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IRCT20230529058323N1 IRCT 2023-08-30 Mashhad University of Medical Sciences Comparison of effectiveness of group behavioral activation intervention and Mindfulness-Based Cancer Recovery intervention Comparison of effectiveness of group behavioral activation intervention and Mindfulness-Based Cancer Recovery intervention based on online method on sleep quality, pain perception, anxiety and depression of breast cancer patients 2023-08-23 anticipated 102 Complete https://irct.ir/trial/70570 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization: Block randomization is performed by first creating blocks of desired size from the target data. These blocks are then randomly shuffled and finally arranged in order, resulting in a randomly block-permuted sequence. Tool Used: The website https://www.sealedenvelope.com was used with the explanation that each block consists of 6 members and the shape of the blocks can be, for example: [ABCABC], [BBAACC], [BCACBA], etc. The codes A, B, and C are randomly assigned to intervention and control groups. The website selects 18 random blocks out of all possible six-member blocks to ensure that all patients are included in the study. N/A breast cancer. Intervention 1: The first intervention group: MBCR intervention group: Mindfulness-based cancer recovery (MBCR) is an 8-week training program and a group based on tested and internationally recognized scientific evidence for cancer patients. The program was developed by Dr. Linda Carlson and Dr. Michael Speck at the University of Calgary and has been running as a clinical program for over 20 years. Intervention 2: The second intervention group: group behavioral activation: the members of the online behavioral activation intervention group will also receive behavioral activation training for 8 sessions of 50 minutes According to from Leahy, Holland & McGinn protocol of Behavioral activation therapy. Intervention 3: Members of the control group: No online intervention based on mindfulness and online intervention of behavioral activation will be implemented on the control members and they will only receive routine care. The meaning of routine care is the medical treatment required based on the opinion of the attending physician. Yes - There is a plan to make this available What will be shared: The SPSS file contains the information of the questionnaires. The scores of people in the questionnaires can be shared after removing the names of the participants. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Send an email to the responsible author to receive the SPSS results file Where to obtain: Responsible Author: Dr Farshad Sheybani Email: sheibanifr@mums.ac.ir How to obtain: The applicant can email the responsible author and receive the result file within 10 days. Comments:
public Farshad Sheybani
Hore-ameli St, Mashhad
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2701 sheibanifr@mums.ac.ir Mashhad University of Medical Sciences scientific Farshad Sheybani
Hore-Ameli St, Mashhad
Mashhad Iran (Islamic Republic of) 919598313 +98 51 3711 2701 sheibanifr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Their age group is between 20 and 65 years. Definitive diagnosis of breast cancer by an oncologist. Have minimum education to answer the questionnaires. person in the early stages of receiving treatment (early breast cancer without metastasis) smartphone access to the internet 20 years 65 years Female Absence of more than two sessions. Unwillingness of the person to complete the interventions Having previous experience of yoga or meditation exercises in the past few months Under treatment by a psychologist or other psychiatrist Failure to respond to questionnaires Failure to carry out relevant instructions and exercises in meetings C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Treatment - Other The first intervention group: MBCR intervention group: Mindfulness-based cancer recovery (MBCR) is an 8-week training program and a group based on tested and internationally recognized scientific evidence for cancer patients. The program was developed by Dr. Linda Carlson and Dr. Michael Speck at the University of Calgary and has been running as a clinical program for over 20 years. The second intervention group: group behavioral activation: the members of the online behavioral activation intervention group will also receive behavioral activation training for 8 sessions of 50 minutes According to from Leahy, Holland & McGinn protocol of Behavioral activation therapy. Members of the control group: No online intervention based on mindfulness and online intervention of behavioral activation will be implemented on the control members and they will only receive routine care. The meaning of routine care is the medical treatment required based on the opinion of the attending physician. Depression. Timepoint: 1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week). Method of measurement: Beck's depression questionnaire. Pain. Timepoint: 1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week). Method of measurement: Pain Intensity Scale Questionnaire (BPI). Anxiety. Timepoint: 1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week). Method of measurement: Beck's anxiety questionnaire. Sleep quality. Timepoint: 1-before the intervention (week zero) 2-after the intervention (60 days after the evaluation) (initial, 8th week) 3- 30 days after the end of the intervention (12th week). Method of measurement: Pittsburgh Sleep Quality Index. Mashhad University of Medical Sciences Approved 2023-01-31 Ethics committee of Mashhad University of Medical Sciences Omid Hospital, alaNadasht Crossroads, Koh Sengi St. Mashhad Razavi Khorasan Iran (Islamic Republic of)