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IRCT20260701070039N1 IRCT 2026-08-22 Islamic Azad University Investigating the effect of mindfulness in reducing psychological symptoms in women with obsessive-compulsive disorder. The effectiveness of mindfulness-based cognitive therapy on reducing perceived stress, anxiety, and psychosomatic symptoms in female patients with obsessive-compulsive disorder. 2026-08-20 anticipated 60 Complete https://irct.ir/trial/91398 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were allocated to two intervention groups (mindfulness-based cognitive therapy) and control groups in a 1:1 ratio. The method used is simple randomization, in which the randomization unit is the participant; cluster or stratified allocation methods were not used in this study. The random sequence was prepared using the random number generator of IBM SPSS Statistics software version 26 by a third party outside the main research team (independent of the implementation and evaluation process). For this purpose, an independent random number from a uniform distribution in the range [0,1] was generated for each of [N] participants using the RANDOM function and by fixing the initial number for sequence reproducibility; participants whose generated number was less than 0.5 were placed in the intervention group and the rest in the control group. In order to ensure allocation concealment and prevent group prediction, opaque, opaque, sealed, and numbered envelopes in sequential order (from 1 to [N]) were used. The name of the group (intervention or control) is written on cards and placed inside the envelopes according to the random sequence prepared. The identification code of each participant is written on the relevant envelope only after his/her entry into the study is confirmed and informed consent is obtained. The envelope is opened only by the main study administrator, in the presence of the participant and after the registration and baseline assessments are completed. In this way, the researcher and the participant remain unaware of the relevant group until the final moment of allocation. N/A Condition 1: Obsessive-compulsive disorder. Condition 2: Generalized anxiety disorder. Condition 3: Somatization disorder. Intervention 1: Intervention group: 1- Pre-test: Before the start of the first session, all participants in the intervention group will be given tests related to the research variables. 2- Implementation of the intervention: The sessions will be presented regularly and step by step according to the mentioned educational content. The intervention includes an educational-training course consisting of 8 sessions that will be held weekly. The total duration of the intervention is 2 months (8 weeks). The steps of implementing the intervention are as follows:. Practical homework-based exercises for use at home will be provided to the participants at the end of each session. 3- Post-test: Immediately after the end of the eighth session, a post-test will be taken from the group members to evaluate the changes achieved. Follow-up test: In order to measure the sustainability of the intervention effects, a follow-up stage will be conducted 60 days after the end of the last session by re-administering the tests. Session content: Session 1: Introduction and basics of mindfulness: explaining the goals of treatment, getting to know each other, defining the concept of mindfulness, and practicing "conscious eating" to understand presence in the moment. Session 2: Understanding the mind and thoughts: examining how the mind works, distinguishing between "being" and "doing," and practicing "observing thoughts as mental events" (not objective facts). Session 3: Focusing on the body: teaching the "body scan" exercise to identify physical tensions caused by obsessions and improving sensory awareness. Session 4: Facing difficulties: teaching an acceptance approach to obsessive thoughts and unpleasant feelings; replacing avoidance with active observation. Session 5: Acceptance and release: practicing the "three-minute breathing space" technique to manage impulses and obsessive thoughts in critical moments. Session 6: Unpleasant thoughts and emotions: examining the relationship between negative automatic thoughts and symptoms of obsessions; Practice "cognitive distancing" from thought content.Session 7: Self-care and adaptive skills: Identifying warning signs of relapse and developing an action plan for self-care in stressful situations.Session 8: Summary and relapse prevention: Reviewing key learnings, examining challenges in the treatment path, emphasizing continuity of practice in daily life, and discussing strategies for maintaining treatment gains.In these sessions, mindfulness skills and practical exercises are taught. In the final sessions, emphasis is placed on consolidating learning, practicing adaptive strategies, and preventing relapse.After completing the intervention sessions, participants will be given a post-test. Also, in order to assess the sustainability of the treatment effects, a follow-up test will be conducted for the intervention group 60 days after the end of the intervention. Intervention 2: Control group: No intervention will be performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nahid Pourameri
No. 162, Between Zahed and Manateq Sts., Komeil St., Zeytoon-e Karmandi, Ahvaz, Khuzestan, Iran.
