- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07562633
Proactive Thought Control for Social Anxiety Relief (PTC - SA)
The Effectiveness of Proactive Thought Control in Modification of Negative Core Beliefs and Cognitive Biases in Individual With Social Anxiety: A Pilot RCT Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Punjab Province
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Gujranwala, Punjab Province, Pakistan, 52250
- GIFT University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria
- 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
- 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:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Proactive Thought Control
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.
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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.
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Comparateur actif: Reactive Thought Control
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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Core Beliefs: Change in Negative Core Beliefs as Measured by the Core Belief Questionnaire (CBQ)
Délai: Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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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.
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Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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Interpretation Biases: Change in Interpretation Bias as Measured by the Word Sentence Association Paradigm (WSAP)
Délai: Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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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.
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Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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Attentional Biases: Change in Attentional Bias as Measured by the Dot Probe Task
Délai: Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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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.
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Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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State Trait Anxiety:Change in State-Trait Anxiety as Measured by the STAI - Short Form (STAI-State Subscale)
Délai: Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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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. |
Baseline (pre-intervention) and immediately after intervention completion (post-intervention)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Baseline Depression, Anxiety, and Stress Levels as Measured by the DASS-12
Délai: Screening only
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The DASS-12 (Monteiro et al., 2023) is a 12-item self-report measure with three 4-item subscales assessing depression, anxiety, and stress over the past week.
Items are rated on a 4-point Likert scale (0 = did not apply at all to 3 = applied most of the time).
It is used at screening only to verify baseline equivalence between groups and to control for the influence of general distress on intervention outcomes.
It is not used as a primary or secondary outcome measure.
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Screening only
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GIFT/HSS/2025/PSY/1025
- self funded (Autre identifiant: Faculty of Dentistry, Ain Shams University Research Ethics Committee (FDASU-REC))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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