Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral therapy focused on problem solving on rumination,alexithymia and loneliness in students with aggressive behaviors
Design
A concealed, randomized, blinded, controlled clinical trial with a parallel group design of 30 students who were placed in the experimental or control group by assigning a code and lottery.
Settings and conduct
A school for girls and boys are selected as sampling units using the accessible method. As a sample, 30 students who scored higher than 75 in the Bass and Perry aggression questionnaire were randomly assigned to the experimental and control groups.The study is single-blind.Participants are unaware of the experiment.
Participants/Inclusion and exclusion criteria
The participants are the students of the first secondary school in the academic year of 1402-1403 in Neishabur city. Entry criteria - Failure to participate in other counseling and psychotherapy sessions at the same time - Satisfaction with participation in training sessions - Obtaining a score higher than 75 in Bass and Perry aggression questionnaire Exclusion criteria - Having an incurable physical disease such as cancer, seizure attacks, heart disease -Obtaining a low score in Bass and Perry's aggression questionnaire
Intervention groups
The intervention consists of eight one-hour sessions of problem solving skills training based on the Nezu and D,Zurilla protocol for the experimental group. The control group received no intervention. Before and after the end of the training sessions, both groups answer three questionnaires: rumination, alexithymia and loneliness.
Main outcome variables
Problem Solving Skill Training; Management of Aggressive Behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231125060172N1
Registration date: 2024-06-16, 1403/03/27
Registration timing: retrospective

Last update: 2024-06-16, 1403/03/27
Update count: 0
Registration date
2024-06-16, 1403/03/27
Registrant information
Name
Zeanab Soghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 0929
Email address
zsoghandi812@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral therapy focused on problem solving on rumination, alexithymia and loneliness in students with aggressive behaviors
Public title
The effectiveness of problem-solving cognitive behavioral therapy on aggression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Failure to participate in other counseling and psychotherapy sessions at the same time Consent to participate in Training sessions Obtaining a score higher than 75 in Bass and Perry aggression questionnaire Students studying in the first secondary section in 2024-2025
Exclusion criteria:
Having an incurable physical disease such as cancer, seizure attacks, heart disease Attending counseling or psychotherapy sessions in the previous six months Obtaining a low score in the aggression questionnaire
Age
From 13 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population is all the students of the first secondary schools of Neyshabur. Two schools are selected as sampling units using the accessible method. After implementing Bass and Perry's aggression questionnaire 30 students who scored higher than 75 are identified. Each student is assigned a number. Put the numbers in a container Put the numbers in a container and 15 students are selected by lottery for each of the control and experimental groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants of both groups do not know about the study and the experiment in which they are in, so they are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
In the current study, there are two experimental and control groups. The intervention consists of eight one-hour sessions, cognitive behavioral therapy focused on problem solving, derived from the treatment protocol of Nezu and Desorilla, which is performed on the experimental group. The control group does not receive any intervention. The scores of rumination, emotional dyslexia, and loneliness questionnaires of both groups are measured and compared before and after the intervention. The follow-up period is done after two months.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neyshabur Islamic Azad University
Street address
Neyshabur Islamic Azad University, Paghouhesh Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319975853
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1402.033

Health conditions studied

1

Description of health condition studied
Aggressive behaviors
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Aggressive behavior scores of students in Bass and Perry aggression questionnaire
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Bass and Perry Aggression Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group received eight one-hour sessions of problem solving skills based on the protocol of Nezu and DesorillSession 1: Familiarization and introduction of the members, review of goals and expectations, rules, explanation about the length and duration of the meetings, 2- Familiarization and training with the ABCD model. A events that happened. B is the opinion about that incident. C emotional consequences of this way of thinking, D discussion and challenge; recognize their negative spontaneous thoughts, get involved with these thoughts and try to gradually replace them with positive or logical thoughts. Specifying homework and thought recording sheets 3- Teaching problem solving steps including: explaining the treatment and its logic, diagnosis, definition and analysis of the problem, determining achievable goals, creating solutions, evaluating and choosing a solution, performing the selected solution, evaluation The result after the completion of the solution, determining the assignment, applying the problem solving method in life situations and recording it. 4- Introducing the use of joking in anger-inducing situations, explaining the concept of one's attitude to life with the use of humor along with maintaining the perspective-taking method. Setting the homework of using two sides of jokes (combating with enjoyable activities and using jokes to avoid anger) during the next week 5- Reviewing the concept of self-talk and emphasizing the difference between anger-increasing and anger-reducing self-talks, helping to identify more anger-increasing and anger-reducing self-talks, strengthening the ability to understand the concept of perspective-taking and the behavior of playing the intellectual game of self-talk in the meeting and also practicing it outside the meeting. 6- Teaching the successive stages of problem solving, including identifying the problem, thinking about the action, thinking about the consequences of the action (sequential thinking), generating a solution (substitution thinking), understanding step by step to achieve special goals (semantic thinking) and looking at the problem from the perspective of others (viewpointing) ) through the game of choice. 7- Training to differentiate between aggressive, passive, passive aggressive, and assertive responses. Determining the individual rights of people in different situations, identifying and confronting irrational thoughts that support non-assertive behaviors. Practicing assertive responses in various anger-stimulating situations through power play 8 -Reviewing and summarizing skills taught in past sessions to help participants apply them in future situations.
Category
Prevention

2

Description
Control group: 15 students who had an aggression score higher than 75 were randomly placed in this group. This group answered three questionnaires before the beginning and after the end of the training sessions of the experimental group: Nalen and Hoeksma rumination, TAS 20 Toronto and UCLA. The control group did not receive any training or treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
First secondary schools of the academic year 1402-1403 in the city of Neishabur
Full name of responsible person
Zeanab Soghandi
Street address
No. 19, 6/3 Amirkabir Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9314737459
Phone
+98 51 4334 0929
Email
zsoghandi812@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor of Research at Azad Neyshabur University
Full name of responsible person
Zeanab Soghandi
Street address
No. 19, 6/3 Amir Kabir Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9314734459
Phone
+98 51 4334 0929
Email
zsoghandi812@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research at Azad Neyshabur University
Proportion provided by this source
100
Public or private sector
Private
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
Full name of responsible person
Zeanab Soghandi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 19، 6/3 Amir kabir Ave.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9314737459
Phone
+98 51 4334 0929
Fax
Email
zsoghandi812@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeanab Soghandi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 19، 6/3 Amir kabir Ave.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9314737459
Phone
+98 51 4334 0929
Fax
Email
zsoghandi812@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeanab Soghandi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 19، 6/3 Amir kabir Ave.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9314737459
Phone
+98 51 4334 0929
Fax
Email
zsoghandi812@gmail.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
Yes - There is 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 is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Students with aggressive behaviors, schools, education, counseling centers and psychological clinics can benefit from the results of this research.
From where data/document is obtainable
zsoghandi802@gmail.com
What processes are involved for a request to access data/document
Three months after submitting the application
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