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IRCT20250927067383N1 IRCT 2025-10-07 Persian Gulf University Effectiveness of Cognitive-Behavioral and Mindfulness-Based Therapies in Adults with Attention-Deficit/Hyperactivity Disorder Comparative Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy on Executive Functions, Cognitive Disengagement Syndrome, Stress Management, and Quality of Life in Adults with ADHD 2024-09-22 anticipated 60 Complete https://irct.ir/trial/86503 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, 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 Attention deficit hyperactivity disorder. Intervention 1: Intervention group: Cognitive-behavioral therapy. Intervention 2: Control group: No intervention was performed. Intervention 3: Intervention group: Mindfulness-based cognitive therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is To maintain confidentiality
public Leila Kamran
Bushehr, Persian Gulf Street, Persian Gulf University
Bushehr Iran (Islamic Republic of) 7516913817 0773122 l.kamran92@gmail.com Persian Gulf University scientific Leila Kamran
Bushehr, Persian Gulf Street, Persian Gulf University
Bushehr Iran (Islamic Republic of) 7516913817 0773122 l.kamran92@gmail.com Persian Gulf University Iran (Islamic Republic of) Age 18- 40 years old Sufficient motivation 18 years 40 years Both History of neurological disorders Color blindness Lack of computer knowledge F90 Attention-deficit hyperactivity disorders Treatment - Other Treatment - Other Treatment - Other Intervention group: Cognitive-behavioral therapy Control group: No intervention was performed. Intervention group: Mindfulness-based cognitive therapy Inattention score measured by the Barkley Adult ADHD Rating Scale-IV (BAARS-IV).Hyperactivity score measured by the BAARS-IV.Impulsivity score measured by the BAARS-IV.Sluggish Cognitive Tempo (SCT) score measured by the BAARS-IV and performance-based tests.Cold executive functions (cognitive flexibility, sustained attention, response inhibition, planning) measured by the Wisconsin Card Sorting Test (WCST), Stroop Test, Tower of London, and Continuous Performance Test (CPT).Hot executive functions (emotion regulation and decision-making) measured by related questionnaires and decision-making tasks.Quality of life measured by the Adult ADHD Quality of Life Questionnaire (AAQoL).Stress management measured by the Depression Anxiety Stress Scales (DASS-21). Timepoint: Pre-test before the intervention begins, post-test immediately after the end of the treatment sessions, and follow-up 2 months after the end of treatment. Method of measurement: Barclay Adult Attention-Deficit Hyperactivity Disorder Rating Scale, Adult ADHD Quality of Life Scale (AAQoL), Depression-Anxiety-Stress Scale (DASS), Stroop test, Wisconsin Card Sorting Test, Tower of London Test, Continuous Performance Test (CPT). Persian Gulf University Approved 2025-08-12 Bushehr University of Medical Sciences Asadabadi Street, Alley 3, Parsam Building, Unit 8 Shiraz Fars Iran (Islamic Republic of)