Ahvaz Iran (Islamic Republic of) 6164635686 +98 61 3334 6898 nahid.pourameri@gmail.com Islamic Azad University scientific Samira Seyed Asiaban
Third Floor, Faculty of Humanities, Islamic Azad University, Ahvaz Branch, Farhang-shahr, Golestan Highway, Ahvaz, Iran.
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8420 Seyedasiaban63@yahoo.com Islamic Azad University Iran (Islamic Republic of) Willingness to participate in research Age range 20 to 45 years Acceptance of the rules of participation in the course Having obsessive-compulsive disorder as diagnosed by a psychiatrist Having at least a high school diploma or equivalent to answer the questionnaire questions 20 years 45 years Female Currently receiving pharmacotherapy for any Axis I or Axis II psychiatric disorder. The presence of learning disabilities or cognitive deficits that impair understanding of mindfulness concepts Participating in other treatment programs while participating in research F42 F41.1 F45.0 Obsessive-compulsive disorder Generalized anxiety disorder Somatization disorder Treatment - Other Other Intervention group: 1- Pre-test: Before the start of the first session, all participants in the intervention group will be given tests related to the research variables. 2- Implementation of the intervention: The sessions will be presented regularly and step by step according to the mentioned educational content. The intervention includes an educational-training course consisting of 8 sessions that will be held weekly. The total duration of the intervention is 2 months (8 weeks). The steps of implementing the intervention are as follows:. Practical homework-based exercises for use at home will be provided to the participants at the end of each session. 3- Post-test: Immediately after the end of the eighth session, a post-test will be taken from the group members to evaluate the changes achieved. Follow-up test: In order to measure the sustainability of the intervention effects, a follow-up stage will be conducted 60 days after the end of the last session by re-administering the tests. Session content: Session 1: Introduction and basics of mindfulness: explaining the goals of treatment, getting to know each other, defining the concept of mindfulness, and practicing "conscious eating" to understand presence in the moment. Session 2: Understanding the mind and thoughts: examining how the mind works, distinguishing between "being" and "doing," and practicing "observing thoughts as mental events" (not objective facts). Session 3: Focusing on the body: teaching the "body scan" exercise to identify physical tensions caused by obsessions and improving sensory awareness. Session 4: Facing difficulties: teaching an acceptance approach to obsessive thoughts and unpleasant feelings; replacing avoidance with active observation. Session 5: Acceptance and release: practicing the "three-minute breathing space" technique to manage impulses and obsessive thoughts in critical moments. Session 6: Unpleasant thoughts and emotions: examining the relationship between negative automatic thoughts and symptoms of obsessions; Practice "cognitive distancing" from thought content.Session 7: Self-care and adaptive skills: Identifying warning signs of relapse and developing an action plan for self-care in stressful situations.Session 8: Summary and relapse prevention: Reviewing key learnings, examining challenges in the treatment path, emphasizing continuity of practice in daily life, and discussing strategies for maintaining treatment gains.In these sessions, mindfulness skills and practical exercises are taught. In the final sessions, emphasis is placed on consolidating learning, practicing adaptive strategies, and preventing relapse.After completing the intervention sessions, participants will be given a post-test. Also, in order to assess the sustainability of the treatment effects, a follow-up test will be conducted for the intervention group 60 days after the end of the intervention. Control group: No intervention will be performed The score that the subject obtains from the Cohen Perceived Stress Questionnaire. Timepoint: Before the intervention begins (pre-test), after the intervention ends (post-test). Method of measurement: Cohen's Perceived Stress Scale (PSS). The score that the subject obtains from the Spielberger Anxiety Inventory (STAI-Y). Timepoint: Before the intervention begins (pre-test), after the intervention ends (post-test). Method of measurement: Spielberger Anxiety Inventory (STAI-Y). The score that the subject obtains from the Lacourt Psychosomatic Symptoms Questionnaire. Timepoint: Before the intervention begins (pre-test), after the intervention ends (post-test). Method of measurement: Lacourt Psychosomatic Symptoms Questionnaire (2013). Islamic Azad University Approved 2026-05-26 Research Ethics Committee ،Islamic Ahvaz University 3rd Floor, Administrative Building, Islamic Azad University, Ahvaz Branch, Farhang Shahr, Golestan Highway, Ahvaz, Iran. Ahvaz Khouzestan Iran (Islamic Republic of)