- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Gujranwala, Punjab Province, Pákistán, 52250
- GIFT University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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:
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Core Beliefs: Change in Negative Core Beliefs as Measured by the Core Belief Questionnaire (CBQ)
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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State Trait Anxiety:Change in State-Trait Anxiety as Measured by the STAI - Short Form (STAI-State Subscale)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Baseline Depression, Anxiety, and Stress Levels as Measured by the DASS-12
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GIFT/HSS/2025/PSY/1025
- self funded (Jiný identifikátor: Cairo University)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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