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IRCT20250927067383N2 IRCT 2026-01-04 Persian gulf university Effectiveness of Mindfulness-Based Cognitive Therapy on Planning, Sustained Attention, and Cognitive Flexibility in Adults with Attention-DeficitHyperactivity Disorder Effectiveness of Mindfulness-Based Cognitive Therapy on Planning, Sustained Attention, and Cognitive Flexibility in Adults with Attention-DeficitHyperactivity Disorder 2026-02-16 anticipated 40 Complete https://irct.ir/trial/88316 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: no, Randomization description: After entering the screening and entry conditions, participants will be randomly assigned to two groups: "Mindfulness-Based Cognitive Therapy (MBCT)" and "Waiting List Control". The randomization method is simple randomization (simple randomization) and the randomization unit is considered to be individual (individual level). This means that each participant will be independently placed in one of the two groups. The allocation sequence will be created using SPSS software and the Random Number Generator function. The final list of allocations will be prepared by an independent researcher who has no intervention in the evaluation process. For allocation concealment, the group codes (A and B) will be placed in opaque and sealed envelopes and the envelopes will be opened in order based on the sequence of companies' arrival to minimize the possibility of bias in allocation. The assessors of the tests (TOL, CPT, WCST) will be blinded to the company grouping. Stratified randomization (stratified randomization) is not used in this study because the sample size was limited and population characteristics (gender, age) are matched between groups, Blinding description: Due to the nature of the group-based psychological intervention (MBCT) and the inclusion of a waitlist control group, blinding of participants and the therapist to group allocation will not be feasible. Participants will be directly aware of whether they are receiving the therapeutic sessions or are assigned to the waitlist, and the therapist will naturally be aware of delivering the intervention. However, to minimize assessment bias, blinding will be implemented at the level of outcome assessors and/or data analysts. Participants: Prior to enrollment, all participants will be provided with a full explanation of the study objectives, procedures, group conditions (MBCT intervention versus waitlist control), and the assessment schedule. Written informed consent will be obtained. Therefore, participants will not be blinded. Interventionist/Therapist: MBCT sessions will be delivered by a licensed therapist. Given the therapist’s direct role in administering the intervention, blinding will not be possible. Principal Investigator and Research Team: The principal investigator will be involved in study processes (e.g., study design, supervision of implementation, coordination of sessions) and, due to the operational nature of the trial, will be aware of group allocation. To reduce potential bias, the principal investigator will not be directly involved in outcome assessments. Data Collectors and Outcome Assessors: Cognitive assessments, including the Tower of London (TOL), Continuous Performance Test (CPT), and Wisconsin Card Sorting Test (WCST), will be administered at all three time points (pre-test, post-test, and follow-up) by trained assessors who will be blinded to group allocation. To maintain blinding, group assignment will not be recorded on assessment forms, and participants will be instructed to refrain from disclosing their treatment status during testing. N/A Attention-deficit hyperactivity disorders. Intervention 1: Intervention Group: Mindfulness-Based Cognitive Therapy (MBCT)Participants assigned to the intervention group will receive Mindfulness-Based Cognitive Therapy (MBCT) in a group format. The intervention will be delivered by a trained and licensed therapist in accordance with the standard MBCT protocol. The program will consist of eight in-person group sessions, each lasting approximately 90 minutes, and will be conducted on a weekly basis.Each session will include the following components:Instruction in core mindfulness concepts, with an emphasis on awareness of the present moment.Formal mindfulness practices, including body scan, focused breathing, and mindfulness of movement (e.g., simple stretching exercises).Brief daily-life practices aimed at increasing awareness of thoughts, emotions, and bodily sensations in real-world situations.Cognitive components targeting the identification of automatic thoughts, nonjudgmental observation of thoughts, and reduction of engagement with ruminative thinking.Training in strategies for managing distraction and redirecting attention back to the target stimulus.Participants will be assigned homework exercises, consisting of daily mindfulness practice lasting 20–30 minutes, with completion documented using structured practice logs. Attendance and active participation will be monitored throughout the intervention period, and the intervention will be delivered in a standardized and uniform manner to all participants in this group. Intervention 2: Control group: Waitlist control group without any intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality
public Leila Kamran
Bahmani
Bushehr Iran (Islamic Republic of) ۷۵۱۶۹۱۳۸۱۷ +98 917 001 8657 l.kamran92@gmail.com Persian Gulf University scientific Leila Kamran
Bahmani
Bushehr Iran (Islamic Republic of) ۷۵۱۶۹۱۳۸۱۷ +98 917 001 8657 l.kamran92@gmail.com Persian Gulf University Iran (Islamic Republic of) Age 18–40 years and Provision of written informed consent Willingness to attend sessions regularly Absence of active psychotic disorders or neurological conditions ADHD eligibility was established via clinical interview and DSM-5-TR criteria (American Psychiatric Association, 2022) and a Barkley-based diagnostic procedure, such that the presence of ≥3 symptoms in either the inattention domain or the hyperactivity–impulsivity domain, and ≥5 symptoms on the total ADHD index will consider clinically meaningful. 18 years 40 years Both Missing more than two treatment sessions Initiation of, or substantial change in, concurrent pharmacotherapy or psychotherapy during the study period; Emergence of acute clinical conditions (e.g., manic episode or psychotic symptoms) that interfered with continuing the intervention Withdrawal from the study or failure to complete post-test or follow-up assessments. F90 Attention-deficit hyperactivity disorders Treatment - Other Other Intervention Group: Mindfulness-Based Cognitive Therapy (MBCT)Participants assigned to the intervention group will receive Mindfulness-Based Cognitive Therapy (MBCT) in a group format. The intervention will be delivered by a trained and licensed therapist in accordance with the standard MBCT protocol. The program will consist of eight in-person group sessions, each lasting approximately 90 minutes, and will be conducted on a weekly basis.Each session will include the following components:Instruction in core mindfulness concepts, with an emphasis on awareness of the present moment.Formal mindfulness practices, including body scan, focused breathing, and mindfulness of movement (e.g., simple stretching exercises).Brief daily-life practices aimed at increasing awareness of thoughts, emotions, and bodily sensations in real-world situations.Cognitive components targeting the identification of automatic thoughts, nonjudgmental observation of thoughts, and reduction of engagement with ruminative thinking.Training in strategies for managing distraction and redirecting attention back to the target stimulus.Participants will be assigned homework exercises, consisting of daily mindfulness practice lasting 20–30 minutes, with completion documented using structured practice logs. Attendance and active participation will be monitored throughout the intervention period, and the intervention will be delivered in a standardized and uniform manner to all participants in this group. Control group: Waitlist control group without any intervention Planning. Timepoint: Pre-test, post-test, immediately after treatment, follow-up 2 months after treatment. Method of measurement: Final score on the Tower of London benchmark test. Sustained attention. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Omission errors in CPT. Wisconsin Card Sorting. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Number of categories completed on the Wisconsin Card Sorting Test (WCST). NO. Timepoint: NO. Method of measurement: NO. Persian gulf university Approved 2025-08-12 Bushehr University of Medical Sciences Bahmani street Bushehr Boushehr Iran (Islamic Republic of)