Determining the effect of treatment based on mentalization on impulsive behaviors in cancer patients treated at Amir Oncology Hospital, Shiraz University of Medical Sciences in 1401
Design
The clinical trial has a control group, a blind strain, randomized, the sample size is 54 people, and the intervention will be done on 27 people. Random software is used for randomization.
Settings and conduct
Outpatient Chemotherapy Department of Amir Hospital, random sampling and allocation of 27 people to the intervention group, holding 12 treatment sessions based on Fonagy mentalization in one and a half hour sessions, single-blinding for the outcome evaluator and people who pre-test and post-test The test is taken from the participants
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with gastrointestinal cancer in the outpatient department of Amir Hospital; moderate to high impulsivity score; Willingness to participate in the study. Exclusion criteria: history of participating in similar meetings; Suffering from chronic mental and cognitive diseases
Intervention groups
Holding 12 sessions of one and a half hour treatment based on mentalization according to the Fonagy protocol for the intervention group on a weekly basis, re-giving the questionnaires to both groups after the end of the intervention, receiving educational content after the end of the intervention by the control group
Main outcome variables
Knowing the levels of impulsive behaviors of cancer patients and its relationship with mentalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230929059548N1
Registration date:2023-10-24, 1402/08/02
Registration timing:registered_while_recruiting
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Hanieh Edalati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3730 7889
Email address
hanie.edd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mentalization-based treatment on impulsive behaviors in cancer patients undergoing treatment
Public title
Investigation the effect of mentalization - based treatment on the impulsive behaviors in cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Suffering from chronic mental and cognitive diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Salman Farsi Blvd., Javanmardi Street, Eram Residential Complex, Block 2/6, Unit 131
City
Shiraz
Province
Fars
Postal code
7145834538
Approval date
2023-08-26, 1402/06/04
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.058
Health conditions studied
1
Description of health condition studied
Cancer patients
ICD-10 code
Malignant
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
Control group: The control group will receive the educational content after the end of the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Ali Amanati
Street address
Farhang Shahr Street, 11th Station, Amir Oncology Hospital
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3532
Email
amirhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand St., Central Building, Shiraz University of Medical Sciences, 7th floor, Research and Technology Vice-Chancellor
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2314
Email
vcrdept4@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Edalati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Salman Farsi Blvd., Javanmardi Street, Eram Residential Complex, Block 2/6, Unit 131
City
Shiraz
Province
Fars
Postal code
7145834538
Phone
+98 71 3730 7889
Email
hanie.edd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, Fatemeh(P.B.U.H) School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zarshenas@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Edalati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 131, Block 6/2, Eram Residential Complex, Javanmardi St., Salman Farsi Blvd.
City
Shiraz
Province
Fars
Postal code
7145834538
Phone
+98 71 3730 7889
Fax
Email
hanie.edd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available