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IRCT20240823062845N1 IRCT 2024-09-04 Iran University of Medical Sciences Comparison of the effectiveness of transdiagnostic cognitive-behavioral therapy (TCBT) with mindfulness-based therapy (MBT) in reducing symptoms and comorbid problems of adolescents with attention deficit hyperactivity disorder (ADHD) Comparison of the effectiveness of transdiagnostic cognitive-behavioral therapy (TCBT) with mindfulness-based therapy (MBT) in reducing symptoms and comorbid problems of adolescents with attention deficit hyperactivity disorder (ADHD) 2024-08-26 anticipated 30 Complete https://irct.ir/trial/78664 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will employ a simple randomization method to assign participants to two intervention groups. Simple randomization is chosen due to its appropriateness for the small sample size and its ability to provide unbiased assignment of participants to study groups. The unit of randomization will be the individual participant. Each eligible participant will be randomly assigned to MBCT group or the TCBT. The study will include a total of 30 participants, with 15 participants allocated to each of the two intervention groups. The randomization process will utilize the Random Allocation Software, a free Windows-based program specifically designed for randomization in clinical trials.The randomization will be conducted as follows: The Random Allocation Software will be downloaded from the official website (https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) and installed on a computer. Within the software, two intervention groups will be specified: MBCT and TCBT. The total sample size of 30 will be entered into the software. The "Only one block" option will be selected to ensure simple randomization. The randomization sequence will be generated using the software's built-in random number generator. To maintain allocation concealment and prevent selection bias, the randomization sequence will be generated by a researcher not involved in participant recruitment or assessment, Blinding description: In this study, we will implement a partial blinding approach, specifically focusing on blinding the outcome assessor and data analyzer. This strategy is designed to minimize detection and analysis bias while acknowledging the practical limitations of blinding other parties involved in the study. Participants and healthcare providers will not be blinded to the treatment allocation. This is due to the nature of the interventions (MBCT and TCBT), which require active participation and specific therapeutic techniques that cannot be concealed from those delivering or receiving the treatment. The principal investigator will not be blinded to group allocation, as they will be overseeing the overall conduct of the study and ensuring proper implementation of both interventions. N/A attention deficit hyperactivity/impulsivity disorder. Intervention 1: The first intervention group: transdiagnostic cognitive-behavioral therapy. For this group, the unified protocol of transdiagnostic cognitive-behavioral therapy of Barlow et al. (2017) will be used. This intervention will include 20 individual treatment sessions, each of which will last 45 minutes. Specifically, the goal of this protocol is reducing the intensity and frequency of negative emotions. Unified protocol is designed to accomplish this goal through emotion-focused education, awareness techniques, cognitive strategies, problem-solving and an array of behavioral strategies, including a full-range of exposure and activation techniques. Intervention 2: The second intervention group: mindfulness-based therapy. The mindfulness protocol developed by Zylowska and Mitchell (2021) for individuals with ADHD will be applied to this intervention group. This approach involves 20 individual sessions, each lasting 45 minutes. The protocol aims to achieve three primary objectives: Disengaging from autopilot mode, enhancing attentional control and self-monitoring and cultivating a new perspective on internal experiences. These goals are achieved through teaching a variety of formal and informal mindfulness techniques, including mindfulness of thoughts, sounds, breathing, movement, kindness meditation, mindful listening and speaking and etc. Yes - There is a plan to make this available What will be shared: The data entered in the statistical software in the form of SPSS file will be shared to the public through Figshare with a dedicated URL in the Data availability statement section. which according to the data dictionary should also be attached. Also, the results of the statistical analysis performed by the SPPS software will be available to the readers of the article. The study protocol will be attached to the article. When: The access time will be immediately after the results are printed. To whom: All people who are readers of the mentioned study. Conditions: The mentioned data can be compared with the results of other studies. Also, these data will be available for meta-analyses. Where to obtain: The data can be accessed in the form of attached files and internet addresses from figshare, which will be mentioned in the article itself. How to obtain: The data will be provided with the article and there is no need to send a direct request to the authors. Comments:
public Maryam Sadighpour
Tawanir St. Vali Amr Square. The end of Yousefzadeh alley. Golha building
Tabriz Iran (Islamic Republic of) 5155755386 +98 41 3658 1941 maryamsadighpour1370@gmail.com Iran University of Medical Sciences scientific Maryam Sadighpour
Tawanir St. Vali Amr Square. The end of Yousefzadeh alley. Golha building
Tabriz Iran (Islamic Republic of) 5155755386 +98 41 3658 1941 maryamsadighpour1370@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Adolescent with attention deficit hyperactivity disorder receiving a fixed dose of the drug from at least one month before the start of the study age 14-17 14 years 17 years Both Being diagnosed with bipolar mood disorder Being diagnosed with psychotic disorders Being diagnosed with substance use disorder Having serious suicidal thoughts Being diagnosed with conduct disorder F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Other Treatment - Other The first intervention group: transdiagnostic cognitive-behavioral therapy. For this group, the unified protocol of transdiagnostic cognitive-behavioral therapy of Barlow et al. (2017) will be used. This intervention will include 20 individual treatment sessions, each of which will last 45 minutes. Specifically, the goal of this protocol is reducing the intensity and frequency of negative emotions. Unified protocol is designed to accomplish this goal through emotion-focused education, awareness techniques, cognitive strategies, problem-solving and an array of behavioral strategies, including a full-range of exposure and activation techniques. The second intervention group: mindfulness-based therapy. The mindfulness protocol developed by Zylowska and Mitchell (2021) for individuals with ADHD will be applied to this intervention group. This approach involves 20 individual sessions, each lasting 45 minutes. The protocol aims to achieve three primary objectives: Disengaging from autopilot mode, enhancing attentional control and self-monitoring and cultivating a new perspective on internal experiences. These goals are achieved through teaching a variety of formal and informal mindfulness techniques, including mindfulness of thoughts, sounds, breathing, movement, kindness meditation, mindful listening and speaking and etc. Symptoms of attention deficit and hyperactivity/impulsivity based on Connors parent questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Connors parent questionnaire. Symptoms of attention deficit and hyperactivity/impulsivity based on the integrated visual and auditory continuous performance test. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: integrated visual and auditory continuous performance test. Anxiety intensity. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Beck anxiety inventory. Severity of depression. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Beck depression inventory. Severity of emotional dysregulation. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Reactivity, intensity, polarity and stability scale. Iran University of Medical Sciences Approved 2023-10-23 Research Ethics Committees of Iran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. tehran Tehran Iran (Islamic Republic of)