, which focuses on developing attention skills, attention restoration, and attention regulation within the context of emotion regulation, using mindfulness techniques.Next, in the extroversion phase, the learned skills provide a basis for confronting intrapersonal problems, employing mindful exposure techniques to address harmful personal contexts. Then, as skills expand, the interpersonal and extrapersonal phases broaden this confrontation to wider interpersonal contexts. Finally, these stages are integrated into a comprehensive therapeutic package. Control group: After being assigned to the control group, participants do not receive any specific psychotherapeutic intervention concurrently and continue to receive only their usual medication treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Timepoint: Before the intervention starts – after completing the treatment sessions – and three months after the last session. Method of measurement: Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Anxiety Sensitivity Index-3. Timepoint: Before the intervention starts – after completing the treatment sessions – and three months after the last session. Method of measurement: Anxiety Sensitivity Index-3. Multidimensional Assessment of Interoceptive Awareness-2. Timepoint: Before the intervention starts – after completing the treatment sessions – and three months after the last session. Method of measurement: Multidimensional Assessment of Interoceptive Awareness-2. Depression, Anxiety and Stress scale. Timepoint: Before the intervention starts – after completing the treatment sessions – and three months after the last session. Method of measurement: Depression, Anxiety and Stress scale. kurdistan University Of medical Sciences Approved 2025-06-10 research ethics committees of Kurdistan university of medical sciences Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Ave. Sanandaj Kurdistan Iran (Islamic Republic of)