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Protocol summary

Study aim
Determine the effectiveness of face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy for individuals with Generalized Anxiety Disorder (GAD) in comparison with web-based EMDR therapy and a waitlist control condition using a randomized controlled design.
Design
A clinical trial with a control group, parallel groups, not blinded, randomized, phase 2 on 69 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
Following the randomization and allocation of patients in the study groups, the patients in the intervention groups are treated almost twice a week using face-to-face or web-based EMDR therapy. This study will be carried out in the Persian Gulf University psychology department. Due to the nature of the treatments used in this study, there is no possibility of blinding the researcher and the patients.
Participants/Inclusion and exclusion criteria
Absence of cognitive impairment, no reported alcohol or drug abuse, no simultaneous participation in other psychological treatment courses, and no current psychiatric medication usage.
Intervention groups
Intervention group 1: Patients in face-to-face EMDR therapy will receive ten sessions twice weekly, each lasting 90 minutes according to Shapiro’s phobia protocol (2018). Intervention group 2: Patients in web-based EMDR therapy will receive ten sessions twice weekly, each lasting 90 minutes according to Shapiro’s phobia protocol (2018). Control group: The control group will not receive any treatment during the study. However, for ethical reasons, the participants in this group will introduced to the university clinic for treatment.
Main outcome variables
Psychological Symptoms; Cognitive Functions; Cognitive-Emotional Features

General information

Reason for update
At the time of registration, the date was mistakenly recorded as 2024 instead of 2023.
Acronym
EMDR, GAD
IRCT registration information
IRCT registration number: IRCT20240716062442N1
Registration date: 2024-07-23, 1403/05/02
Registration timing: retrospective

Last update: 2025-04-17, 1404/01/28
Update count: 1
Registration date
2024-07-23, 1403/05/02
Registrant information
Name
Fatemeh Jamshidi
Name of organization / entity
Persian gulf university
Country
Iran (Islamic Republic of)
Phone
+98 77 3122 2044
Email address
fateme_jamshidi7@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-20, 1402/06/29
Expected recruitment end date
2023-10-20, 1402/07/28
Actual recruitment start date
2023-09-20, 1402/06/29
Actual recruitment end date
2023-10-20, 1402/07/28
Trial completion date
2024-06-19, 1403/03/30
Scientific title
The Comparison of Face-to-face and Web-based EMDR Efficacy on Psychological Symptoms, Cognitive Functions and Cognitive-Emotional Features in Generalized Anxiety Disorder
Public title
The Comparison of Face-to-face and Web-based EMDR Efficacy in Generalized Anxiety Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of cognitive impairment No used alcohol or drug abuse No simultaneous participation in other psychological treatment courses No reported current psychiatric medication usage
Exclusion criteria:
A lack of motivation to continue treatment sessions
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 69
Actual sample size reached: 69
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committees of Bushehr Province University of Medical Sciences
Street address
Bushehr University of Medical Sciences ,Moalem St., Bushehr.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.BPUMS.REC.1402.070

Health conditions studied

1

Description of health condition studied
Generalized Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Psychological Symptoms
Timepoint
Before the intervention, after the last intervention session, one and three months after the last intervention session
Method of measurement
Generalized Anxiety Disorder 7-Item (GAD-7) Scale, Penn State Worry Questionnaire (PSWQ), The State-Trait Anxiety Inventory—Trait (STAI-T), Beck Anxiety Inventory (BAI), Daily Diary

Secondary outcomes

1

Description
Cognitive function
Timepoint
Before the intervention, after the last intervention session, one and three months after the last intervention session
Method of measurement
Wisconsin card sorting test (WCST), Tower of Hanoi (ToH), N-Back

2

Description
Cognitive emotional feature
Timepoint
Before the intervention, after the last intervention session, one and three months after the last intervention session
Method of measurement
Cognitive Emotion Regulation Questionnaire-Short (CERQ-Short), Semantic Stroop Test

Intervention groups

1

Description
First intervention group: Face-to-face EMDR Therapy: Patients will receive face-to-face EMDR therapy twice a week for ten sessions, each lasting 90 minutes. it will be delivered according to Shapiro’s phobia protocol (2018), consisting of eight phases: Phase One: History taking: The client's history and planning of the treatment will be taken. Phase Two; Preparation: The clinician then will introduce the participants to EMDR procedures, explain the EMDR theory, establish expectations about treatment effects, and prepare the client for possible between-session disturbances. Phase Three; Assessment: The clinicians will determine the targets and baseline measures using the SUD and VOC scales. Phase Four: Desensitization: the clinician will address the client's disturbing emotions and elicit insights and appropriate associations. Phase Five; Installation: after which the treatment focuses on enhancing the integration of cognitive reorganization. Phase Six; Body Scan: residual sensations will be addressed. Phase Seven; Closure: Next, a debriefing phase will be delivered to maintain client equilibrium between sessions. Phase Eight; Re-evaluation: eventually, re-evaluation will be performed.
Category
Behavior

2

Description
Second intervention group: Web-based EMDR Therapy: Patients will receive face-to-face EMDR therapy twice a week for ten sessions, each lasting 90 minutes. it will be delivered according to Shapiro’s phobia protocol (2018), consisting of eight phases: Phase One: History taking: The client's history and planning of the treatment will be taken. Phase Two; Preparation: The clinician then will introduce the participants to EMDR procedures, explain the EMDR theory, establish expectations about treatment effects, and prepare the client for possible between-session disturbances. Phase Three; Assessment: The clinicians will determine the targets and baseline measures using the SUD and VOC scales. Phase Four: Desensitization: the clinician will address the client's disturbing emotions and elicit insights and appropriate associations. Phase Five; Installation: after which the treatment focuses on enhancing the integration of cognitive reorganization. Phase Six; Body Scan: residual sensations will be addressed. Phase Seven; Closure: Next, a debriefing phase will be delivered to maintain client equilibrium between sessions. Phase Eight; Re-evaluation: eventually, re-evaluation will be performed.
Category
Behavior

3

Description
Third intervention group: The control group will not receive any treatment during the study. However, for ethical reasons, the participants in this group will be introduced to the university clinic for treatment.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Persian Gulf University Counseling Center
Full name of responsible person
Fatemeh Jamshidi
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3122 2078
Email
fateme_jamshidi7@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Persian Gulf University
Full name of responsible person
Mohammadreza Golbaharhaghighi
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2078
Email
golbahar@pgu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Persian Gulf University
Proportion provided by this source
100
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
Persian gulf university
Full name of responsible person
Fatemeh Jamshidi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2044
Fax
Email
fateme_jamshidi7@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Fatemeh Jamshidi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2710
Email
fateme_jamshidi7@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Persian gulf university
Full name of responsible person
Fatemeh Jamshidi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2044
Fax
Email
fateme_jamshidi7@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data obtained from the participant's answers to the questionnaires used in the pre-test, post-test, and follow-up period will be analyzed using SPSS software, and the results will be shared as the results of the study, without mentioning the names of the individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data of this study will be provided for use by researchers in review or comparative studies.
From where data/document is obtainable
Fatemeh Jamshidi, Department of Psychology, Persian Gulf University, Bushehr, Iran. fateme_jamshidi7@yahoo.com 0098120297756
What processes are involved for a request to access data/document
The applicant provides information about their application via email. If accepted, documents or data files will be sent up to two weeks after the request.
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