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IRCT20200111046085N1 IRCT 2026-11-05 Urmia University Comparison of the Effectiveness of a Cognitive Therapy Package Targeting Prefrontal Cortex Functions Versus a Control Group on Executive Functions and Academic Self-Regulation in Adolescents with Internet Addiction Development and Validation of an Artificial Intelligence-Assisted Cognitive Therapy Package for Enhancing Prefrontal Cortex Functions and Evaluating Its Effectiveness on Executive Functions and Academic Self-Regulation in Adolescents with Internet Addiction 2026-11-07 anticipated 50 Recruiting https://irct.ir/trial/93917 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This clinical trial represents the quantitative effectiveness-evaluation phase of a multistage study aimed at developing, validating, and evaluating a cognitive therapy package. Following package development and content validation by experts, the effectiveness of the finalized intervention will be assessed in a two-arm parallel-group randomized controlled trial. Outcomes will be assessed at three time points: baseline, post-intervention, and two-month follow-up. The intervention comprises 12 weekly group sessions, each lasting 90 minutes, preceded by a separate 30–45-minute orientation session for a parent or legal guardian. Artificial intelligence will be used solely as a supervised support tool for predefined exercises and homework tasks. It will not replace the therapist or function as an independent clinical decision-maker. The control group will continue to receive usual educational, behavioral, and counseling services at school, and the cognitive therapy package will be offered to the control group after completion of follow-up, in accordance with the study protocol, Randomization description: Participants will be allocated to the study groups using block randomization with variable block sizes. The unit of randomization will be the individual participant. After screening, verification of eligibility criteria, obtaining written informed consent from a parent or legal guardian and informed assent from the adolescent, and completion of baseline assessments, eligible participants will be allocated in a 1:1 ratio to the intervention and control groups. The target sample size is 50 participants, with 25 participants in each group. The random allocation sequence will be generated using the online Sealed Envelope tool, with variable block sizes of 4 and 6 participants. Before allocation begins, the generated sequence will be checked to ensure that the final list contains 50 allocations, with exactly 25 assignments to each group. If necessary, a new sequence will be generated using the same settings and a new random seed and will be checked again. The final random seed, output file, and date of sequence generation will be documented and retained. Stratified randomization will not be used. To ensure allocation concealment, the complete allocation sequence and assignment order will be held by a person independent of participant screening and enrollment. Preferably, each allocation will be placed in an opaque, sealed, sequentially numbered envelope. The envelope for each participant will be opened only after final eligibility has been confirmed, informed consent and assent have been obtained, and baseline assessments have been completed. This procedure is intended to prevent knowledge of the anticipated group assignment from influencing participant selection and enrollment. N/A Internet Addiction (Problematic Internet Use, defined as a score of 50 or higher on Young’s Internet Addiction Test [IAT]). Intervention 1: Intervention group: Intervention Group: Artificial Intelligence-Assisted Cognitive Therapy Targeting Prefrontal Cortex Functions Participants in this group will receive the developed and validated cognitive therapy package assisted by artificial intelligence in 12 group sessions. The intervention is designed to enhance cognitive and executive processes and improve academic self-regulation. Artificial intelligence will be used only as a supervised support tool for pre-approved activities and exercises and will not replace the therapist. Intervention 2: Control group: Control Group: Usual School Educational Activities Participants in this group will not receive the study cognitive therapy package during the intervention period and will continue their usual school educational activities. After completion of the study and data collection, the educational materials or cognitive therapy package may also be made available to them, subject to their interest and coordination with school authorities. Yes - There is a plan to make this available What will be shared: Controlled Access to De-identified Individual Participant Data and Supporting Study Documents The study data and documentation may be shared upon an approved request. The materials may include the de-identified individual participant dataset, covering the study variables and assessment time points; the study protocol; the statistical analysis plan; blank informed consent and adolescent assent forms; the final clinical study report; the data dictionary; and analysis code or syntax, where available. Direct personal identifiers will not be shared. Before any data are transferred, indirect identifiers and the risk of re-identification will be assessed. Sensitive free-text information, private communications, and