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Social Anxiety DisorderPTC - SANCT07562633

Proactive Thought Control for Social Anxiety Relief

A study testing Proactive Thought Conrol in people with Social Anxiety Disorder, run by GIFT University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 24 years
Conditions the study is for
Social Anxiety Disorder
What is being tested?
Proactive Thought Conrol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 sitePakistan
Study dates
20 Apr 2025to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • Regularly computer user Exclusion Criteria
  • 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
  • Taking medicineInclusion Criteria:

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • GIFT University

    Gujranwala, Punjab Province, 52250

Other trials in Pakistan

About this study

Official title: The Effectiveness of Proactive Thought Control in Modification of Negative Core Beliefs and Cognitive Biases in Individual With Social Anxiety: A Pilot RCT Study

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.

Read the detailed description

Background and Rationale Social anxiety disorder (SAD) is characterized by intense fear of negative evaluation in social situations, leading to significant avoidance and distress. Cognitive models of SAD emphasize the role of negative core beliefs (e.g., beliefs about being inferior or unacceptable to others) and cognitive biases - particularly interpretation bias and attentional bias toward threat - in the maintenance of the disorder. While cognitive bias modification (CBM) approaches have shown promise, most are reactive in nature, modifying biases after they arise. Proactive cognitive control, by contrast, involves the sustained, goal-directed maintenance of positive or neutral mental sets before threatening stimuli are encountered. This study tests whether a proactive approach to thought control, delivered through modified free association and sentence completion paradigms, can more effectively shift core beliefs and cognitive biases compared to a reactive control condition.

Study Design This is a parallel-group randomized controlled trial (RCT) with a repeated-measures (pre-post) design. Participants are randomly assigned using the fishbowl block randomization technique to either: (1) the Proactive Thought Control group, or (2) the Reactive Control group (active sham condition). Counterbalancing is applied to the order of stimuli in the WSAP and Dot Probe Task to control for practice effects.

Participants Participants are university students aged 18-24 years, recruited via purposive sampling using the Liebowitz Social Anxiety Scale - Self Report (LSAS-SR). Individuals scoring above 30 on the LSAS-SR are eligible. Exclusion criteria include current psychological treatment, psychiatric or medical comorbidities, and medication use. Of 204 initially screened, 149 met the LSAS cutoff; 54 were enrolled and randomized. Final analyses include 37-39 participants who completed both pre- and post-assessments. As a pilot trial, this sample size is consistent with recommended ranges of 15-30 participants per group for feasibility and preliminary effect size estimation.

Measures

Pre- and post-intervention assessments include:

Core Belief Questionnaire (CBQ): Measures negative core beliefs about self and others in social anxiety (trait and other subscales used).

Spielberger State-Trait Anxiety Inventory - Short Form (STAI): Assesses state and trait anxiety (5 items each; 4-point Likert scale).

Word Sentence Association Paradigm (WSAP): Computerized task measuring interpretation bias; participants judge relatedness of threatening/benign word-sentence pairs. Bias scored as proportion of threatening endorsements.

Dot Probe Task: Computerized task measuring attentional bias toward threat using reaction time differences (Attentional Bias Index = mean RT threat-incongruent minus mean RT threat-congruent trials).

Screening measures include the LSAS-SR and DASS-12 (for baseline distress comparability).

Intervention The intervention comprises 180 trials divided into six blocks (framed as "game levels"): three blocks of Free Association Task (FAT) and three blocks of Sentence Completion Task (SCT). Each block contains 25 socially threatening stimuli and 5 positive/neutral stimuli, presented in randomized order.

Free Association Task (FAT): Participants see a single threatening or neutral word cue and respond with the first word that comes to mind. The proactive group is instructed to produce only positive or neutral single-word associations and cannot advance until doing so. The reactive group responds freely.

Sentence Completion Task (SCT): Participants complete unfinished sentence stems (e.g., "They stared, and I felt ___"). The proactive group must provide positive or neutral completions; the reactive group responds without restriction.

A real-time AI feedback system powered by DistilBERT-base-uncased-finetuned-SST-2-English (a lightweight transformer model fine-tuned for binary English sentiment classification) evaluates responses. Both groups receive quality-based feedback (for repetitions, spelling errors, and invalid inputs). The proactive group additionally receives sentiment-based reinforcement: +2 points and "Correct" feedback for positive/neutral responses, and corrective guidance for negative responses. The reactive group receives no sentiment feedback. This gamified point system reinforces goal-directed positive thinking in the proactive group.

Procedure Participants are recruited in-person (paper-based classroom administration) and online (Google Form). Following informed consent and LSAS/DASS screening, eligible participants complete pre-assessment (CBQ, STAI, WSAP, Dot Probe Task) via OpenSesame software, then complete the intervention tasks, followed immediately by post-assessment using the same battery.

Data Analysis Data cleaning and scoring are conducted using Excel and R (packages: jsonlite, readxl, dplyr, tidyr, stringr, writexl). Statistical analyses are conducted in SPSS and include: chi-square for attrition analysis; descriptive statistics for demographics; Mixed ANOVA for main and interaction effects (Group × Time); paired-sample t-tests for within-group pre-post comparisons; independent-sample t-tests for between-group comparisons; and ANCOVA to isolate intervention effects from baseline differences.

Being tested
Proactive Thought Conrol, Reactive Thought Control
Keywords
Social Anxiety Disorder, RCT, Proactive Thought Control, AI feedback, Core Beliefs, Cognitive Biases
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive Thought ConrolBehavioural

    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.

  • Reactive Thought ControlBehavioural

    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.

Study groups in NCT07562633
Study groupRoleWhat they receive
Proactive Thought ControlExperimentalParticipants 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.
Receives: Behavioral: Proactive Thought Conrol
Reactive Thought ControlActive comparatorParticipants 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.
Receives: Behavioral: Reactive Thought Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (1)
  1. State Trait Anxiety:Change in State-Trait Anxiety as Measured by the STAI - Short Form (STAI-State Subscale)

    The short-form State-Trait Anxiety Inventory (Zsido et al., 2020) state subscale consists of 5 items assessing temporary anxiety symptoms such as tension and apprehension. Items are rated on a 4-point Likert scale (0 = not at all to 3 = very much so), with total scores ranging from 5 to 20. Higher scores indicate greater state anxiety. Change from pre- to post-intervention is compared between groups.

    The short-form State-Trait Anxiety Inventory (Zsido et al., 2020) trait subscale consists of 5 items assessing stable individual differences in anxiety proneness. Items are rated on a 4-point Likert scale (0 = not at all to 3 = very much so), with total scores ranging from 5 to 20. Higher scores reflect greater trait anxiety. Change from pre- to post-intervention is compared between the proactive thought control and reactive control groups.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start20 Apr 2025
  3. Primary completion30 May 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07562633
Sponsor's protocol ID
GIFT/HSS/2025/PSY/1025
Other IDs
Self Funded
Acronym
PTC - SA
Status last verified
Jul 2026
First submitted
25 Apr 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 27721185
  • Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.

    PubMed 2885745
  • 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.

    PubMed 3700842
  • 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.

    PubMed 20046862
  • 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.

    PubMed 22245618
  • 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.

    PubMed 19222311

Questions about this trial

What is this clinical trial studying?

A study testing Proactive Thought Conrol in people with Social Anxiety Disorder, run by GIFT University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core Beliefs: Change in Negative Core Beliefs as Measured by the Core Belief Questionnaire (CBQ) (time frame: Baseline (pre-intervention) and immediately after intervention completion (post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07562633, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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