NCT07562633

Brief Summary

This study examines whether a proactive thought control intervention can reduce negative core beliefs, cognitive biases, and anxiety symptoms in university students with social anxiety. Participants with elevated social anxiety (screened via the Liebowitz Social Anxiety Scale) are randomly assigned to either a proactive thought control group or a reactive control group. Both groups complete two computerized tasks - a Free Association Task and a Sentence Completion Task - across 180 trials. The proactive group is trained to generate only positive or neutral associations to socially threatening cues and receives real-time AI-powered sentiment feedback, while the reactive group responds freely without sentiment-based guidance. Outcomes including negative core beliefs, interpretation bias, attentional bias, state anxiety, and trait anxiety are assessed before and after the intervention using standardized measures (CBQ, WSAP, Dot Probe Task, STAI). The study uses a parallel-group randomized controlled trial design with repeated measures and aims to establish preliminary effect size estimates for future, larger-scale trials.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Keywords

Social Anxiety DisorderRCTProactive Thought ControlAI feedbackCore BeliefsCognitive Biases

Outcome Measures

Primary Outcomes (3)

  • Core Beliefs: Change in Negative Core Beliefs as Measured by the Core Belief Questionnaire (CBQ)

    The Core Belief Questionnaire (CBQ; Wong et al., 2017) measures negative core beliefs in socially anxious individuals across three versions: trait (beliefs about self), contingent (beliefs about self when negatively evaluated), and other (beliefs about others). Each scale contains 17 items rated on a 6-point Likert scale (1 = strongly disbelieve to 6 = strongly believe). Total scores range from 17 to 102, with higher scores indicating stronger negative core beliefs. In this study, the trait and other subscales are used. Change scores from pre- to post-intervention are compared between the proactive thought control group and the reactive control group.

    Baseline (pre-intervention) and immediately after intervention completion (post-intervention)

  • Interpretation Biases: Change in Interpretation Bias as Measured by the Word Sentence Association Paradigm (WSAP)

    The WSAP (Beard \& Amir, 2009) is a computerized task measuring interpretation bias toward threatening versus benign interpretations of ambiguous social scenarios. Each trial presents a word cue followed by an ambiguous sentence; participants judge relatedness by pressing Y or N. Bias is scored as the proportion of trials in which participants endorse threatening word-sentence pairings. Higher proportions indicate stronger negative interpretation bias. The task includes 30 trials with threatening and benign word-sentence pairs presented in randomized, counterbalanced order across pre- and post-assessments.

    Baseline (pre-intervention) and immediately after intervention completion (post-intervention)

  • Attentional Biases: Change in Attentional Bias as Measured by the Dot Probe Task

    The Dot Probe Task (MacLeod et al., 1986) measures attentional bias toward threatening stimuli using reaction times. Each trial presents a threatening and a neutral word simultaneously; a probe then replaces one stimulus. The Attentional Bias Index (ABI) is calculated as: mean RT on threat-incongruent trials minus mean RT on threat-congruent trials. Positive ABI scores indicate vigilance toward threat; negative scores indicate avoidance; scores near zero indicate no bias. Trials with RTs below 200 ms or above 1500 ms and incorrect responses are excluded. The task includes 30 trials in counterbalanced, randomized order across assessments.

    Baseline (pre-intervention) and immediately after intervention completion (post-intervention)

Secondary Outcomes (1)

  • State Trait Anxiety:Change in State-Trait Anxiety as Measured by the STAI - Short Form (STAI-State Subscale)

    Baseline (pre-intervention) and immediately after intervention completion (post-intervention)

Other Outcomes (1)

  • Baseline Depression, Anxiety, and Stress Levels as Measured by the DASS-12

    Screening only

Study Arms (2)

Proactive Thought Control

EXPERIMENTAL

Participants in this arm completed a modified Free Association Task (FAT) and Sentence Completion Task (SCT) across 180 trials (6 blocks of 30). They were instructed to generate only positive or neutral single-word responses to socially threatening cues and could not advance within a trial until doing so. Real-time AI-powered sentiment feedback (DistilBERT) reinforced positive/neutral responses with "+2 Score" and corrective guidance for negative responses. A gamified points system sustained engagement. Pre- and post-assessments included the CBQ, STAI, WSAP, and Dot Probe Task.