other information that could reasonably identify participants will be excluded or appropriately protected. Materials will be provided through controlled access rather than unrestricted public release. When: Access will begin 12 months after completion of the study or after publication of the primary study results, whichever occurs later, and will remain available for five years. Access will be granted on a request-by-request basis, subject to eligibility review, applicable ethical approvals, and the conditions described in this data-sharing plan. No unrestricted public download will be provided. To whom: Qualified researchers affiliated with recognized universities or research institutions, as well as competent ethics committees, regulatory authorities, or other legally authorized bodies acting within their official responsibilities, may submit a request. Applicants must demonstrate an appropriate institutional affiliation, professional competence, and a legitimate research, ethical oversight, or regulatory purpose. Access is not automatic and is subject to review and approval. Conditions: Data and documents may be used for legitimate scientific research, verification of reported findings, evidence synthesis, meta-analysis, and other secondary analyses consistent with the approved purpose and applicable ethical requirements. Each request must specify the research question, intended analyses, requested variables or documents, institutional affiliation, and data protection arrangements. Ethics committee approval or other authorization must be provided where required. Approved recipients must sign a data-use or data-sharing agreement, use the materials only for the approved purpose, protect them through appropriate security measures, refrain from attempting to identify or contact participants, and not transfer the materials to unauthorized third parties. Only the data and documents necessary and proportionate to the approved request will be released. Any sharing of individual participant data involving minors will additionally require confirmation that the proposed sharing is consistent with the applicable ethics approval and informed consent arrangements. Where to obtain: Requests should be addressed to Mahdi Chitsaz, PhD Candidate, Faculty of Literature and Humanities, University of Urmia, Urmia, West Azerbaijan Province, Iran. Email: mahdi.chitsaz77@gmail.com Postal Address: University of Urmia, Nazlu Campus, 11th Km, Sero Road, Urmia, West Azerbaijan Province, Iran. Applicants should provide details of the requested dataset or documents, their institutional affiliation, contact information, and a brief description of the intended purpose of use. Requests will be reviewed by the dissertation supervisors and the doctoral candidate in accordance with applicable institutional and ethical requirements. How to obtain: The applicant must submit a written request specifying the required data or documents, the research question, the planned analyses, the intended purpose, the applicant's institutional affiliation, and the relevant ethics approval or authorization, where applicable. The supervisors will assess the applicant's qualifications, the legitimacy of the scientific or official purpose, the appropriateness of the scope of the request, potential confidentiality risks, and the request's consistency with the study protocol, informed consent arrangements, ethics approvals, and relevant institutional requirements. A preliminary decision will normally be communicated to the applicant within 30 working days of receipt of a complete request. Additional time may be required if consultation with the relevant ethics committee or responsible institution is necessary. If the request is approved, the recipient must sign the applicable data-use or data-sharing agreement. The approved data or documents will normally be transferred securely within 15 working days after all required documentation and agreements have been completed. A request may be declined, restricted to a subset of the requested materials, or delayed until the relevant issues are resolved if the proposed access poses a risk to confidentiality or conflicts with applicable ethical, legal, or institutional requirements. The applicant will be informed of the decision and, where appropriate, the reasons for any restrictions. Comments: This plan is based on controlled access and does not constitute a commitment to unrestricted public disclosure of information. The Principal Investigator is willing to review reasonable and well-justified requests from qualified applicants seeking access to the study data and documentation, in accordance with the conditions described above. No direct personal identifiers or information that could reasonably lead to the identification of participants will be disclosed. Protecting the privacy of adolescent participants is a priority. Individual participant data will be shared only if such sharing is permitted by the ethics approval, informed consent arrangements, and relevant institutional requirements. If additional ethical approval or amendments to the approved informed consent arrangements are required, the necessary authorization must be obtained before the data are provided. The scope of data sharing will be determined based on the approved request, the principle of data minimization, confidentiality safeguards, and applicable ethical and legal requirements.
