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IRCT20190319043090N3 IRCT 2020-01-18 University of social welfare and rehabilitation sciences Effectiveness of Eye Movement Desensitization and Reprocessing(EMDR) plus Exposure / Response Prevention(ERP) in the treatment of OCD symptoms. Effectiveness of Eye Movement Desensitization and Reprocessing(EMDR) plus Exposure / Response Prevention(ERP) in reducing obsessive-compulsive disorder symptoms associated with stressful life experiences: A randomized controlled trial. 2018-02-09 anticipated 60 Complete https://irct.ir/trial/39779 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling is as follows: 1. Patients referred with obsessive-compulsive disorder diagnosis will first receive a structured clinical interview and then will be evaluated using the Traumatic Experiences Questionnaire. 2- In the case of traumatic experiences in life according to the order of referral and considering the study inclusion and exclusion criteria, they will be assigned in one of two intervention groups. 3. Based on random selection, patients whose order of referral is odd will be assigned in the group of eye movements desensitization and reprocessing with exposure / response prevention, and patients whose order of referral is even number in the exposure / response prevention protocol group. N/A Obsessive- Compulsive Disorder. Intervention 1: Intervention group 1: Experimental group with pre / post test and follow-up :Implementation of the Eye Movement Desensitization and Reprocessing in combination with Exposure / Response Prevention protocol in a group of 30 randomly selected patients with OCD with experience of life-saving stress and drug resistance during 12 treatment sessions of 75 to 90 minutes.Assessments will be conducted in three stages: pre-test, post-test and one session for follow-up of 3 months( 13 sessions in total) Description of Eye Movement Desensitization and Reprocessing Protocol with Exposure / Response Protocol: According to Shapiro's adaptive information processing model, EMDR involves the implementation of an eight-step protocol as follows: 1- Getting history and case formulation. 2- Preparation through ensuring that the client has the resources needed to manage the processing of distressing (annoying) information to achieve an adaptive solution. 3- Visual, cognitive, affective, and sensory elements of traumatic memory / memories are identified and the level of distress and the degree of belief in thoughts are measured. 4- The target distressing memory or thought are invoked and simultaneously a series of eye movements are performed (or bilateral auditory and tactile stimulation). This continues until the level of subjective units of disturbance (SUD) and the validity of negative cognition (VOC) reaches zero. A memory is allowed to be processed when it no longer has any emotional or physical discomfort for the client. 5- Transition to a valid positive cognition is reinforced by greater bilateral stimulation. Installation and reinforcement of positive cognition is an essential component of EMDR achieved through a focus on patient’s positive self-assessment and is critical to a positive therapeutic effect. 6- Body [tension] scan: The client can bring to mind a positive thought or memory without any physical tension. 7- Closure or terminating the session after the patient's stress [tension] is reduced and 8- Reevaluation: It includes a reassessment, which is repeated at the beginning of the next session.It was also used intermittently in sessions in combination with the exposure / response prevention protocol. Intervention 2: Intervention group 2: Experimental group with pre / post test and follow-up :Implementation of the Exposure / Response Prevention protocol in a group of 30 randomly selected patients with OCD with experience of life-saving stress and drug resistance during 12 treatment sessions of 75 to 90 minutes.Assessments will be conducted in three stages: pre-test, post-test one session for follow-up of 3 months( 13 sessions in total). During treatment, patients were required to be exposed to stimuli (i.e. situations, thoughts, and senses) that invoke obsessive thoughts or disturbing [intrusive] emotions without obsessive rituals to reduce discomfort (response inhibition). Exposure was initially visualized (imaginary exposure), and after significant reduction in symptoms, the patient was exposed to anxiety revoking stimuli in the form of actual contact (in vivo exposure) and in the form of behavioral exercises. These methods were systematically based on a hierarchy of exposure tasks that became progressively more difficult. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohammad Ebrahim Sarichloo
