Protocol summary

Study aim
Determining the effectiveness of emotion-focused therapy on aggression, distress tolerance, anxiety sensitivity, and rumination
Design
A controlled clinical trial with parallel groups, single-blind, randomized, on 40 female students. The rand function of Excel software was used for randomization.
Settings and conduct
This study is conducted on aggressive female eighth-grade students in Tehran. The experimental group receives emotion-focused therapy and the control group is placed on a waiting list. The assessors and data analysts are unaware of the grouping of participants (single-blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Physical health; Score one standard deviation above the mean in aggression; Female students aged 12 to 18 years; Exclusion criteria: Participation in other educational sessions at least one month before the study; Drug use; Having other mental health problems
Intervention groups
The intervention for the experimental group will be emotion-focused therapy, delivered in 12 90-minute group sessions. The content of the sessions will be based on the standard protocol of Greenberg et al. and will focus on identifying, processing, and regulating core emotions associated with aggression. The control group will be placed on a waiting list during this period and will not receive any active intervention. After the study is completed, a similar course of therapy will be offered to this group as an ethical consideration.
Main outcome variables
Aggression level; Distress tolerance; Anxiety sensitivity; Rumination.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250709066427N1
Registration date: 2025-08-25, 1404/06/03
Registration timing: prospective

Last update: 2025-08-25, 1404/06/03
Update count: 0
Registration date
2025-08-25, 1404/06/03
Registrant information
Name
Reyhane Roustaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 8420
Email address
reyhane.roustaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-20, 1404/06/29
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion-focused therapy on aggression, distress tolerance, anxiety sensitivity, and rumination in students.
Public title
Emotion-focused therapy on aggression, distress tolerance, anxiety sensitivity, and rumination
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Female students between 12 and 18 years old Physical health Score one standard deviation above the mean in aggression Willingness to participate in the study
Exclusion criteria:
Substance use Participate in other training sessions
Age
From 12 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block random assignment method will be used. First, the list of eligible students will be grouped into homogeneous blocks based on criteria such as aggression score and age. Then, from within each block, individuals will be randomly assigned to two experimental and control groups using random number generator software. This process will be performed by a research associate who is not involved in the implementation of the intervention and evaluation to maintain objectivity and randomness of the process.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study design, the method will be single-blind. The assessors who collect data on aggression, distress tolerance, and other variables, as well as the data analyst, will be unaware of the allocation of participants to the experimental and control groups. This is done to avoid bias in measurement and analysis. Only the interventionist will be aware of the grouping, as the nature of the treatment does not allow for blinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz Branch
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Approval date
2025-07-26, 1404/05/04
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.271

Health conditions studied

1

Description of health condition studied
Clinical symptoms of aggression
ICD-10 code
F91.8
ICD-10 code description
Other conduct disorders

Primary outcomes

1

Description
Aggression
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Aggression Questionnaire (AGQ)

Secondary outcomes

1

Description
Distress tolerance:
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Distress Tolerance Questionnaire

2

Description
Anxiety sensitivity
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Floyd et al.'s Anxiety Sensitivity Index (2005)

3

Description
Rumination
Timepoint
At the beginning of the study (before the intervention began) and two months later (when the intervention ended)
Method of measurement
Rumination Questionnaire

Intervention groups

1

Description
Intervention group: The intervention for the experimental group will be emotion-focused therapy, delivered in 12 90-minute group sessions. The content of the sessions will be based on the standard protocol of Greenberg et al. and will focus on identifying, processing, and regulating core emotions associated with aggression.
Category
N/A

2

Description
Control group: The control group will be on a waiting list during this period and will not receive any active intervention. After the study is completed, a similar course of treatment will be offered to this group as an ethical consideration.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Unit
Full name of responsible person
Sasan bavi
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.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
Full name of responsible person
Sasan bavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 916 607 5133
Email
info@iauahvaz.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sasan bavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 916 607 5133
Email
info@iauahvaz.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reyhane Roustaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Fax
Email
Reyhane.roustaei@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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