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IRCT20260522069488N1 IRCT 2026-06-24 Azad University Of Marvdasht The effect of mindfulness-based cognitive behavioral therapy on memory in breast cancer survivors The effectiveness of mindfulness-integrated cognitive behavioral therapy (MiCBT) on episodic and semantic memory among breast cancer survivors 2026-06-22 anticipated 30 Complete https://irct.ir/trial/90341 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a two-arm randomized controlled trial with a parallel design. Participants will be randomly allocated to either the MiCBT intervention group or the control group. Outcome assessments will be conducted at baseline (pre-test) and after the intervention (post-test). The intervention will be delivered through structured psychotherapy sessions, while the control group will not receive the specific intervention. Outcomes will be measured using standardized self-report questionnaires, Randomization description: Participants will be randomly assigned to either the MiCBT intervention group or the control group using a simple randomization method (e.g., computer-generated random numbers or drawing lots). Each participant will be allocated to a group without any systematic order. To prevent prediction of group assignment, the allocation sequence will not be disclosed to the researcher in advance. N/A Breast Cancer Survivors. Intervention 1: Intervention group: Participants in this group will receive Mindfulness Integrated Cognitive Behavioral Therapy (MICBT). The intervention consists of eight structured group sessions. Each session includes mindfulness training, cognitive restructuring, attentional exercises, and related homework assignments. Sessions will be conducted weekly in an outpatient clinical setting. Intervention 2: Control group: Participants in this group will not receive any specific psychological intervention and will only complete the baseline and post intervention assessments. They may continue to receive their usual care if needed. Yes - There is a plan to make this available What will be shared: Individual participant data include demographic characteristics, scores of fear of cancer recurrence, body image, post-traumatic growth questionnaires, and psychological test scores at baseline and post intervention. Data will be shared after removal of all personal identifiers (de-identified dataset). When: Data will be available 6 months after publication of the study results and will remain accessible for 5 years. To whom: Access to data will be granted to researchers affiliated with academic or research institutions with legitimate scientific objectives. Requests from non-academic or commercial entities will not be considered. Conditions: Data will be used only for non-commercial research purposes. Any analysis must comply with ethical research standards, and secondary analyses must align with approved scientific objectives. Redistribution of data is not permitted. Where to obtain: Requests should be submitted via the principal investigator’s email. After scientific review and approval, de-identified data will be shared in digital format with the requester. How to obtain: Requests will be reviewed by the research team. If approved, data will be provided within 30 working days. A Data Use Agreement may be required prior to data sharing. Comments: All datasets will be fully de-identified and no personal identifiers will be shared.
public Dr. Mohsen Arefian
Jahrom University, jahrom, Fars province, Iran
jahrom Iran (Islamic Republic of) 7414785318 +98 71 5437 2252 M.arefian92@gmail.com Jahrom University scientific Dr. Mohsen Arefian
Jahrom University, jahrom, Fars province, Iran
jahrom Iran (Islamic Republic of) - +98 917 392 0656 M.arefian92@gmail.com Jahrom University Iran (Islamic Republic of) Female breast cancer survivors Age between 18 and 50 years At least 6 months since completion of primary cancer treatment (surgery, chemotherapy, or radiotherapy) Ability to read and write in Persian No current severe psychiatric disorders (e.g., psychosis or severe bipolar disorder) Not receiving concurrent structured psychological treatmen Willingness to participate and provide informed consent 18 years 50 years Female Diagnosis of severe psychiatric disorders (e.g., psychotic disorders or bipolar I disorder Severe cognitive impairment or neurological disorders affecting participation Current substance or alcohol dependence Unstable or acute medical conditions during study period Inability to attend intervention sessions regularly (e.g., more than 2 missed sessions) Withdrawal of consent at any stage of the study Behavior Other Intervention group: Participants in this group will receive Mindfulness Integrated Cognitive Behavioral Therapy (MICBT). The intervention consists of eight structured group sessions. Each session includes mindfulness training, cognitive restructuring, attentional exercises, and related homework assignments. Sessions will be conducted weekly in an outpatient clinical setting. Control group: Participants in this group will not receive any specific psychological intervention and will only complete the baseline and post intervention assessments. They may continue to receive their usual care if needed. Episodic Memory Score in Breast Cancer Survivors. Timepoint: Assessment at Baseline (Before the Intervention) and After Completion of the Intervention Sessions. Method of measurement: Episodic memory will be assessed using the California Verbal Learning Test Second Edition, the Logical Memory Subtest of the Wechsler Memory Scale Fourth Edition, and the Autobiographical Recollection Test. Semantic Memory Score in Breast Cancer Survivors. Timepoint: Assessment at Baseline (Before the Intervention) and After Completion of the Intervention Sessions. Method of measurement: Semantic memory will be assessed using the Semantic Verbal Fluency Test. Azad University Of Marvdasht Approved 2026-06-08 Research Ethics Committees of Islamic Azad University-Marvdasht Branch Islamic Azad University, Marvdasht Branch, Kilometer 3, Takht-e Jamshid Boulevard, Marvdasht, Fars Province, Iran Marvdasht Fars Iran (Islamic Republic of)