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IRCT20260513069394N1 IRCT 2026-05-17 Islamic Azad University Investigating the effect of mindfulness training on improving mental health in people with anxiety and depression The Efficacy of Mindfulness-Based Cognitive Therapy (MBCT) on Rumination and Emotion Regulation in Patients with Anxiety and Depression 2026-06-05 anticipated 40 Complete https://irct.ir/trial/90129 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population of the study will comprise all employed women attending counseling center during the period of June 2026. In this type of effectiveness study, a two-stage approach is typically used: in the sampling stage, convenience sampling is employed. After selecting a sample of 40 participants, based on the study’s inclusion and exclusion criteria, participants will be randomly assigned to two groups: “Mindfulness-Based Cognitive Behavioral Therapy” (intervention group) and “Waiting List” (control group). Randomization will be performed using permuted random blocks with variable sizes (4 and 6 participants) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and sequentially numbered envelopes to ensure the researcher and participants remain unaware of the allocation sequence (allocation concealment). The envelope will be opened, and the assigned group will be revealed only at the time each participant enters the study. To ensure baseline equivalence of variables (such as anxiety level and age), their distribution between the two groups will be examined during the statistical analysis phase. N/A Anxiety and Depression. Intervention 1: Intervention group: Mindfulness-Based Cognitive Behavioral Therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions, Session sequence: Twice a week; Key therapeutic tools: This intervention focuses on mindfulness, acceptance, emotional regulation, and coping with rumination. Main therapeutic tools include: Mindfulness exercises, training attention to the present moment, non-judgmental observation of thoughts and emotions. Session content: Session 1: Introduction to the therapy, explaining objectives, and pre-test administration. Session 2: Teaching the basics of mindfulness and attention to present moment experience. Session 3: Identifying automatic thoughts and dysfunctional thought patterns. Session 4: Practicing non-judgmental observation and acceptance of thoughts and emotions. Session 5: Teaching body awareness and practicing breathing and relaxation. Session 6: Working on emotional regulation and coping with rumination. Session 7: Practical mindfulness exercises in everyday situations. Session 8: Session summary, reviewing exercises, post-test administration, and determining follow-up. Intervention 2: Control group: The control group will not receive any intervention during the research, but will receive the treatment intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization. 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 Due to the lack of completion of the research work and the failure to write the article, which is a requirement for publishing the data, I will publish the data as soon as the aforementioned issues are resolved.
public Fatemeh Hallajzadeh
No. 23, Karkheh Street, Corner of Karkheh 3, East 13th Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155976185 +98 61 3333 3333 fatemehhallajzadeh7@gmail.com Islamic Azad University scientific Fatemeh Hallajzadeh
No. 23, Karkheh Street, Corner of Karkheh 3, East 13th Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155976185 +98 61 3333 3333 fatemehhallajzadeh7@gmail.com Islamic Azad University Iran (Islamic Republic of) Women in their 30s and 40s Diagnosis of anxiety, depression, or anxiety-depression comorbidity based on a clinical interview or validated questionnaire Score above the cutoff on standard depression or anxiety questionnaires Experience of frequent rumination as measured by questionnaire score or self-report 30 years 40 years Female Unwillingness to participate in research Concurrent participation in other active psychological therapies F41.3 Other mixed anxiety disorders Treatment - Other Treatment - Other Intervention group: Mindfulness-Based Cognitive Behavioral Therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions, Session sequence: Twice a week; Key therapeutic tools: This intervention focuses on mindfulness, acceptance, emotional regulation, and coping with rumination. Main therapeutic tools include: Mindfulness exercises, training attention to the present moment, non-judgmental observation of thoughts and emotions. Session content: Session 1: Introduction to the therapy, explaining objectives, and pre-test administration. Session 2: Teaching the basics of mindfulness and attention to present moment experience. Session 3: Identifying automatic thoughts and dysfunctional thought patterns. Session 4: Practicing non-judgmental observation and acceptance of thoughts and emotions. Session 5: Teaching body awareness and practicing breathing and relaxation. Session 6: Working on emotional regulation and coping with rumination. Session 7: Practical mindfulness exercises in everyday situations. Session 8: Session summary, reviewing exercises, post-test administration, and determining follow-up. Control group: The control group will not receive any intervention during the research, but will receive the treatment intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization. Rumination. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The variable will be measured using the Nolen-Hoeksma and Maru (1991) rumination questionnaire. Emotion Regulation. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The variable will be measured using the Gross and John (2003) emotion regulation questionnaire. Anxiety. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The variable will be measured using the Beck et al. (1988) anxiety scale. Depression. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The variable will be measured using the Beck et al. (1996) Depression Questionnaire. Islamic Azad University Approved 2026-04-30 Ethics Committee of Islamic Azad University of Ahvaz Branch Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)