22 Bahman Hospital- Nursing Alley- Rah ahan Ave.
Qazvin Iran (Islamic Republic of) 3416899198 +98 28 3355 5054 mesarichloo@yahoo.com University of social welfare and rehabilitation sciences scientific Farhad Taremian
Department of Clinical Psychology, University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 2218 0045 taremian@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) The primary diagnosis of Obsessive-Compulsive Disorder (OCD) is according to the Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria, which will be determined by the clinical structured interview (SCID-I) Yale-Brown Obsessive-Compulsive Scale score is equal to or greater than 16 Secondary depression due to obsessive compulsive disorder Age range 18 to 60 years Minimum IQ of 80 / or minimum education in secondary school 2 / or equivalent. Existence of life-threatening or stressful experiences 18 years 60 years Both The presence of comorbidities in either now or in the past other than depression. Substance abuse Intent to commit suicide Psychiatric disorders due to medical conditions Personality disorders Receive simultaneously any psychological treatment currently for axis I disorders Not receiving Selective Serotonin Reuptake Inhibitors(SSRI). F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other Intervention group 1: Experimental group with pre / post test and follow-up :Implementation of the Eye Movement Desensitization and Reprocessing in combination with Exposure / Response Prevention protocol in a group of 30 randomly selected patients with OCD with experience of life-saving stress and drug resistance during 12 treatment sessions of 75 to 90 minutes.Assessments will be conducted in three stages: pre-test, post-test and one session for follow-up of 3 months( 13 sessions in total) Description of Eye Movement Desensitization and Reprocessing Protocol with Exposure / Response Protocol: According to Shapiro's adaptive information processing model, EMDR involves the implementation of an eight-step protocol as follows: 1- Getting history and case formulation. 2- Preparation through ensuring that the client has the resources needed to manage the processing of distressing (annoying) information to achieve an adaptive solution. 3- Visual, cognitive, affective, and sensory elements of traumatic memory / memories are identified and the level of distress and the degree of belief in thoughts are measured. 4- The target distressing memory or thought are invoked and simultaneously a series of eye movements are performed (or bilateral auditory and tactile stimulation). This continues until the level of subjective units of disturbance (SUD) and the validity of negative cognition (VOC) reaches zero. A memory is allowed to be processed when it no longer has any emotional or physical discomfort for the client. 5- Transition to a valid positive cognition is reinforced by greater bilateral stimulation. Installation and reinforcement of positive cognition is an essential component of EMDR achieved through a focus on patient’s positive self-assessment and is critical to a positive therapeutic effect. 6- Body [tension] scan: The client can bring to mind a positive thought or memory without any physical tension. 7- Closure or terminating the session after the patient's stress [tension] is reduced and 8- Reevaluation: It includes a reassessment, which is repeated at the beginning of the next session.It was also used intermittently in sessions in combination with the exposure / response prevention protocol. Intervention group 2: Experimental group with pre / post test and follow-up :Implementation of the Exposure / Response Prevention protocol in a group of 30 randomly selected patients with OCD with experience of life-saving stress and drug resistance during 12 treatment sessions of 75 to 90 minutes.Assessments will be conducted in three stages: pre-test, post-test one session for follow-up of 3 months( 13 sessions in total). During treatment, patients were required to be exposed to stimuli (i.e. situations, thoughts, and senses) that invoke obsessive thoughts or disturbing [intrusive] emotions without obsessive rituals to reduce discomfort (response inhibition). Exposure was initially visualized (imaginary exposure), and after significant reduction in symptoms, the patient was exposed to anxiety revoking stimuli in the form of actual contact (in vivo exposure) and in the form of behavioral exercises. These methods were systematically based on a hierarchy of exposure tasks that became progressively more difficult. Severity of symptoms of obsessive- compulsive disorder. Timepoint: Pre-test pre-intervention, post-test after the completion of 12 sessions of therapy, 1 session for follow up 3 months after the post-test stage(13 sessions in total). Method of measurement: Padua Inventory- Washington State University Revision (PI-WSUR) score. Obsessive-Compulsive type. Timepoint: Pre-test pre-intervention, post-test after the completion of 12 sessions of therapy, follow up 3 months after the post-test stage(13 sessions in total). Method of measurement: Type of obsessive-compulsive disorder according to Padua's Inventory- Washington State University Revision (PI-WSUR). Severity of symptoms of obsessive- compulsive disorder. Timepoint: Post-test after the completion of 12 sessions of therapy and 1 session follow up 3 months after the post-test stage (13 sessions in total). Method of measurement: Padua Inventory- Washington State University Revision (PI-WSUR) score. University of social welfare and rehabilitation sciences Approved 2018-01-21 Ethics Committee of the University of Social Welfare and Rehabilitation Sciences University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., Daneshjo Blvd.,EvinTehran, Iran Tehran Tehran Iran (Islamic Republic of)