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.
Determine the effectiveness of eye movement desensitization and reprocessing plus exposure/ response prevention in reducing symptoms of obsessive-compulsive disorder(OCD).
Design
Two arm parallel group randomized trial with outcome assessment with follow-up after three months. Randomization based on the order of referral of patients in odd and even order.
Settings and conduct
1.Screening for Stressful Experiences of Patients with Obsessive-Compulsive Disorder Referred to Psychotherapy at 22 Bahman Hospital of Qazvin.
2.Randomized assignment of patients in two intervention groups.
3.Pre-test implementation
4. Performing 13 sessions of 75-90 minutes of treatment (including one follow-up session) using the protocol of each intervention.
5. Post-test implementation.
6. Perform follow-up 3 months after the post-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The primary diagnosis of Obsessive-Compulsive Disorder (OCD), 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
Exclusion criteria:
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
Intervention groups
Intervention group 1: Eye movement desensitization and reprocessing plus exposure/ response prevention group: 12 weekly 75-90 minute treatment sessions And a follow-up session after three months (In total 13 sessions);
Intervention group 2: exposure/ response prevention group:12 weekly 75-90 minute treatment sessions and a follow-up session after three months (In total 13 sessions)
Main outcome variables
Type and severity of obsessive-compulsive disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190319043090N3
Registration date:2020-01-18, 1398/10/28
Registration timing:retrospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Mohammad Ebrahim Sarichloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3367 4118
Email address
mesarichloo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-07-16, 1397/04/25
Actual recruitment start date
2018-02-09, 1396/11/20
Actual recruitment end date
2018-07-16, 1397/04/25
Trial completion date
2018-12-21, 1397/09/30
Scientific title
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.
Public title
Effectiveness of Eye Movement Desensitization and Reprocessing(EMDR) plus Exposure / Response Prevention(ERP) in the treatment of OCD symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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).
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., Daneshjo Blvd.,EvinTehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.USWR.REC.1396.301
Health conditions studied
1
Description of health condition studied
Obsessive- Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
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
2
Description
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)
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.