Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral therapy on feelings of shame and guilt, impulsive behaviors, and difficulty in emotion regulation
Design
The clinical trial will be a controlled, parallel-group, single-blind, randomized, controlled trial on 40 adolescents. It will be conducted using R software for block randomization (block size 4).
Settings and conduct
This quasi-experimental study will be conducted on 40 adolescents with high-risk behaviors in Ahvaz city, who will be randomly assigned to two groups of 20 (experimental and control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent, interest and willingness of individuals to participate in the research and their parents, ability to read, write and complete the informed consent form, age range of 14 to 17 years, symptoms of high-risk behaviors by the participant and subsequently obtaining a score higher than the average of this scale, adolescents with high-risk behaviors in Ahvaz city. Major exclusion criteria: Simultaneous participation in other training and treatments, having chronic physical disorders and inability to follow up the subject.
Intervention groups
The intervention group will receive a structured cognitive-behavioral therapy (CBT) program consisting of 12 weekly 60-minute sessions. The intervention will focus on emotion regulation training, cognitive restructuring of shame- and guilt-related beliefs, and impulse control skills training, and will be delivered by trained therapists in a clinic or school setting. The control group will receive usual psychological services (Treatment as Usual), consisting of unstructured counseling and periodic monitoring without the CBT protocol.
Main outcome variables
Feelings of shame, guilt, impulsive behaviors, difficulty regulating emotions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250703066357N1
Registration date: 2025-08-27, 1404/06/05
Registration timing: prospective

Last update: 2025-08-27, 1404/06/05
Update count: 0
Registration date
2025-08-27, 1404/06/05
Registrant information
Name
nilofar raessi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3461 3512
Email address
nilofarraessi@gmail.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 cognitive behavioral therapy on feelings of shame and guilt, impulsive behaviors, and difficulty in emotion regulation in adolescents with high-risk behaviors.
Public title
The effectiveness of cognitive behavioral therapy on feelings of shame and guilt, impulsive behaviors, and difficulty in emotion regulation.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent, interest and willingness of individuals to participate in the research and their parents Ability to read, write, and complete an informed consent form Age range 14 to 17 years The participant exhibits signs of high-risk behaviors and subsequently scores higher than the average on this scale. Adolescents with high-risk behaviors in Ahvaz city
Exclusion criteria:
Simultaneous participation in other training and treatments Having chronic physical disorders and not being able to follow up with the subject during the pre-test-post-test stages
Age
From 14 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In the future study, stratified randomization will be used. The unit of randomization will be the individual, and participants will be divided into strata based on key variables (such as gender and severity of risky behavior). Within each stratum, participants will be assigned to experimental and control groups using block randomization with a block size of 4. The random sequence will be generated using specialized software (such as R or SPSS) and placed in sealed envelopes or an online concealment system to reduce bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor who measures the primary and secondary outcomes (shame, guilt questionnaires, etc.) will be kept unaware of each participant’s allocation to the intervention or control group. The allocation of participants to groups will be done by an independent collaborator who is not involved in the assessment or intervention process, and the list will be kept confidential. The raw data will be provided to the analyst for statistical analysis, with non-specific codes (e.g. Group 1 and Group 2). The true identity of the groups (experimental or control) will only be revealed to the analyst after the primary final analyses have been completed. Due to the active nature of the psychosocial intervention, participants and therapists will be aware of their group and therefore will not be blinded.
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
2025-08-16, 1404/05/25
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.344

Health conditions studied

1

Description of health condition studied
Risky behaviors in adolescents
ICD-10 code
Z72.9
ICD-10 code description
Problem related to lifestyle, unspecified

Primary outcomes

1

Description
feeling ashamed
Timepoint
Outcome variables will be measured at three time points: pre-intervention, end of intervention, and 3-month follow-up
Method of measurement
Shame and Guilt Questionnaire by Cohen et al. (2011)

Secondary outcomes

1

Description
Risky behaviors
Timepoint
Risky behaviors will be measured at three time points: before the intervention, three months later, and at the end of the intervention and 3-month follow-up
Method of measurement
High-Risk Behavior Scale (YRBS)

2

Description
Cognitive regulation of emotion
Timepoint
Cognitive emotion regulation will be measured at three time points: before the intervention, at the end of the intervention, and at the 3-month follow-up
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ):

Intervention groups

1

Description
Intervention group:The intervention will consist of 12 weekly sessions of CBT for adolescents with high-risk behaviors in Ahvaz city, focusing on rebuilding shame and guilt beliefs, training in emotion regulation, and impulse control. The experimental group will receive this intervention, while the control group will only receive routine monitoring. Outcomes will be assessed in three stages: pre-test, post-test, and 3-month follow-up. All sessions will be delivered by trained therapists in selected centers in Ahvaz.
Category
N/A

2

Description
Control group: The control group in this study will not receive any active intervention and will only be monitored by the counseling centers as usual (such as general support sessions without a structured CBT protocol). After the study ends, this group will be given the opportunity to receive the CBT intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Unit
Full name of responsible person
Shams Sobhani Joo
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
Shams Sobhani Joo
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 61 3334 8420
Email
info@iauahvaz.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shams Sobhani Joo
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 61 3334 8420
Email
info@iauahvaz.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nilofar Raessi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 27, Ferdows 3 Complex, Anousheh Corner, Hejat Street, Zeyton Karmandi
City
Ahvaz
Province
Khouzestan
Postal code
6163917576
Phone
+98 61 3461 3512
Fax
Email
nilofarraessi@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
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
Loading...