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IRCT20140929019334N1 IRCT 2019-01-08 Ferdowsi University of Mashhad Effectiveness of unified transdiagnostic treatment with and without transcranial direct current stimulation Cognitive, emotional and neuropsychological indices of generalized anxiety disorder: effectiveness of unified transdiagnostic treatment with and without transcranial direct current stimulation 2017-12-09 anticipated 45 Complete https://irct.ir/trial/27988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants with GAD and comorbid depression 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 groups (UP group and UP-tDCS group) and wait- list group. Allocation of participants, will administer by someone other than therapist. N/A Generalized anxiety disorder comorbid with depression. Intervention 1: Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 12, 60-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 with physical sensations, and facing with emotions in situations. The treatment is preceded by enhancing 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.2:UP-tDCS. In the UP-tDCS group, for two weeks until the end of the UP sessions, the tDCS will perform. The treatment consists of 10 daily sessions (except for weekends) with a direct current of 2.0 mA for 30-minute stimulation session. The 25 cm2 rubber electrodes will moistene with saline to reduce impedance. The cathode will place over the right dorsolateral prefrontal cortex (DLPFC). 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: Tel: 0098513-8805873, Fax: 0098-513-8783012 Email:nasiri@mail.um.ac.ir How to obtain: Data will be provided by email or post after evaluation of the request. Comments:
public Farzad Nasiri
Vakilabad Blvd; Ferdowsi University of Mashhad
Mashhad Iran (Islamic Republic of) ۹۱۷۷۹۴۸۹۷۴ +98 985138806914 nasiri@mail.um.ac.ir Ferdowsi University of Mashhad scientific Farzad Nasiri
Vakilabad Blvd; Ferdowsi University of Mashhad
Mashhad Iran (Islamic Republic of) ۹۱۷۷۹۴۸۹۷۴ +98 985138806914 nasiri@mail.um.ac.ir Ferdowsi University of Mashhad Iran (Islamic Republic of) Diagnostic DSM-V criteria for GAD as the primary diagnosis and depression disorder as a comorbid disorder If the drug was taken, it was possible to maintain the type and amount of the drug during the study period Be a minimum 18 years and a maximum 40 years old Patient's consent to participate in research and to sign written consent Speak Persian fluently Ability to participate in all assessment and treatment sessions 18 years 40 years Both Need for immediate medical treatment or the need for concurrent therapeutic interventions in such a way as to interfere with the treatment program Not having previous experience in at least eight sessions of treatment based on the cognitive-behavioural therapy in the last 5 years Having psychiatric disorders and substance abuse Current diagnosis of any mental disorder in the axes I and II, with the exception of GAD and depression Patient's opposition to collaboration at any time of research Having serious thoughts about Suicide History of experiencing other psychological treatments F41.1 Generalized anxiety disorder Treatment - Other Treatment - Other Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 12, 60-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 with physical sensations, and facing with emotions in situations. The treatment is preceded by enhancing 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.2:UP-tDCS. In the UP-tDCS group, for two weeks until the end of the UP sessions, the tDCS will perform. The treatment consists of 10 daily sessions (except for weekends) with a direct current of 2.0 mA for 30-minute stimulation session. The 25 cm2 rubber electrodes will moistene with saline to reduce impedance. The cathode will place over the right dorsolateral prefrontal cortex (DLPFC). 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. Score of generalized anxiety from GAD-Q-IV questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: GAD-Q-IV questionnaire. Score of depression from Beck depression questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Beck depression questionnaire. Score of worry from PSWQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: PSWQ questionnaire. Score of intolerance of uncertainty from IUS. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: IUS questionnaire. Score of cognitive fusion from CFQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CFQ questionnaire. Score of cognitive avoidance from CAQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CAQ questionnaire. Score of difficulties in emotion regulation from DERS. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: DERS questionnare. Score of cognitive emotion regulation from CERQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CERQ questionnaire. Score of emotion regulation from ERQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: ERQ questionnaire. Score of anxiety sensitivity from ASI. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: ASI questionnaire. Score of cognitive flexibility from Wisconsin test. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Wisconsin card sorting test. Score of inhibition from go/no go test. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Go/no go software. Score of working memory from n-back test. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: N- back software. Ferdowsi University of Mashhad Approved 2018-12-26 Ethics Committee in Bioresearch Azadi Square., campus of Ferdowsi university of Mashhad., Central organization Mashhad Razavi Khorasan Iran (Islamic Republic of)