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IRCT20191230045947N1 IRCT 2020-07-19 University of social welfare and rehabilitation sciences TARGET Efficacy The Efficacy of TARGET Model in Reducing Anxiety Symptoms and Correlates of Trauma among Women with Anxiety Disorders who had histories of Childhood Trauma 2020-08-22 anticipated 40 Complete https://irct.ir/trial/44619 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. After the initial screening, 40 people who meet the inclusion criteria and gave informed consent to participate in the study are selected. The Online randomization method is used to create randomization sequences. The randomization unit is an individual, and the GraphpaPad website is the randomization tool. In order to allocation concealment, central randomization method is used. That is, the randomization sequence is provided to the Kolahdooz center, and the researcher, based on the order in which the participants enter the study, communicates with the relevant center and, in the case of the random allocation of the participant, is assigned to the participant. Communication methods include the use of phone or text messages. N/A Condition 1: Anxiety Disorders. Condition 2: Childhood Trauma. Intervention 1: Intervention group: TARGET Group Therapy. TARGET (Trauma Affect Regulation: Guide for Education and Therapy) is one of the new methods of cognitive-behavioral therapy, useful for traumatic disorders. This method trains emotional self-regulation skills for survivors of trauma. This program includes 7 skills, called 7 steps towards FREEDOM, and each of the FREEDOM letters is representative of one skill. According to the group's Manual, the patients participate in 10 sessions (90-minute each session) of emotional self-regulation skills and stress management. These sessions hold once per week. Intervention 2: Control group: Psychiatric medications. Patients with anxiety disorders who visit a psychiatrist receive their medications depending on the type and severity of the disorder. The most common prescriptions for these patients are Citalopram 20, once per night; Chlorodiazepoxide 10, once per night; S Citalopram 10, once per night; Clonazepam 1, once per night; Gabapentin 100 capsules, consuming in the morning, noon, and at night. The duration of usage, depending on the severity of the disorder and after the control of symptoms, lasts for six months to one year in for stabilization. No - There is not a plan to make this available Justification or reason for not sharing IPD is The sensitivity of trauma and confidentiality of patients' information
public Narges Barzgar
Clinical psychology department, University of social welfare and rehabilitation sciences, koodakyar, daneshjoo blvd, evin, Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0045 Narkises73@gmail.com University of social welfare and rehabilitation sciences scientific Narges Barzgar
Clinical psychology department, University of social welfare and rehabilitation sciences, koodakyar, daneshjoo blvd, evin, Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0045 Narkises73@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Iran (Islamic Republic of) History of childhood trauma suffering from an anxiety disorder Severity of anxiety ranging from 20 to 53 in Spielberger Anxiey Questionnaire Informed Consent Female gender ages 18 to 65 18 years 65 years Female Having severe mental disorders including Schizophrenia spectrum and Bipolar; Antisocial, Borderline, Paranoid, and Schizotypal Personality Disorders Having severe personality disorders including antisocial, borderline, paranoid, and schizotypal personality disorders Evidence of cognitive impairments (orientation, attention, and impaired memory in Mini–mental state examination- MMSE) Hospitalization in a psychiatric hospital in the last month Participate in another psychological treatment at the same time F40 F93.9 Phobic anxiety disorders Childhood emotional disorder, unspecified Treatment - Other Treatment - Drugs Intervention group: TARGET Group Therapy. TARGET (Trauma Affect Regulation: Guide for Education and Therapy) is one of the new methods of cognitive-behavioral therapy, useful for traumatic disorders. This method trains emotional self-regulation skills for survivors of trauma. This program includes 7 skills, called 7 steps towards FREEDOM, and each of the FREEDOM letters is representative of one skill. According to the group's Manual, the patients participate in 10 sessions (90-minute each session) of emotional self-regulation skills and stress management. These sessions hold once per week. Control group: Psychiatric medications. Patients with anxiety disorders who visit a psychiatrist receive their medications depending on the type and severity of the disorder. The most common prescriptions for these patients are Citalopram 20, once per night; Chlorodiazepoxide 10, once per night; S Citalopram 10, once per night; Clonazepam 1, once per night; Gabapentin 100 capsules, consuming in the morning, noon, and at night. The duration of usage, depending on the severity of the disorder and after the control of symptoms, lasts for six months to one year in for stabilization. Anxiety level based of Spiel Berger's Inventory (STAI). Timepoint: Before the intervention, 2 weeks after the intervention, 2 months later in the follow-up. Method of measurement: Spiel Berger's Anxiety Questionnaire (STAI). Depression score. Timepoint: Before the intervention, 2 weeks after the intervention, and 2-month follow-up. Method of measurement: Beck Depression Inventory-II (BDI-II). Posttraumatic Cognitions. Timepoint: Before the intervention, 2 weeks after the intervention, and 2-month follow-up. Method of measurement: Posttraumatic Cognitions Inventory- 9 item (PTCI-9). Coping Strategies. Timepoint: Before the intervention, 2 weeks after the intervention, and 2-month follow-up. Method of measurement: COPE-brief. Emotion Dysregulation. Timepoint: Before the intervention, 2 weeks after the intervention, and 2-month follow-up. Method of measurement: ِDifficulties in Emotion Regulation Scale (DERS-16). University of social welfare and rehabilitation sciences Approved 2020-02-25 Ethics committee of University of Social Welfare and Rehabilitation Sciences kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)