Protocol summary

Study aim
Determining the Effectiveness of and Comparing Emotion-Focused Therapy and Adolescent-Centered Mindfulness Training on Cognitive Fusion and Self-Concept in Adolescent Girls Prone to Risky Behaviors
Design
A randomized, single-blind, parallel-group, controlled clinical trial conducted on 60 participants.
Settings and conduct
Research setting: selected girls' secondary schools Collection of baseline data within the school environment. The students were unaware of the implementation procedure. Members of the two groups—the intervention group and the control group—came from three different schools and did not know one another.
Participants/Inclusion and exclusion criteria
Inclusion criteria : being female; enrollment in an upper secondary school during the academic year in which the study was conducted; engagement in one or more high-risk behaviors; no prior participation in similar workshops or educational classes; absence of psychiatric disorders or concurrent therapeutic interventions; provision of informed consent to participate; and achieving a score equal to or greater than the cutoff score of 95 on the Iranian Adolescent Risk-Taking Questionnaire—used as the primary criterion for identifying eligible participants. It should be noted that meeting this criterion indicates that the participant exhibits a significant level of propensity toward high-risk behaviors, as assessed by the screening instrument. Exclusion criteria: Inability to attend the 8 educational sessions or absence from more than two sessions; dissatisfaction with the sessions at any stage of the study; failure to cooperate with therapeutic assignments; and the use of psychiatric medications or receipt of concurrent therapeutic interventions.
Intervention groups
Emotion-Focused Therapy Intervention Group Adolescent-Focused Mindfulness Training Intervention Group
Main outcome variables
Cognitive Fusion Self-Concept

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20261018071474N1
Registration date: 2026-11-02, 1405/08/11
Registration timing: registered_while_recruiting

Last update: 2026-11-02, 1405/08/11
Update count: 0
Registration date
2026-11-02, 1405/08/11
Registrant information
Name
mahdiyeh Pakdaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3172 3525
Email address
mahdiyeh.pakdaman@iau.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-26, 1405/08/04
Expected recruitment end date
2026-11-25, 1405/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Emotion-Focused Therapy and Adolescent- Centered Mindfulness Training on Cognitive Fusion and Self-Concept Of Girls with High Risk Behaviors tendencies
Public title
Comparing the Effectiveness of Emotion-Focused Therapy and Adolescent- Centered Mindfulness Training on Cognitive Fusion and Self-Concept Of Girls with High Risk Behaviors tendencies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
being female being enrolled in upper secondary school during the academic year in which the research was conducted, engaging in at least one (or more) high-risk behavior(s) provide consent and score at or above the cutoff point of 95 on the Iranian Adolescent Risk-Taking Questionnaire having no psychiatric disorders or concurrent therapeutic interventions. participants were required to —a primary criterion for identifying eligible candidates Consent to participate in the research
Exclusion criteria:
I use of psychiatric medications receipt of concurrent therapeutic interventions. Unwillingness to participate in research
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Step 1: To select girls' upper secondary schools, three schools are chosen using a non-random, purposive sampling method. Phase Two: Screening and identification of eligible students (those scoring at or above the cut-off score of 95 on the Iranian Adolescent Risk-Taking Questionnaire) in selected schools. A total of 60 eligible students will be selected from 3 designated schools (20 students from each school). Step 3: Following the traditional lottery method, each of the selected schools is assigned a number. The selection of 60 eligible students—to be placed into the experimental and control groups—is carried out by randomly drawing a number from a container.
Blinding (investigator's opinion)
Single blinded
Blinding description
This task was carried out by the researcher and the instructor of the two interventions. The participants in this study, who were students, were unaware of the details. Each of the group intervention sessions was conducted in two separate schools at different times by a single therapist (trained in the research interventions), and the members of the two experimental groups did not know one another.Members of the control group were also selected from a separate school. To minimize the risk of cross-contamination between the interventions, the two treatment groups were organized separately, and the sessions for each intervention were conducted in independent groups. Throughout the implementation of the interventions, members of each group remained unaware of the content of the other group’s sessions; furthermore, they were instructed not to share the session content or the activities performed with students outside their own group. Additionally, the sessions for the two interventions were held at different times, and participants were assigned to their respective groups prior to the commencement of the intervention. Given that the participants were drawn from the same school community, the potential for interaction and the exchange of information among students—a possible source of contamination—was taken into account; this risk was mitigated as much as possible by conducting the sessions separately and emphasizing the confidentiality of the session content.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee, Islamic Azad University, Ardabil Branch
Street address
Basij Square
City
Ardabil
Province
Ardabil
Postal code
: ۵۶۱۵۷۳۱۵۶۷
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.IAU.ARDABIL.REC.1404.235

