Protocol summary

Study aim
to investigate the effect of a computer intervention on reducing attention bias to negative social stimuli
Design
Clinical trial with control group, with parallel groups, double-blind, randomized using Sealed Envelope Ltd Online Randomization Service. 2019, 60 patients.
Settings and conduct
1. Coding of computer tasks and designing website. 2. Allocation of patients in Guilan University to one of two study groups using block randomization. The participants and the assistant evaluating the outcome variables will be unaware of the group type. The location of study is the counseling center of Guilan University. 3. Measurement of outcome variables at pre- and post-assessment, and two-month follow-up and participation in 8 online sessions of Attention Bias Modification Program
Participants/Inclusion and exclusion criteria
Inclusion: having social anxiety score above 30 in LSAS. Exclusion: having any severe mental and/or organic disorders affecting on the research, and receiving psychological treatment in last 6 months or medication in last 3 months
Intervention groups
A computer intervention called Attention Bias Modification Program, which is designed to reduce attention bias to negative stimuli, will be implemented on students with clinical social anxiety. In this program, two neutral and anger facial images are repeatedly displayed on the computer screen, and the participant must quickly and accurately identify type of probe (> or <) that appear in location of neutral face. The only difference between control group and the intervention group is that because in its computer program, instead of two negative and neutral faces, only one neutral face is used, so the participant does not pay attention to the neutral in the presence of the negative stimulus.
Main outcome variables
Social anxiety and attention bias to negative stimuli

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210613051562N1
Registration date: 2022-10-04, 1401/07/12
Registration timing: prospective

Last update: 2022-10-04, 1401/07/12
Update count: 0
Registration date
2022-10-04, 1401/07/12
Registrant information
Name
Hassan Farrahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
h.farrahi14@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of an Internet-based attention modification intervention on reducing social anxiety in student with social anxiety disorder: a clinical trial
Public title
The efficacy of an Internet-based intervention on reducing social anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to read fluently in Persian Access to a computer and internet connection Having social anxiety higher than 30 on the Liebowitz Social Anxiety Scale
Exclusion criteria:
Having current or previous schizophrenia, schizoaffective, or bipolar disorders Having diseases that would negatively affect participation in the current study, such as epilepsy or brain damage History of stroke or neurodegenerative diseases Substance abuse and dependence in the last 6 months Current cognitive impairment Suicidal intention in the last 3 months Visual impairment affecting participation in research Receiving psychological treatment currently or in the past 6 months Receiving medication-based treatment leading to recovery now or in the last 3 months
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible people will be divided into intervention and control groups using the block randomization method with the size of blocks of 4 and 6. To generate randomization list, online randomization service of Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v(۱/lists). Concealment is done through sealed opaque envelopes in a random sequence. Preparing these envelopes and determining the sequence of random allocation is done by a researcher who has no knowledge or connection with the participants. In the first in-person meeting with each participant, the researcher, who did not participate in determining the sequence of random allocation and does not know the type of participant's group, provides the participant with the previously prepared envelope. In this way, the researcher evaluating the outcome variables as well as the participants will be unaware of the group type.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be unaware of their group type. Also, a researcher who divides the participants into two study groups, implements the measurement tools before starting the treatment (pre-test) and re-implements the same tools after the treatment is completed (post-test), will not know the type of the participants' group. In the explanation of the research, the participants will be told that "the present study is to be conducted in order to investigate the efficacy of a computer-based treatment for social anxiety and they will be randomly assigned to one of the two study groups, and depending on their group, they will complete one of the two computer-based programs; one of these programs is designed to treat social anxiety, but the other program is not designed to reduce social anxiety and may have a placebo effect."
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
Education unit, Shafa hospital, 15 Khordad street
City
Rasht
Province
Guilan
Postal code
4193955599
Approval date
2022-06-29, 1401/04/08
Ethics committee reference number
IR.GUMS.REC.1401.155

Health conditions studied

1

Description of health condition studied
Social Anxiety Disorder (social phobia)
ICD-10 code
F40.10
ICD-10 code description
Social phobia, unspecified

Primary outcomes

1

Description
attention bias
Timepoint
Before intervention, after intervention, and 2 month after intervention.
Method of measurement
Dot probe task

2

Description
Social anxiety
Timepoint
Before intervention, after intervention, and 2 month after intervention.
Method of measurement
Liebowitz Social Anxiety Scale

Secondary outcomes

1

Description
Trait anxiety
Timepoint
Before intervention, after intervention, and 2 month after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory

2

Description
Depression
Timepoint
Before intervention, after intervention, and 2 month after intervention
Method of measurement
Patient Health Questionnaire-9

Intervention groups

1

Description
Intervention group:The intervention group consists of students diagnosed with social anxiety disorder, and the "Attention Bias Modification Program" will be implemented on them as a therapeutic intervention. To implement the Attention Bias Modification Program intervention, the probe detection task will be used, which is a modified form of the task used to measure attention bias. In this computer intervention, during 160 trials, neutral and negative face images appear equally in random order in the upper and lower parts of the screen, and then the probe mark appears in the place where the neutral image was located. Repeating this procedure enables the participant to realize that the neutral images are predictive of the location of the probe. The rationale behind Attention Bias Modification Program is that, although participants are not told to shift their attention away from the negative and threatening image, the location of the neutral image represents the probe location on all trials, thereby facilitating participants' attention to the non-threatening stimuli.
Category
Treatment - Other

2

Description
Control group:The control group consists of students diagnosed with social anxiety disorder, and the only difference between them and the intervention group is the implementation of an intervention, which according to the research literature is not effective and acts as a placebo. The task of this group (Attention Control Condition) is similar to the task used in the intervention group, except that during the presentation of trials, only one neutral image appear, instead of two negative and neutral images in task of intervention group. Therefore, because negative and neutral facial images are not used simultaneously, participants will not learn to pay attention to neutral in the presence of negative stimuli.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling Center of Guilan University
Full name of responsible person
Mousa Kafie
Street address
Guilan University Complex, 5th Kilometer of Persian Golf Highway
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0448
Email
int@guilan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Counseling Center of Guilan University
Full name of responsible person
Dr. Mousa Kafie, Head of Counseling Center
Street address
Counseling Center, Guilan University Complex, 5th Kilometer of Persian Golf Highway
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0465
Email
mosakafie@yahoo.com
Web page address
https://moshavereh.guilan.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Counseling Center of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Hassan Farrahi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Education unit, Shafa hospital, 15th khordad
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 6268
Email
h.farrahi14@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hassan Farrahi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Education unit, Shafa hospital, street 15th khordad
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 6268
Email
h.farrahi14@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hassan Farrahi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Education unit, Shafa hospital, 15 Khordad street
City
Rasht
Province
Guilan
Postal code
4193955599
Phone
+98 13 3366 6268
Email
hfarrahi@gums.ac.ir

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
At the moment, we have not decided to share the data, however, if there is a request from the researchers, it will be made available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...