Behavioral: Proactive Thought Conrol

Reactive Thought Control

ACTIVE COMPARATOR

Participants in this arm completed the same Free Association Task (FAT) and Sentence Completion Task (SCT) across 180 trials (6 blocks of 30) as the experimental group, but responded freely without any restriction on response valence. They received only neutral quality-based feedback (e.g., for repeated, misspelled, or invalid entries) with no sentiment-based reinforcement or corrective guidance. This active sham condition controlled for task engagement, the Hawthorne effect, and demand characteristics. Pre- and post-assessments were identical to those of the experimental arm.

Behavioral: Reactive Thought Control

Interventions

A computerized behavioral intervention delivered across 180 trials in six blocks. The first three blocks use a Free Association Task (FAT), where participants respond to single threatening or neutral word cues. The last three blocks use a Sentence Completion Task (SCT), where participants complete socially threatening or neutral sentence stems. Participants in the proactive group must generate positive or neutral single-word responses and cannot advance until doing so. Real-time sentiment feedback is delivered via DistilBERT (an AI language model), awarding +2 points for positive/neutral responses and providing corrective guidance for negative ones. The reactive control group completes identical tasks but responds freely, receiving only neutral quality-based feedback without sentiment reinforcement. Both groups receive feedback for repeated, misspelled, or invalid entries. Each block contains 25 threatening and 5 positive/neutral stimuli presented in randomized order.

Proactive Thought Control

A computerized behavioral sham condition delivered across 180 trials in six blocks, identical in structure to the experimental intervention. The first three blocks use a Free Association Task (FAT) and the last three use a Sentence Completion Task (SCT), both involving socially threatening and neutral stimuli. Participants respond freely with any single-word association without restriction on response valence. No sentiment-based feedback or scoring is provided. Participants receive only neutral quality-based feedback for repeated, misspelled, or invalid entries. This condition controls for nonspecific factors including task engagement, time-on-task, the Hawthorne effect, and demand characteristics, while isolating the active ingredient of proactive sentiment-directed training present in the experimental arm.

Reactive Thought Control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • being 18-24 years old
  • not taking any additional psychological treatments during the trial
  • If taking medication for depression or anxiety, the dosage had to remain consistent for one month before the start of therapy.
  • Cut off score above 30 in LSAS
  • Consent to participate in the study and complete all tasks.
  • Proficiency in English

You may not qualify if:

  • Age below 18 or above 24 years
  • Currently receiving psychological treatment
  • Failure to provide consent or complete the study tasks
  • Have any other medical condition
  • Have any other psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GIFT University

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (6)

  • Wong QJJ, Gregory B, Gaston JE, Rapee RM, Wilson JK, Abbott MJ. Development and validation of the Core Beliefs Questionnaire in a sample of individuals with social anxiety disorder. J Affect Disord. 2017 Jan 1;207:121-127. doi: 10.1016/j.jad.2016.09.020. Epub 2016 Sep 23.

  • Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.

  • MacLeod C, Mathews A, Tata P. Attentional bias in emotional disorders. J Abnorm Psychol. 1986 Feb;95(1):15-20. doi: 10.1037//0021-843x.95.1.15. No abstract available.

  • 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.

  • Braver TS. The variable nature of cognitive control: a dual mechanisms framework. Trends Cogn Sci. 2012 Feb;16(2):106-13. doi: 10.1016/j.tics.2011.12.010. Epub 2012 Jan 12.

  • Amir N, Beard C, Burns M, Bomyea J. Attention modification program in individuals with generalized anxiety disorder. J Abnorm Psychol. 2009 Feb;118(1):28-33. doi: 10.1037/a0012589.

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

April 20, 2025

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Plan Description: De-identified individual participant data (IPD) underlying the primary and secondary outcome analyses will be shared, including pre- and post-intervention scores on the Core Belief Questionnaire (CBQ), Word Sentence Association Paradigm (WSAP), Dot Probe Task, and State-Trait Anxiety Inventory (STAI). Raw reaction time data from the WSAP and Dot Probe Task, demographic data, and group assignment variables will also be made available. Data will be de-identified in accordance with standard anonymization procedures to protect participant confidentiality. Screening data (SCID, LSAS-SR and DASS-12) will be shared at aggregate level only.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
IPD and supporting information will be available beginning 6 months after publication of primary study findings and will remain accessible for a minimum of 5 years following initial data sharing.
Access Criteria
De-identified IPD will be available to qualified academic researchers for non-commercial research purposes. Requestors must submit a brief research proposal describing the intended use of the data, confirm compliance with applicable ethical and data protection regulations, and sign a data use agreement. Requests will be reviewed by the principal investigator. Data will be shared via a secure file transfer or repository link upon approval.

Locations