- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406321
Brief Interpretation Bias Modification for Social Anxiety Disorder in Pakistani Young Adults: An Experimental Evaluation (BIBM-SAD-PYA)
February 5, 2026 updated by: Ather Mujitaba
Efficacy of Cognitive Bias Modification Itervention in Young Adult With Social Anxiety
This randomized, single-blind trial tests whether one session of interpretation bias modification reduces immediate social-evaluative anxiety and shifts interpretation bias in Pakistani university students aged 18 to 25 years with elevated social anxiety.
Participants are assigned to either feedback-contingent interpretation bias modification or a structurally matched interpretation control condition.
Primary and secondary outcomes are assessed before and after the intervention session using short-form state-trait anxiety measures and Word-Sentence Association Paradigm endorsement indices.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Social anxiety in young adults is maintained in part by a tendency to interpret ambiguous social information as threatening.
The study evaluates a behavioral interpretation training procedure delivered with OpenSesame, using trial-by-trial responses to ambiguous social sentences preceded by threat or benign prime words.
In the experimental arm, feedback contingently reinforces benign endorsements and threat rejections.
In the control arm, exposure and timing are matched but feedback is noncontingent and presented on half of trials.
The design is a parallel two-arm randomized pretest-posttest trial with participant masking to assignment.
Assessment includes the 5-item state and 5-item trait short-form State-Trait Anxiety Inventory totals and Word-Sentence Association Paradigm threat and benign endorsement proportions.
The mechanistic hypothesis is that feedback-consistent learning increases benign interpretations and reduces threat interpretations, which is associated with lower post-session state anxiety.
The trial was conducted as part of a PhD thesis at the University of Gujrat under formal institutional approvals.
Study Type
Interventional
Enrollment (Estimated)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ather mujitaba mujitaba Mujitaba, PhD Scholar
- Phone Number: +923297596056
- Email: ather.mujitaba@gift.edu.pk
Study Locations
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Punjab Province
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Dhok Gujra, Punjab Province, Pakistan, 51700
- University of Gujrat
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Contact:
- Dr Saima Riaz, PhD
- Phone Number: +92 (53) 22600 +(92) 92532260000
- Email: saim.riaz@uog.edu.pk
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 18 to 25 years
- Social Phobia Inventory score greater than 19
- at least moderate severity on the DSM-5-TR Severity Measure for Social Anxiety Disorder-Adult
- able to read study materials
- provides written informed consent.
Exclusion Criteria:
- clinically elevated depressive symptoms on Beck Depression Inventory-II at or above prespecified cutoff [above 16]
- clinically elevated general anxiety symptoms on the Beck Anxiety Inventory at or above prespecified cutoff [ above 20]
- current medical or psychiatric condition likely to interfere with safe or valid participation
- prior participation in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Interpretation Bias Modification
Single-session Word-Sentence Association Paradigm training with performance-contingent feedback across 220 trials in two 110-trial blocks; each block includes 70 social ambiguity trials and 40 non-social fillers.
Correct feedback follows benign endorsement or threat rejection; incorrect feedback follows threat endorsement or benign rejection.
|
Single-session Word-Sentence Association Paradigm training with performance-contingent feedback across 220 trials in two 110-trial blocks; each block includes 70 social ambiguity trials and 40 non-social fillers.
Correct feedback follows benign endorsement or threat rejection; incorrect feedback follows threat endorsement or benign rejection.
|
|
Active Comparator: Interpretation Control Condition
Matched Word-Sentence Association Paradigm exposure with identical stimulus timing and response demands, feedback delivered on 50 percent of trials without contingency, favoring benign over threat interpretations.
|
Matched Word-Sentence Association Paradigm exposure with identical stimulus timing and response demands, feedback delivered on 50 percent of trials without contingency favoring benign over threat interpretations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
short version of the Spielberger State-Trait Anxiety Inventory
Time Frame: Baseline (pre-intervention, same visit) and immediate post-intervention after the single-session training (same visit, approximately 30 to 60 minutes after intervention)
|
The primary outcome is within-participant change in state anxiety measured with the 5-item short-form State-Trait Anxiety Inventory state subscale (STAIS-5).
