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IRCT20230929059548N1 IRCT 2023-10-24 Shiraz University of Medical Sciences Investigation the effect of mentalization - based treatment on the impulsive behaviors in cancer patients Investigating the effect of mentalization-based treatment on impulsive behaviors in cancer patients undergoing treatment 2023-10-23 anticipated 54 Complete https://irct.ir/trial/73080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples will be allocated to two control and intervention groups by randomization method of permutation blocks. Finally, the sample size was considered to be 54, and for proportionality and equality of allocation, the samples will be placed in 9 blocks of 6. The random allocation list will be prepared by Random Allocation software. Randomization will be done individually. Concealment will also be one-way blind. In this way, the people who analyze the results and the people who take the pre-test and post-test from the participants are unaware of the intervention, Blinding description: Blinding is performed in such a way that the people who analyze the results (outcome evaluator) and the people who take the pre-test and post-test from the participants are unaware of the intervention. N/A Cancer patients. Intervention 1: Intervention group: Mentalization-based therapy (MBT) is a special type of psychodynamic psychotherapy invented by Bateman and Fonagy. MBT is based on two main concepts: Balbi's attachment theory and mentalization. The main focus of MBT is to help the client bring their subjective experiences to the level of consciousness and facilitate a coherent and full sense of psychological agency. The goal of treatment is to grow and strengthen the mentalizing capacity through therapeutic relationships and increase the capacity of the patient to recognize the thoughts and feelings he experiences. Batman and Fonagy treatment protocol includes two parts: preliminary MBT and individual and group MBT. Preliminary MBT consists of 12 group therapy sessions, which are held weekly and each session lasts 1.5 hours, and after these sessions, individual and group sessions are offered to people, which are held in a period of 18 months. But according to Batman and Fonagy's conclusion; Evidence that this arrangement is optimal is lacking, suggesting that MBT should now be offered for shorter durations as well as as group or individual therapy. Therefore, in this study, only 12 preliminary MBT sessions will be conducted in person for the intervention group. After completing the interventions, the questionnaires will be given to both groups again. In each session, according to the protocol, they are taught about topics that include; The first session (what is mentalization and a mentalizing stance?), the second session (what does it mean to have a problem with mentalizing?), the third session (why do we have emotions and what are the basic types?), the fourth session (mentalizing emotions), the fifth session (the significance of attachment relationships), the sixth session (attachment and mentalizing), the seventh session (what is meant by impulsive behavior?), the eighth and ninth sessions(mentalization-based treatment), the tenth session (anxiety, attachment and mentalizing), the session It is the eleventh (depression, attachment and mentalizing) and the twelfth session (summary and conclusion). In each meeting, the objectives of the same meeting along with assignments are presented to the participants. Intervention 2: Control group: The control group will receive the educational content after the end of the intervention. 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 further information.
public Hanieh Edalati
Salman Farsi Blvd., Javanmardi Street, Eram Residential Complex, Block 2/6, Unit 131
Shiraz Iran (Islamic Republic of) 7145834538 +98 71 3730 7889 hanie.edd@gmail.com Shiraz University of Medical Sciences scientific Ladan Zarshenas
Namazi Square, Fatemeh(P.B.U.H) School of Nursing and Midwifery
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 zarshenas@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with gastrointestinal cancer Patients admitted to the outpatient department of Amir Shiraz Oncology Hospital Willingness to participate in the study Moderate to high impulsive behavior based on the Barrett Impulsivity Scale Failure to participate in similar treatment sessions no limit no limit Both Suffering from chronic mental and cognitive diseases Malignant Malignant neoplasms Other Other Intervention group: Mentalization-based therapy (MBT) is a special type of psychodynamic psychotherapy invented by Bateman and Fonagy. MBT is based on two main concepts: Balbi's attachment theory and mentalization. The main focus of MBT is to help the client bring their subjective experiences to the level of consciousness and facilitate a coherent and full sense of psychological agency. The goal of treatment is to grow and strengthen the mentalizing capacity through therapeutic relationships and increase the capacity of the patient to recognize the thoughts and feelings he experiences. Batman and Fonagy treatment protocol includes two parts: preliminary MBT and individual and group MBT. Preliminary MBT consists of 12 group therapy sessions, which are held weekly and each session lasts 1.5 hours, and after these sessions, individual and group sessions are offered to people, which are held in a period of 18 months. But according to Batman and Fonagy's conclusion; Evidence that this arrangement is optimal is lacking, suggesting that MBT should now be offered for shorter durations as well as as group or individual therapy. Therefore, in this study, only 12 preliminary MBT sessions will be conducted in person for the intervention group. After completing the interventions, the questionnaires will be given to both groups again. In each session, according to the protocol, they are taught about topics that include; The first session (what is mentalization and a mentalizing stance?), the second session (what does it mean to have a problem with mentalizing?), the third session (why do we have emotions and what are the basic types?), the fourth session (mentalizing emotions), the fifth session (the significance of attachment relationships), the sixth session (attachment and mentalizing), the seventh session (what is meant by impulsive behavior?), the eighth and ninth sessions(mentalization-based treatment), the tenth session (anxiety, attachment and mentalizing), the session It is the eleventh (depression, attachment and mentalizing) and the twelfth session (summary and conclusion). In each meeting, the objectives of the same meeting along with assignments are presented to the participants. Control group: The control group will receive the educational content after the end of the intervention. Score of impulsive behaviors in cancer patients based on Barrett's impulsivity scale. Timepoint: Measuring the level of impulsive behaviors at the beginning and end of the study. Method of measurement: Barrett impulsivity questionnaire. Shiraz University of Medical Sciences Approved 2023-08-26 Ethics Committee of Shiraz University of Medical Sciences Salman Farsi Blvd., Javanmardi Street, Eram Residential Complex, Block 2/6, Unit 131 Shiraz Fars Iran (Islamic Republic of)