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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab Province
      • Dhok Gujra, Punjab Province, Pakistan, 51700
        • University of Gujrat
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: WSAP-based 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.
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.
Behavioral: WSAP 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ather Mujitaba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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