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IRCT20240311061251N1 IRCT 2024-07-16 Gorgan University of Medical Sciences Effect of Group Internet-Delivered Mindfulness Based Cognitive Therapy (MBCT) in Breast Cancer Patients comparison of effectiveness of group internet-delivered Mindfulness Based Cognitive Therapy in anxiety , depression and level of mindfulness in breast cancer patients receiving chemotherapy with the control group: a randomized controlled clinical trial 2024-06-21 anticipated 60 Complete https://irct.ir/trial/76926 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization technique is simple randomization. unit of randomization is individual participants. randomization tool is table of random numbers. Before starting of the study, Random numbers are generated using www.random.org by a member of the team who does not participate in the study. allocation concealment is done by sealed opaque envelopes. generated random numbers will be kept in sealed opaque envelopes until the start of the study. Allocation concealment will be maintained until the participant completes the demographic checklist. At this stage, the interviewer opened the sealed envelope to reveal the study group. N/A Condition 1: اختلال خلقی ناشی از وضعیت فیزیولوژیک شناخته شده با خصوصیات افسردگی. Condition 2: اختلال اضطرابی ناشی از وضعیت فیزیولوژیک شناخته شده. Intervention 1: Intervention group : Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented in both intervention and control groups. The intervention group are subjected to eight sessions of ninety minute weekly group internet-delivered Mindfulness Based Cognitive Therapy (iMBCT) in two groups of 15 participants. The iMBCT program is taken from the original version of Mindfulness-Based Cognitive Therapy from Segal et al.,2013 Handbook. then the post-tests will be administered in both groups. Intervention 2: Control group: Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented. During period of time that intervention group is recieving therapy, the control group is under usual care and does not receive any intervention. then the post-tests will be administered in both intervention and control groups. 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 more information
public Nazli Shaarbaf
No. 19,3rd Amini Alley, Janbaz14 Ave., Janbazan Blvd., Gorgan
Gorgan Iran (Islamic Republic of) 4916657661 00981749206 shaarbaf@goums.ac.ir Gorgan University of Medical Sciences scientific Nazli Shaarbaf
No.19 , 3rd amini alley , Janbaz14 Ave. , Janbazan Blvd.,Gorgan Town
Gorgan Iran (Islamic Republic of) 4916657661 +98 17 3234 9206 shaarbaf@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Breast cancer diagnosed by oncologist and based on pathology report The person must have basic internet and computer skills Access to the Internet at a suitable speed Age 20 to 55 years 20 years 55 years Female The presence of another concurrent cancer Having full criteria for other psychological disorders based on the researcher's clinical interview in accordance with DSM5 criteria Being under drug or non-drug treatment for psychiatric diseases Substance or alcohol abuse Having Active Suicidal or Homicidal ideas Low Performance Level related to cancer (equation ECOG 3 and 4) , which is determined by the Oncologist based on the ECOG Scale (the Eastern Cooperative Oncology Group Scale) F06.31 F06.4 Mood disorder due to known physiological condition with depressive features Anxiety disorder due to known physiological condition Treatment - Other Treatment - Other Intervention group : Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented in both intervention and control groups. The intervention group are subjected to eight sessions of ninety minute weekly group internet-delivered Mindfulness Based Cognitive Therapy (iMBCT) in two groups of 15 participants. The iMBCT program is taken from the original version of Mindfulness-Based Cognitive Therapy from Segal et al.,2013 Handbook. then the post-tests will be administered in both groups. Control group: Pre-test with Beck Depression Inventory - Second Edition (BDI-II), Beck Anxiety Inventory (BAI) and Five Facet Mindfulness Questionnaire (FFMQ) will be implemented. During period of time that intervention group is recieving therapy, the control group is under usual care and does not receive any intervention. then the post-tests will be administered in both intervention and control groups. Anxiety score in Beck Anxiety Inventory. Timepoint: The beginning of the study (before the intervention) and the end of the study (after the intervention). Method of measurement: Beck Anxiety Inventory. Depression score in Beck depression Inventory - second edition. Timepoint: The beginning of the study (before the intervention) and the end of the study (after the intervention). Method of measurement: Beck depression Inventory - second edition. Mindfulness level in Five Facet Mindfulness Questionnaire. Timepoint: The beginning of the study (before the intervention) and the end of the study (after the intervention). Method of measurement: Five Facet Mindfulness Questionnaire. Gorgan University of Medical Sciences Approved 2024-03-06 Ethics committee of Golestan University of Medical Sciences No.14, 3rd Amini Alley, 14 janbaz Ave.,Janbazan Blvd.,Gorgan Town Gorgan Golestan Iran (Islamic Republic of)