Health conditions studied

1

Description of health condition studied
High Risk Behaviors tendencies
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive Fusion
Timepoint
Pre-test, post-test, 3-month follow-up
Method of measurement
Gillanders Cognitive Fusion Test

2

Description
Self-Concept
Timepoint
Pre-test, post-test, 3-month follow-up
Method of measurement
Beck Self-Concept Test

Secondary outcomes

empty

Intervention groups

1

Description
Emotion-Focused Therapy will be conducted in a group format over eight weekly, 60-minute sessions. The protocol is based on the book *Emotion-Focused Therapy in Practice* (Elliott & Greenberg, 2021; translated by Ramezani et al., 2024).
Category
Treatment - Other

2

Description
Adolescent-focused mindfulness training will be conducted in a group format over eight 60-minute weekly sessions. The protocol is based on the *Mindfulness Skills Training Manual for Children and Adolescents* (Burdick, 2014; translated by Monshi et al., 2021).
Category
Treatment - Other

3

Description
Control group: Without intervention and on the waiting list
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaffari School
Full name of responsible person
Mahdiyeh Pakdaman
Street address
Shohada Avenue Shahid Eftekhari Alley
City
Fuoman
Province
Guilan
Postal code
4351739133
Phone
+98 13 3172 3525
Email
mahdiyeh.pakdaman@gmail.com

2

Recruitment center
Name of recruitment center
Ziynabiyeh School
Full name of responsible person
Mahdiyeh Pakdaman
Street address
Shohada Avenue Shahid Eftekhari Alley
City
Fuoman
Province
Guilan
Postal code
4351739133
Phone
+98 13 3172 3525
Email
mahdiyeh.pakdaman@gmail.com

3

Recruitment center
Name of recruitment center
Sommayeh School
Full name of responsible person
Mahdiyeh Pakdaman
Street address
Shohada Avenue Shahid Eftekhari Alley
City
Fuoman
Province
Guilan
Postal code
4351739133
Phone
+98 13 3172 3525
Email
mahdiyeh.pakdaman@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research and Technology, Islamic Azad University, Ardabil Branch
Full name of responsible person
Dr Ali Mansuri
Street address
Ardabil – Basij Square – Islamic Azad University, Ardabil Branch Complex
City
Ardabil
Province
Ardabil
Postal code
3156757561
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
info@iauardabil.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy for Research and Technology, Islamic Azad University, Ardabil Branch
Proportion provided by this source
10
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mahdiyeh Pakdaman
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shohada Avenue - Shahid Eftekhari Alley
City
Fuman
Province
Ardabil
Postal code
4351739133
Phone
+98 13 3172 3525
Email
mahdiyeh.pakdaman@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Ardabil Branch
Full name of responsible person
Dr Reza Kazemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Basij Square
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۵۷۳۱۵۶۷
Phone
0989141525726
Email
rezak.kazemi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mahdiyeh Pakdaman
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shohada Avenue , Shahid Eftekhari Alley
City
Fouman
Province
Guilan
Postal code
4351739133
Phone
+98 13 3172 3525
Email
mahdiyeh.pakdaman@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
Not applicable
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
Participants' data and scores will be recorded in an Excel file and subjected to statistical analysis; the results of this analysis will be published in the doctoral dissertation and as a research article.
When the data will become available and for how long
After the work is finished
To whom data/document is available
Principal Investigator, Supervisors, and Advisors, Supervisors, and Advisors
Under which criteria data/document could be used
Publishing research results
From where data/document is obtainable
Principal Investigator Mahdiyeh Pakdaman Contact Number 00989113363596
What processes are involved for a request to access data/document
Contacting the principal researcher to receive guidance on obtaining data and data analysis results, within a maximum period of 2 months.
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