Protocol summary

Study aim
Comparison of the effect of positive behavioral therapy and cognitive behavioral therapy on cognitive flexibility, women with breast cancer
Design
Among the people who have received a diagnosis, according to the entry and exit criteria, we prepare a list and randomly select 45 of them, and randomly divide them into three groups. Then, randomly, one of the groups will be used as a control group, the other group as experimental group 1 (positive behavioral therapy), and the third group as experimental group 2 (cognitive behavioral therapy).
Settings and conduct
45 women with breast cancer referred to Milad Shahr Hospital in Tehran were selected and answered the cognitive flexibility questionnaire, then they were randomly assigned to three groups using the rand function of Excel software, and after identifying the three groups Each group was placed in one of the plans, and the control group did not receive information about the process and how it was implemented until the end of the research. Educational sessions in the field of cognitive flexibility at the positive life center under the cover of the welfare organization on a weekly basis for 8 sessions of 90 minutes (Fridays: cognitive behavioral therapy group from 9 to 10:30 and positive therapy group from 11 to 12 :30) was taught.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with breast cancer who have completed at least one month of their chemotherapy period must declare full consent to participate in the research. Exclusion criteria: history of psychiatric and psychological interventions during the past year, use of psychiatric drugs
Intervention groups
group cognitive behavioral therapy، positive behavioral therapy، control group
Main outcome variables
Cognitive flexibility, perception of controllability, perception of justification of behavior, perception of different options.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220212054000N1
Registration date: 2022-12-11, 1401/09/20
Registration timing: retrospective

Last update: 2022-12-11, 1401/09/20
Update count: 0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Mona DanaeiKousha
Name of organization / entity
Islamic Azad University of Birjand
Country
Iran (Islamic Republic of)
Phone
+98 21 6453 8495
Email address
mona.dk@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-22, 1400/02/02
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
2021-04-22, 1400/02/02
Actual recruitment end date
2021-05-05, 1400/02/15
Trial completion date
2021-10-22, 1400/07/30
Scientific title
Comparison of the effectiveness of group positive behavior therapy and group cognitive behavioral therapy on cognitive flexibility, women with breast cancer .
Public title
Investigating the effect of group positive behavioral therapy and group cognitive behavioral therapy on cognitive acceptability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having completed at least one month of chemotherapy having at least a diploma being married
Exclusion criteria:
History of psychiatric and psychological interventions during the past year taking psychiatric drugs being single having a physical illness such as diabetes
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After performing the pre-test stage in a joint session, people were randomly assigned a number using a list of numbers, and based on the lottery, the first person was placed in group 1, the second person was placed in group 2, and the third person was placed in group 3. Each group was randomly assigned to the first group (cognitive behavioral therapy), the second group (positive behavioral therapy), and the third group did not receive any intervention as a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals were blinded to be placed in groups, and after three groups were determined, each group was blindly placed in one of the plans (neither the participants nor the researcher knew about the placement of individuals in the groups until the day of the training sessions). The analyst did not know about the people and groups under analysis
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Damghan Ethics Expert Committee
Street address
Cheshme Ali Blvd
City
damghan
Province
Semnan
Postal code
3671637915
Approval date
2021-04-05, 1400/01/16
Ethics committee reference number
IR.IAU.DAMGHAN.REC.1400.004

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Cognitive flexibility
Timepoint
Beginning of the study (before the intervention) and end of the study (after the intervention) 60 days later
Method of measurement
Dennis and Vanderwall Cognitive Flexibility Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: cognitive behavioral therapy (education of cognitive and behavioral techniques during 8 sessions and each session for 90 minutes based on the Leahy protocol). Brief description of the group members' introduction and familiarization sessions with each other and the therapist, group members' familiarization with the rules and regulations of the group, answers to possible questions or doubts of the group members, explanation of the purpose and necessity of the sessions by the therapist, patient education in the field of the nature of the disease, familiarization of the patients with the models An existing opinion in the field of psychological aspects of pain-radiation therapy and its relationship with depressed mood and depression, behavioral activation training, familiarizing members with the conceptual model of classical cognitive-behavioral therapy, investigating the role of emotions in the experience of pain, the effect of negative thoughts and emotions on the aggravation of depression and Reducing activities, recognizing negative thoughts, introducing members to the techniques of managing negative emotions, learning and managing to deal with negative thoughts and emotions, problem solving skills, identifying thinking errors, the role of cognitions in the experience of negative feelings, training cognitive errors, training how to detect errors cognitive, training in cognitive reconstruction techniques, coping with stress, training in relaxation and pleasant mental imagery, lifestyle, examining the achievements of t
Category
Behavior

2

Description
Group: Positive attitude therapy (behavioral techniques during 8 sessions and each session for 90 minutes based on Seligman's protocol) The summary of intervention training sessions on positive attitude therapy and the therapist's role and client's responsibilities were studied. The meaning is in the continuation of depression and emptiness of life. It is discussed in terms of three paths of happiness (pleasure, experience and meaning). The theory is about establishing and developing positive emotions. A special plan is designed to implement the abilities. Good memories against bad memories: In the context of the role of good and bad memories in maintaining health. It is discussed in terms of appreciation. The importance of positive emotions is discussed. We discuss the current activities to increase positive emotions.طبقه بندیbehavior
Category
Behavior

3

Description
Control group: no intervention (during the course, they only participated in the pre-test and post-test stages and did not receive any intervention.)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Mona DanaeiKousha
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614531
Phone
+98 21 6453 8495
Email
mona.dk@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Ali Abadi
Street address
Ayatollah Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811111
Phone
+98 915 160 2307
Email
info@iaubir.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University of Birjand
Full name of responsible person
Mona DanaeiKousha
Position
Lecturer at the non-profit Ivanki University and PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mehrshahr, Eram Blvd., Bustan St., Arshia Complex
City
Karaj
Province
Alborz
Postal code
3187661187
Phone
+98 21 6453 8495
Email
mona.dk@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
SamanehSadat Tabatabaei
Position
Assistant Professor of Islamic Azad University, Birjand branch
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Modarres 20
City
Birjand
Province
South Khorasan
Postal code
9713633863
Phone
+98 56 3235 7033
Email
Tabatabaee88@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Danaei Kousha
Position
Ph.D. student of Psychology, Birjand Azad University
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bostan Street, Mehrshahr, Aram Blvd
City
کرج
Province
Alborz
Postal code
3187661187
Phone
+98 21 6453 8495
Email
mona.dk@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be presented in excel without mentioning the participants. Protocols and results can be presented in reports.
When the data will become available and for how long
Three months after publishing the articles and defending the doctoral thesis
To whom data/document is available
Researchers working in the university
Under which criteria data/document could be used
Expansion of research results
From where data/document is obtainable
The first author's email is Mena Danai Kosha
What processes are involved for a request to access data/document
After the approval of other authors and stating the reason for using the data and mentioning the names of the authors in the desired plan, it is possible to send the data.
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