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IRCT20190924044866N5 IRCT 2025-09-30 Tabriz University of Medical Sciences The effectiveness of mindfulness-based cognitive therapy on resilience, quality of life, and tolerance of ambiguity in women with breast cancer MBCT The effectiveness of mindfulness-based cognitive therapy on resilience, quality of life, and tolerance of ambiguity in women with breast cancer 2025-09-23 anticipated 34 Complete https://irct.ir/trial/85894 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, to ensure both random and equitable allocation of participants, a rigorous scientific method known as concealed random allocation will be employed. The procedure will be conducted as follows: after determining eligible individuals and finalizing their enrollment, an independent colleague not involved in any other aspects of the trial will pre-determine the allocation sequence using a standard table of random numbers. To safeguard against manipulation or prediction, this predetermined random sequence will be immediately secured within sequentially numbered, opaque, sealed envelopes. Crucially, only after a participant is definitively enrolled in the study and all their baseline data has been completely collected will the corresponding envelope be opened to reveal their final group assignment—either to the intervention or control group, Blinding description: This study will implement a single-blind design where participants and outcome assessors will be blinded to group allocation, while therapists will remain unblinded due to the psychological nature of the intervention. N/A Breast Cancer. Intervention 1: Intervention group:Women with breast cancer: 8 mindfulness sessions. Intervention 2: Control group: Will continue standard medical care only, with identical assessments but no additional psychological intervention during the study period. 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 In order to protect the privacy of participants and to comply with research ethics, non-identifiable personal data in this study will not be made public. This decision is based on the confidentiality rules of the research center and the emphasis on the rights of participants to protect their personal information. However, the aggregated data and overall results of the study will be available to the scientific community.
public Ali Asgharzadeh
Razi Educational and Medical Center , El Goli Road
Tabriz Iran (Islamic Republic of) 5167846184 +98 41 5135 2308 ali.asgharzadeh72@gmail.com Tabriz University of Medical Sciences scientific Ali Asgharzadeh
El Goli Road , Razi Educational and Medical Center
Tabriz Iran (Islamic Republic of) 5167846184 +98 41 5135 2308 ali.asgharzadeh72@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Having at least an eighth grade education. Over 18 years old Breast cancer (all stages of the disease) Willingness to participate in research (informed consent) 18 years no limit Female • Withdrawal from further cooperation • Absence of more than two meetings Having another medical condition or having severe psychiatric disorders (such as psychotic disorders, bipolar and major depressive disorders, neurocognitive disorders and substance abuse) diagnosed by a psychiatrist within the last year. • History of receiving psychological interventions and taking psychiatric medications within the past 6 months C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Intervention group:Women with breast cancer: 8 mindfulness sessions Control group: Will continue standard medical care only, with identical assessments but no additional psychological intervention during the study period Resilience. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Connor and Davidson Resilience Questionnaire. Quality of life. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: WHO-QOL-BREF Questionnaire. Tolerance of ambiguity. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Ambiguity Tolerance Questionnaire. Tabriz University of Medical Sciences Approved 2025-07-01 Ethics Committee of Tabriz University of Medical Sciences Tabriz Medical School Address: Tabriz , Golgasht Street , Next to Imam Reza Hospital , Medical School Tabriz East Azarbaijan Iran (Islamic Republic of)