Items are summed to a total score, with higher scores indicating greater state anxiety.
The primary comparison is the between-group difference in change score (IBM versus ICC).
|
Baseline (pre-intervention, same visit) and immediate post-intervention after the single-session training (same visit, approximately 30 to 60 minutes after intervention)
|
|
Spielberger short-form State-Trait Anxiety Inventory (S-STAI)
Time Frame: Baseline pre-intervention and immediate post-intervention in the same visit (approximately 30 to 60 minutes after training starts).
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Difference between post-session and baseline STAIS-5 total score; higher scores indicate greater state anxiety.
|
Baseline pre-intervention and immediate post-intervention in the same visit (approximately 30 to 60 minutes after training starts).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Word-Sentence Association Paradigm threat endorsement rate.
Time Frame: Baseline pre-intervention and immediate post-intervention in the same visit.
|
Proportion of threat word-sentence pairings endorsed as related; lower values indicate less threat-consistent interpretation.
Used as interpretation bias metrices.
|
Baseline pre-intervention and immediate post-intervention in the same visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saima Riaz Riaz, PhD, University of Gujrat
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 1. Hofmann SG. Cognitive factors that maintain social anxiety disorder: a comprehensive model and its treatment implications. Cogn Behav Ther. 2007;36(4):193-209. doi:10.1080/16506070701421313. 2. Ejaz B, Muazzam A, Anjum A, Pollock G, Nawaz R. Measuring the scale and scope of social anxiety among students in Pakistani higher education institutions: an alternative social anxiety scale. Sustainability. 2020;12(6):2164. doi:10.3390/su12062164. 3. Rapee RM, Heimberg RG. A cognitive-behavioral model of anxiety in social phobia. Behav Res Ther. 1997;35(8):741-756. doi:10.1016/S0005-7967(97)00022-3. 4. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory (Form Y). Palo Alto (CA): Consulting Psychologists Press; 1983. 5. Beard C, Amir N. Negative interpretation bias mediates the effect of social anxiety on state anxiety. Cognit Ther Res. 2010;34(3):292-296. doi:10.1007/s10608-009-9258-6. 6. Hallion LS, Ruscio AM. A meta-analysis of the effect of cognitive bias modification on anxiety and depression. Psychol Bull. 2011;137(6):940-958. doi:10.1037/a0024355. 7. MacLeod C, Mathews A. Cognitive bias modification approaches to anxiety. Annu Rev Clin Psychol. 2012;8:189-217. doi:10.1146/annurev-clinpsy-032511-143052. 8. Amir N, Bomyea J, Beard C. The effect of a single-session interpretation modification on attention bias in socially anxious individuals. J Anxiety Disord. 2010;24(2):178-182. doi:10.1016/j.janxdis.2009.10.005. 9. Beard C, Amir N. Interpretation in social anxiety: when meaning precedes ambiguity. Cognit Ther Res. 2009;33(4):406-415. doi:10.1007/s10608-009-9235-0. 10. Gonsalves M, Whittles RL, Weisberg RB, Beard C. A systematic review of the word sentence association paradigm (WSAP). J Behav Ther Exp Psychiatry. 2019;64:133-148. doi:10.1016/j.jbtep.2019.04.003. 11. Connor KM, Davidson JRT, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). Br J Psychiatry. 200
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
February 5, 2026
First Submitted That Met QC Criteria
February 5, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOG/ORIC/2025/342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data are not available at this stage because the trial is ongoing and data collection is not complete.
After study completion, data cleaning, and primary reporting, the team will determine whether de-identified individual participant data can be shared in line with institutional approvals, participant consent, and applicable regulations.
IPD Sharing Time Frame
Supporting documents will be considered for release after final study completion and primary thesis/manuscript reporting.
The exact release start date and duration have not yet been finalized and will be updated in the registry record after completion.
IPD Sharing Access Criteria
Access procedures are not yet finalized.
Any future sharing will be limited to de-identified materials and will require a reasonable scientific request, ethical use, and institutional approval as applicable.
Final criteria will be added after study completion.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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