Clinical trials of Eye Movement Desensitization and Reprocessing (EMDR) and Exposure / Response Prevention (ERP) in reducing the anxiety and severity of symptoms in patients with obsessive-compulsive disorder with life stressful experiences.
Determine the effectiveness of EMDR and ERP combination protocols in reducing anxiety and severity of OCD with or without traumatic experience.
Design
Randomized controlled trial. Study population: patients with obsessive-compulsive disorder who referred to by psychiatrist for psychotherapy with OCD diagnosis. The target sample was screened using vital life events questionnaire and structured interview based on DSM-5 and positive OCD diagnosis and life traumatic experiences before the onset of the disease, based on the criteria for include and exclude the study in each of the two intervention groups Based on the Cohen formula, 25 people and considering the probability of falling in each group, 30 were randomly selected and assigned to two intervention groups.
Settings and conduct
The drop in patients with ERP is about 40 to 52 percent. Case studies have shown that the combination of Eye Movement Sensitivity (EMDR) with exposure and response avoidance (ERP) increases the percentage of recovery. In this clinical trial, OCD patients who referred for psychiatry to the psychiatric ward of 22 Bahman Qazvin Psychiatric Hospital were randomly assigned to 13 treatment sessions with one of the two EMDR + ERP protocols and the protocol ERP standard. Both groups are evaluated before, after and after three months after the end of treatment sessions with Beck Anxiety Inventory(BAI) and Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Participants/Inclusion and exclusion criteria
Patients with resistance to medical treatment with obsessive-compulsive disorder with a history of effective life stressful experience.
Intervention groups
1-Combined Group of Eye Movements and Reprocessing / Exposure and Response Prevention.
2- Exposure and Response Prevention
Main outcome variables
Assessment of anxiety; severity of OCD symptoms; Reliable Change Index (RCI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190319043090N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
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
Clinical trials of Eye Movement Desensitization and Reprocessing (EMDR) and Exposure / Response Prevention (ERP) in reducing the anxiety and severity of symptoms in patients with obsessive-compulsive disorder with life stressful experiences.
Public title
Comparison of the effectiveness of ERP and its combination with EMDR in the treatment of OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The primary diagnosis of OCD is according to the DSM-5 criteria, which will be determined by the clinical-structured clinical interview of SCID-I by clinical psychologists and experienced psychiatrists who have been trained in OCD evaluation.
Score Y-BOCS ≥16
If there is depression, the secondary is OCD
Age range 18 to 60 years
Patients will receive a standard dose of SSRIs throughout the course of treatment under the supervision of a psychiatrist
Minimum IQ of 80 / or minimum education in secondary school 2 / or equivalent.
Declaration of satisfaction regarding participation in the research project (complete written consent).
Exclusion criteria:
The presence of comorbidities in either now or in the past other than depression.
Drug abuse
Enemy suicide attempt
Psychiatric disorders due to medical conditions
Personality disorders
Receive simultaneously any psychological treatment currently for axis I disorders
Dissatisfaction with the continuation and completion of the treatment process at each stage of the research
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 randomization with respect to alignment
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
Department of Clinical Psychology, University of Social Welfare and Rehabilitation Sciences, Tehran, 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
F40-F48 Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Severity of symptoms of obsessive- compulsive disorder
Timepoint
Pre-test pre-intervention-post-test after the completion of 13 sessions of therapy and follow up 3 months after the post-test stage
Method of measurement
Yale‐Brown obsessive–compulsive scale (YBOCS)
Secondary outcomes
1
Description
Anxiety
Timepoint
Pre-test pre-intervention-post-test after the completion of 13 sessions of therapy and follow up 3 months after the post-test stage
Method of measurement
Beck Anxiety Inventori
Intervention groups
1
Description
Intervention group: Experimental group with pre / post test and follow-up :Intervention group 1: 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 13 treatment sessions of 75 to 90 minutes.Assessments will be conducted in three stages: pre-test, post-test and follow-up of 3 months.
Category
Treatment - Other
2
Description
Control group: Implementation of the Exposure / Response Prevention Protocol (ERP) alone as the standard treatment for OCD in a group of 30 randomly selected patients with OCD with experience of life-threatening and resistant drug therapy in 13 treatment sessions of 75 to 90minutes.Assessments will be conducted in three stages: pre-test, post-test and follow-up of 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin 22 Bahman Psychiatric Hospital
Full name of responsible person
Dr.sayed Alireza Hajisayedjavdi
Street address
Rah Ahan
City
Qazvin
Province
Qazvin
Postal code
3416899198
Phone
+98 28 3335 5554
Fax
+98 28 3335 5554
Email
mesarichloo@yahoo.com
Web page address
http://hos22bahman.qums.ac.ir/Portal/Home/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
mohammad- reza khodaie -ardakani
Street address
University of SocialWelfare & Rehabilitation Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 3340 1604
Email
Kh.ardakani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research support
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Ebrahim Sarichloo
Position
Ph.D candidate of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
22 Bahman Hospital- Nursing Alley- Rah ahan Ave.
City
Qazvin
Province
Qazvin
Postal code
1111111111
Phone
+98 28 3355 5054
Email
mesarichloo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farhad Taremian
Position
Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, University of SocialWelfare & Rehabilitation Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0045
Email
taremian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Ebrahim Sarichloo
Position
Ph.D candidate student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, University of SocialWelfare & Rehabilitation Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0045
Email
mesarichloo@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcomes can be shared
When the data will become available and for how long
starting 3 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Use in meta analyzes
From where data/document is obtainable
mesarichloo@yahoo.com
What processes are involved for a request to access data/document
Send by request via e-mail and receive a reply in a month
Comments
Intervention protocols can be sent to university applicants in research fields provided that they are cited in scientific documents.