public Mahdi Chitsaz
Shahid Madani Street, Ramian Alley, No. 34
Azarshahr Iran (Islamic Republic of) 5371935198 +98 41 3422 2570 mahdi.chitsaz77@gmail.com Urmia University scientific Mahdi Chitsaz
Shahid Madani Street, Ramian Alley, No. 34
Azarshahr Iran (Islamic Republic of) 5371935198 +98 41 3422 2570 mahdi.chitsaz77@gmail.com Urmia University Iran (Islamic Republic of) Enrollment in Shahid Asadi Shahed Upper Secondary School in Azarshahr. Age between 15 and 18 years. Male sex. A score of 50 or higher on Young’s Internet Addiction Test (IAT), used as the operational screening and study-entry criterion. Provision of written informed assent by the adolescent to participate in the study. Provision of written informed consent by the parent or legal guardian. 15 years 18 years Male A severe psychiatric disorder at the time of screening, based on treatment records or a psychiatrist’s diagnosis. Current use of psychiatric medication that, in the judgment of the relevant specialist and the researcher, is likely to substantially affect the study outcomes. Behavior N/A Intervention group: Intervention Group: Artificial Intelligence-Assisted Cognitive Therapy Targeting Prefrontal Cortex Functions Participants in this group will receive the developed and validated cognitive therapy package assisted by artificial intelligence in 12 group sessions. The intervention is designed to enhance cognitive and executive processes and improve academic self-regulation. Artificial intelligence will be used only as a supervised support tool for pre-approved activities and exercises and will not replace the therapist. Control group: Control Group: Usual School Educational Activities Participants in this group will not receive the study cognitive therapy package during the intervention period and will continue their usual school educational activities. After completion of the study and data collection, the educational materials or cognitive therapy package may also be made available to them, subject to their interest and coordination with school authorities. Change in Total Impulsivity Score. The effect of the intervention on adolescents’ impulsivity will be evaluated by examining changes in the total impulsivity score from baseline to post-intervention and follow-up. Higher scores indicate greater impulsivity. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the total score of the Barratt Impulsiveness Scale, Eleventh Version, a thirty-item instrument. The total score ranges from 30 to 120, with higher scores indicating greater impulsivity. Change in Reward Responsiveness Score, as the operational measure of reward processing. The intervention effect will be evaluated by examining changes in reward responsiveness across the three assessment time points. Higher scores indicate greater responsiveness to rewarding stimuli. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the score of the five-item Reward Responsiveness subscale of the Behavioral Inhibition System and Behavioral Activation System Scales. The subscale score ranges from 5 to 20, with higher scores indicating greater responsiveness to rewarding stimuli. Change in Total Cognitive Control Score. The effect of the intervention on adolescents’ cognitive control will be evaluated by examining changes in the total effortful control score, used as the operational measure of cognitive control, from baseline to post-intervention and follow-up. Higher scores indicate greater effortful control and cognitive control. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the total score of the Effortful Control Scale derived from the revised Early Adolescent Temperament Questionnaire. The scale contains twenty items, with a total score range of 20 to 100. Higher scores indicate greater effortful control. Change in Total Cognitive Flexibility Score. The effect of the intervention on adolescents’ cognitive flexibility will be evaluated by examining changes in the total cognitive flexibility score from baseline to post-intervention and follow-up. Higher scores indicate greater cognitive flexibility. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the total score of the Cognitive Flexibility Inventory developed by Dennis and Vander Wal. The instrument contains twenty items rated on a seven-point response scale, with a total score range of 20 to 140. Higher scores indicate greater cognitive flexibility. Change in Total Moral Intelligence Score. The effect of the intervention on adolescents’ moral intelligence will be evaluated by examining changes in the total moral intelligence score from baseline to post-intervention and follow-up. Higher scores indicate higher moral intelligence. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the total score of the Moral Intelligence Adolescents Scale, a seventy-one-item instrument rated on a five-point response scale. The total score ranges from 71 to 355, with higher scores indicating higher moral intelligence. Change in Total Academic Self-Regulation Score. The effect of the intervention on adolescents’ academic self-regulation will be evaluated by examining changes in the total academic self-regulation score from baseline to post-intervention and follow-up. Higher scores indicate higher academic self-regulation. Timepoint: 1. Baseline, before the intervention begins; 2. immediately after completion of the twelve-session intervention; 3. two months after completion of the intervention. Method of measurement: Using the total score of the fourteen-item Academic Self-Regulation Questionnaire developed by Bouffard and colleagues. The instrument assesses cognitive and metacognitive strategies. The total score ranges from 14 to 70, with higher scores indicating higher academic self-regulation. Frequency and Types of Adverse Events During the Study: Participant safety will be assessed by recording the number and types of adverse events experienced or reported during the study, regardless of whether a causal relationship with the intervention is established. Events of interest include increased psychological distress, worsening conflict between the adolescent and a parent or guardian, unintended disclosure of private information, receipt of inappropriate or misleading content from the artificial intelligence system, and technical or safety incidents that interfere with the safe delivery of the intervention. The timing, type, severity or observable consequences of each event, actions taken, and outcome of any human referral will be documented. This outcome will be reported descriptively. Timepoint: Monitoring throughout the intervention sessions, with each adverse event recorded when observed or reported during the participant’s involvement in the study. Method of measurement: Using a researcher-developed Adverse Event Monitoring and Reporting Form documenting the timing and type of each event, its severity or observable consequences, initial actions taken, decisions regarding temporary interruption or continuation of the intervention, and the outcome of any human referral. Iran National Science Foundation (INSF) Urmia University Iran National Science Foundation (INSF) Approved 2026-09-08 Research Ethics Committees of Urmia University کیلومتر ۱۱ جاده سرو، پردیس نازلو، دانشگاه ارومیه Urmia West Azarbaijan Iran (Islamic Republic of)