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IRCT20250927067383N3 IRCT 2026-01-19 Persian gulf university The Impact of Mindfulness-Based Cognitive Therapy (MBCT) on the Executive Functions of adults with Cognitive Disengagement Syndrome The Impact of Mindfulness-Based Cognitive Therapy (MBCT) on the Executive Functions of adults with Cognitive Disengagement Syndrome 2026-01-10 anticipated 40 Complete https://irct.ir/trial/88550 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method of this study is multi-stage cluster random sampling, and the assignment of subjects to groups is also random. 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: Participants: Individuals enrolled in the study were aware of the type of treatment they were receiving (cognitive-behavioral or cognitive-mindfulness), but were not accurately informed of the existence of a control group and between-group comparisons to reduce the expectation effect. Principal Investigator: The principal investigator, who was responsible for data analysis, was not aware of the coding of groups (A, B, and C) until the end of data collection, and analyses were conducted as anonymous data. Therapists: Due to the nature of psychological interventions, therapists were aware of the type of intervention they were implementing and there was no possibility of blinding them. Healthcare personnel: Because the intervention was implemented in an academic setting and by a trained researcher, clinical personnel had no involvement in the treatment and care of participants. Data collectors and outcome assessors: The individuals who collected and scored the questionnaires were unaware of the type of intervention and the grouping of participants. The questionnaires were delivered and analyzed with only the participants' anonymous codes (without mentioning the treatment group). Authors of the final report: The initial writing of the article was done based on the coded data (without disclosing the groups) and only after the statistical analyses were completed, the group codes were opened and the results were interpreted accordingly. N/A Cognitive Disengagement Syndrome. 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 Privacy
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 willingness to attend sessions regularly absence of neurological disorders or active psychotic conditions normal intellectual functioning based on student health records 18 years 40 years Both color blindness lack of basic computer skills concurrent psychotropic medication or psychological treatment comorbid attention-deficit/hyperactivity disorder 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). Stroop test. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Interference score. Persian gulf university Approved 2025-08-12 Bushehr University of Medical Sciences Bahmani street Bushehr Boushehr Iran (Islamic Republic of)