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IRCT20240227061119N1 IRCT 2024-07-23 The University of Kurdestan The Effectiveness of Unified Protocol for Transdiagnostic Treatment on people with Separation Anxiety Disorder The Effectiveness of Unified Protocol for Transdiagnostic Treatment on Symptoms and Emotional and Cognitive indices of Adults with Separation Anxiety Disorder Comorbid with Emotional Disorders: A Randomized Controlled Trial 2024-07-10 anticipated 34 Complete https://irct.ir/trial/76306 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants with SAD and comorbid emotional disordes will assigne to treatment groups and wait- list group on the basis of covariate adaptive randomization (minimisation). The purpose of this method is to control gender variable. So if the first participant be female, she will assigne in group number one. When the second participant be a man, he will assigne in the first group. When the third participant be female, she will assigne to the second group. If the fourth participant be female, she will assigne to third group and then the rest of the participants will place in the groups by adjusting the gender variable, Blinding description: Interviews will conduct by an expert clinical therapist to assess the inclusion and exclusion criteria. After that, individuals randomly will assign to treatment group and wait- list group. Allocation of participants, will administer by someone other than therapist. N/A Adult separation anxiety disorder. Intervention 1: Intervention group: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies. Intervention 2: Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1. Yes - There is a plan to make this available What will be shared: Part of the data including information about the main consequence can be shared. When: Start of accessibility will be one year after printing the results. To whom: Data will only be available to researchers working in academic institutions. Conditions: Requests for data are only permitted for intercultural studies or the studies of meta-analysis. Where to obtain: Researchers can use the mentioned communication channel to receive the desired documents or data. Email: f.nasiri@uok.ac.ir How to obtain: Data will be provided by email or post after evaluation of the request. Comments:
public Saeideh Sobhani
No. 61, In front of Takhti Club., Nizam-ul-Mulk Ave., South Montazeri Ave
Najafabad Iran (Islamic Republic of) 8517718844 +98 31 4261 7092 saeideh.sobhani@uok.ac.ir The University of Kurdestan scientific Farzad Nasiri
University of Kurdistan., Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 66177-15175 087-33664601-2246 f.nasiri@uok.ac.ir University of Kurdistan Iran (Islamic Republic of) Having the diagnostic criteria DSM-5-TR for separation anxiety disorder and comorbid emotional disorders, and not taking drugs related to disorder. Consent to participate in the research Being at least 18 years old Having at least a diploma Not receiving any type of treatment related to the disorder during the past year Speak Persian fluently Ability to participate in all assessment and treatment sessions 18 years 50 years Both Receiving any other type of psychological treatment Having any type of personality disorder and diagnosing any type of psychiatric disorder (except for emotional disorders) Substance abuse Having serious thoughts about Suicide Taking medications related to disorders Treatment - Other Treatment - Other Intervention group: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies. Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1. Separation anxiety score in adult separation anxiety questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Adult Separation Anxiety Questionnaire (ASA-27). Cognitive fusion score in cognitive fusion questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Cognitive fusion Questionnaire (CFQ). Anxiety sensitivity score in anxiety sensitivity questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Anxiety Sensitivity Questionnaire (ASI). Intolerance of uncertainty score in intolerance of uncertainty questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Intolerance Uncertainty Questionnaire (IUS). Emotion regulation score in the emotion regulation difficulty scale. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Difficulties Emotion Regulation scale (DERS). Anxiety score in dass21 questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Dass21 questionnaire. Depression score in dass21 questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Dass21 questionnaire. The University of Kurdestan Approved 2024-04-27 Ethics committee in biological research Central organization., University of Kurdistan., Pasdaran Blvd Sanandaj Kurdistan Iran (Islamic Republic of)