- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06054386
Attention Bias Modification Training for Social Phobia (ABMSP)
Mobile-based Attentional Bias Modification Training (ABMT) for Socially Anxious Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals with at least mild level of social anxiety symptoms will be invited to the current study. Participants will be randomly assigned to one of the two attention training conditions: a Integrated Attentional Bias Modification (I-ABM) training or placebo training (PLT). Before and after the training, participants will complete computerized tasks (e.g., attention network task, dot-probe task) and self-report questionnaires.
The basic design of I-ABM training will follow the dot-probe task, which will ask participants to swipe or tap on the probe in the correct direction. The I-ABM training aims to shift attention away from threatening stimuli or improve the inhibitory control ability. The PLT training will have the same basic design, but this will not include therapeutic components. Participants will complete the training three times per week for three weeks (a total of 9 training sessions), and there will be post-training and a 2-week follow-up assessment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yourim Kim, M.A.
- Phone Number: 414-251-5124
- Email: yourim@uwm.edu
Study Contact Backup
- Name: Han-Joo Lee, PhD
- Phone Number: 414-229-5858
- Email: leehj@uwm.edu
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- Recruiting
- University of Wisconsin-Milwaukee
-
Contact:
- Yourim Kim, M.A.
- Phone Number: 414-251-5124
- Email: yourim@uwm.edu
-
Contact:
- Han-Joo Lee, PhD
- Phone Number: 414-229-5858
- Email: leehj@uwm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of social anxiety disorder (based on the DIAMOND interview - Social anxiety module)
- Moderate or severe symptoms of social anxiety as revealed by the Liebowitz Social Anxiety Scale (LSAS score of ≥ 40) or MINI-SPIN (Score of ≥ 6)
- Ages 18-60
- English as a primary language
- Possession of a mobile device for access to the app (Inquisit 6)
Exclusion Criteria:
- Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
- Self-reported history of a bipolar disorder or psychotic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Integrated ABM (I-ABM)
The I-ABM will include four progressively difficult levels of training blocks, each containing 72 trials.
Participants will be required to tap or swipe the probe in the correct direction during the first and second levels of training.
The inhibitory control components will be included in the third and fourth levels, where participants should not respond to the probe under certain conditions.
Each training will take 10-15 minutes, and participants will complete the sessions three times a week for three weeks.
|
The ABMT is aimed to modify attentional bias for negative stimuli in social anxiety by deliberately inducing the participant's attention to positive or neutral stimuli.
In the training, after a pair of facial stimuli (e.g., threatening-neutral, neutral-neutral) are presented, a left or right arrow appears in one of the location.
Participants are instructed to press the button in the correct direction as quickly and accurately as possible.
|
Placebo Comparator: Placebo Training (PLT)
The PLT has four training blocks that follow the same basic design as the I-ABM training.
However, the PLT will not aim to change social anxiety-related attention bias.
Participants will simply swipe or tap the probe regardless of the stimuli condition, which is expected to exert a minimum level of effect on changing the attention bias linked to social anxiety.
Participants will complete the training three times per week for three weeks.
|
The general attention control training aimed to improve participants' general attention control ability by asking them to press a left or right arrow in the correct direction.
The basic design of attention control training is the same as the ABMT, but the attention control training does not aim to alter the direction of attention toward or away from certain stimuli.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mini-Social Phobia Inventory (Mini-SPIN) across Pre-training, Post-training, and 2-week follow up
Time Frame: Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
|
The Mini-Social Phobia Inventory (Mini-SPIN; Connor et al., 2001) is a 3-item measure which assesses the degree to which an individual experiences fear or avoidance in social situations.
The measure uses a 5-point-Likert rating scale ranges from 0="not at all" to 4="extremely", with a total score range of 0-12.
At a cutoff score of 6, the Mini-SPIN showed sensitivity of 89% and specificity of 90% for detecting generalized social anxiety disorder (Connor et al., 2001).
The higher the scores, the more severe the symptoms of social anxiety.
|
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression, Anxiety, and Stress Scale (DASS-21) across Pre-training, Post-training, and 2-week follow-up
Time Frame: Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
|
The Depression, Anxiety, and Stress scale (DASS-21; Lovibond & Lovibond, 1995) comprises 21 items with three subscales (depression, anxiety, and stress), each subscale consisting of seven items.
Items are rated on a 4-point scale ranging from 0="did not apply to me at all" to 3="applied to me very much or most of the time".
Total scores in each subscale are calculated by adding the scores from seven items and multiplying by two, with each subscale having a total score range of 0-42.
The DASS-21 showed good internal reliability (coefficient alpha ranged between 0.74 and 0.93).
The higher the scores, the more severe the depression, anxiety, and stress symptoms.
|
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
|
Change in Liebowitz Social Anxiety Scale (LSAS-SR) across Pre-training, Post-training, and 2-week follow-up
Time Frame: Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
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The Liebowitz Social Anxiety Scale-Self Report (LSAS-SR; Liebowitz, 1987) assesses the severity of social anxiety and its associated avoidance across a variety of life domains.
The LSAS-SR consists of 24 items that are rated on a 5-point scale from 0 ("none") to 4 ("very severe").
The LSAS-SR is divided into two subscales: fear and avoidance, with total scores ranging from 0-72 for each.
The The higher the scores, the more severe the symptoms of social anxiety.
|
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Han-Joo Lee, PhD, 414-229-5858
Publications and helpful links
General Publications
- Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Heeren A, Mogoase C, Philippot P, McNally RJ. Attention bias modification for social anxiety: A systematic review and meta-analysis. Clin Psychol Rev. 2015 Aug;40:76-90. doi: 10.1016/j.cpr.2015.06.001. Epub 2015 Jun 6.
- Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.
- Amir N, Bomyea J, Beard C. The effect of single-session interpretation modification on attention bias in socially anxious individuals. J Anxiety Disord. 2010 Mar;24(2):178-82. doi: 10.1016/j.janxdis.2009.10.005. Epub 2009 Oct 27.
- Mogg K, Bradley BP. Selective orienting of attention to masked threat faces in social anxiety. Behav Res Ther. 2002 Dec;40(12):1403-14. doi: 10.1016/s0005-7967(02)00017-7.
- Schofield CA, Johnson AL, Inhoff AW, Coles ME. Social anxiety and difficulty disengaging threat: evidence from eye-tracking. Cogn Emot. 2012;26(2):300-11. doi: 10.1080/02699931.2011.602050. Epub 2011 Oct 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWM 21.197
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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