Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Absence of cognitive impairment, no reported alcohol or drug abuse, no simultaneous participation in other psychological treatment courses, and no current psychiatric medication usage.
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Intervention groups
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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.
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Main outcome variables
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Psychological Symptoms; Cognitive Functions; Cognitive-Emotional Features
General information
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Reason for update
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At the time of registration, the date was mistakenly recorded as 2024 instead of 2023.
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Acronym
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EMDR, GAD
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IRCT registration information
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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
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Registration date
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2024-07-23, 1403/05/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-20, 1402/06/29
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Expected recruitment end date
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2023-10-20, 1402/07/28
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Actual recruitment start date
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2023-09-20, 1402/06/29
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Actual recruitment end date
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2023-10-20, 1402/07/28
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Trial completion date
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2024-06-19, 1403/03/30
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Scientific title
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The Comparison of Face-to-face and Web-based EMDR Efficacy on Psychological Symptoms, Cognitive Functions and Cognitive-Emotional Features in Generalized Anxiety Disorder
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Public title
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The Comparison of Face-to-face and Web-based EMDR Efficacy in Generalized Anxiety Disorder
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
69
Actual sample size reached:
69
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-18, 1402/03/28
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Ethics committee reference number
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IR.BPUMS.REC.1402.070
Health conditions studied
1
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Description of health condition studied
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Generalized Anxiety Disorder
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
Primary outcomes
1
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Description
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Psychological Symptoms
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Timepoint
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Before the intervention, after the last intervention session, one and three months after the last intervention session
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Method of measurement
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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
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Description
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Cognitive function
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Timepoint
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Before the intervention, after the last intervention session, one and three months after the last intervention session
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Method of measurement
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Wisconsin card sorting test (WCST), Tower of Hanoi (ToH), N-Back
2
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Description
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Cognitive emotional feature
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Timepoint
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Before the intervention, after the last intervention session, one and three months after the last intervention session
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Method of measurement
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Cognitive Emotion Regulation Questionnaire-Short (CERQ-Short), Semantic Stroop Test
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
3
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Persian Gulf University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The access period starts 6 months after the results are published.
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To whom data/document is available
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The data of this study will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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The data of this study will be provided for use by researchers in review or comparative studies.
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From where data/document is obtainable
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Fatemeh Jamshidi, Department of Psychology, Persian Gulf University, Bushehr, Iran. fateme_jamshidi7@yahoo.com 0098120297756
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What processes are involved for a request to access data/document
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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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Comments
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