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IRCT20250522065850N1 IRCT 2025-06-11 The University of Kurdistan The Effectiveness of Unified Protocol for Transdiagnostic Treatment in adults with attention-deficit/hyperactivity disorder comorbid with other emotional disorders. UP The Effectiveness of the Unified Protocol for Transdiagnostic Treatment on Improving Symptoms and Psychological and Neuropsychological Indices in Adults with Attention-Deficit/Hyperactivity Disorder Comorbid with other Emotional Disorders: a Clinical Trial Study 2025-06-15 anticipated 34 Complete https://irct.ir/trial/83805 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and emotional disorders are selected based on the inclusion and exclusion criteria, they will be assigned to the treatment and waitlist groups using the minimization method. The purpose of this method is to control for the gender variable. For example, if the first participant is female, she will be assigned to group one. If the second participant is male, he will also be assigned to group one. If the third participant is female, she will be assigned to group two, and the remaining participants will be allocated in the same way, ensuring that gender is balanced across the groups, Blinding description: A clinical interview will be conducted by a clinical specialist to assess the inclusion and exclusion criteria. After that, participants will be randomly assigned to the treatment group and the waitlist group. The allocation of participants will be carried out by someone other than the therapist. N/A Adult Attention-Deficit/Hyperactivity Disorder (ADHD). Intervention 1: Intervention group: Unified Protocol for Transdiagnostic Treatment. The unified protocol for transdiagnostic treatment for emotional disorders consists of up to 12 sessions of 45 minutes each. This treatment targets emotional experiences by fostering emotional awareness and cognitive flexibility; identifying emotion-driven behaviors and replacing them with adaptive behaviors; recognizing and preventing emotional avoidance; increasing awareness of and exposure to bodily sensations; and modulating and confronting emotions in context. Intervention 2: Control group: The waitlist group will receive the unified protocol for transdiagnostic treatment. After the intervention group's follow-up sessions are completed, the unified protocol for transdiagnostic treatment, similar to that of the first intervention group, will be administered to the waitlist group. Yes - There is a plan to make this available What will be shared: A portion of the data includes information related to the primary outcome that can be shared. When: The start of access will be one year after the publication of the results. To whom: The data will be accessible only to researchers employed at academic institutions. Conditions: Requests to use the data are only permitted for use in cross-cultural reviews or meta-analyses. Where to obtain: To obtain the documentation, they can contact via email at f.nasiri@uok.ac.ir. How to obtain: Data information will be provided to individuals via email or mail after the request has been evaluated. Comments:
public Maryam Khazaei Soltanabadi
Enghelab Blvd
Kangavar Iran (Islamic Republic of) 6741713337 +98 83 4816 2126 maryam.khazaei@uok.ac.ir The University of Kurdistan scientific Farzad Nasiri
University of Kurdistan, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R
Sanandaj Iran (Islamic Republic of) 6617715175 +98 87 3366 4604 f.nasiri@uok.ac.ir The University of Kurdistan Iran (Islamic Republic of) Having diagnostic criteria for Adult ADHD and a comorbid emotional disorder Age range of 18 to 35 years Full consent to participate in the research Not receiving other therapeutic interventions concurrently with the present study 18 years 35 years Both The presence of other psychological disorders and personality disorders except for the mentioned emotional disorders Absence from more than two therapy sessions Having a history of substance and psychotropic drug abuse F90 Attention-deficit hyperactivity disorders Treatment - Other Treatment - Other Intervention group: Unified Protocol for Transdiagnostic Treatment. The unified protocol for transdiagnostic treatment for emotional disorders consists of up to 12 sessions of 45 minutes each. This treatment targets emotional experiences by fostering emotional awareness and cognitive flexibility; identifying emotion-driven behaviors and replacing them with adaptive behaviors; recognizing and preventing emotional avoidance; increasing awareness of and exposure to bodily sensations; and modulating and confronting emotions in context. Control group: The waitlist group will receive the unified protocol for transdiagnostic treatment. After the intervention group's follow-up sessions are completed, the unified protocol for transdiagnostic treatment, similar to that of the first intervention group, will be administered to the waitlist group The ADHD score on the Adult ADHD Self-Report Scale (ASRS). Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Adult ADHD Self-Report Scale (ASRS). Depression score on the Beck Depression Inventory (BDI_II). Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Beck Depression Inventory (BDI_II). The anxiety score in the Beck Anxiety Inventory. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Beck Anxiety Inventory - BAI. Frustration tolerance score on the Harrington Frustration Discomfort Scale. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Harrington Frustration Discomfort Scale. Anxiety Sensitivity score in the Anxiety Sensitivity Index (ASI) questionnaire. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Anxiety Sensitivity score in the Anxiety Sensitivity Index (ASI) questionnaire. Emotion Regulation score on the Emotion Regulation Questionnaire (ERQ) by Gross. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Emotion Regulation Questionnaire (ERQ) by Gross. Response inhibition score on the Go/No-Go task. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Go/No-Go task. Risky decision-making score in the Iowa Gambling Task. Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Iowa Gambling Task. Sustained attention score in the Continuous Performance Test (CPT). Timepoint: Before treatment; after treatment; one months after the completion of treatment. Method of measurement: Continuous Performance Test (CPT). The University of Kurdistan Approved 2025-05-17 Ethics Committee in Biomedical Research University of Kurdistan, Organizational Central Building, Third Floor, Pasdaran Blvd., Sanandaj, Kurdistan Province, I.R. Sanandaj Kurdistan Iran (Islamic Republic of)