- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07810348
Effectiveness of an AI-Integrated Proactive Thought Control Intervention for Young Adults With Social Anxiety Disorder
3 septembre 2026 mis à jour par: Farah Shahzadi
The Objective is to Examine the Effectiveness of Ai Integrated Proactive Thought Control for Social Anxiety Disorder and Compare Its Effectiveness With Active Control Group and Cognitive Behavioral Therapy. Participants With SAD Will be Recruited From Educational Setting, Will Get 8 Therapy Sessions.
Participants with Social Anxiety Disorder will be recruited from educational settings .
After screening and informed consent, participants will be randomly assigned to PTC , ACG or CBT .The therapy session will be 8 session once a week, and data will be collected through psychological questionnaires in two phases at start and end of intervention.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
75
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Punjab Province
-
Gujranwala, Punjab Province, Pakistan
- Farah Shahzadi
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Were between 18 and 26 years of age, corresponding to the developmental period of emerging adulthood (Arnett, 2000).
- Met DSM-5 diagnostic criteria for Social Anxiety Disorder on the SCID-5-RV (First et al., 2015).
- Scored at or above the clinical cutoff of 30 on the LSAS-SR, indicating clinically significant social anxiety (Mennin et al., 2002).
- Were not receiving any other form of psychological intervention at the time of the study.
- Had sufficient English proficiency to understand instructions and complete the assessments (Flores, 2006).
- Provided written informed consent.
- Possessed basic computer literacy and typing skills required for the digital tasks.
Exclusion Criteria:
- Were younger than 18 or older than 26 years.
- Did not meet DSM-5 diagnostic criteria for Social Anxiety Disorder on the SCID-5-RV.
- Scored in the clinically significant range for general anxiety (BAI ≥ 16; Beck et al., 1988) or at or above the threshold for moderate depression (BDI-II ≥ 20; Beck et al., 1996).
- Were currently receiving psychological treatment for any psychiatric condition.
- Had a lifetime history of a severe psychiatric disorder other than Social Anxiety Disorder (e.g., psychosis, bipolar disorder).
- Had a medical or neurological condition that could interfere with task completion or valid responding.
- Were unable to complete the study procedures or assessments.
- Had no prior experience using a computer.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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 |
|---|---|
|
Expérimental: proactive thought control
The PTC (Proactive Thought Control) arm an AI-integrated, computerized intervention that trains proactive thought control, the anticipatory maintenance of a positive goal representation used to override an automatically primed negative response before it is produced (Braver, 2012).
Across eight sessions, each pairing a Free Association Task (single-word cues) with a Sentence Completion Task (unfinished social-evaluative stems).
|
The two paired tasks Free Association Task (FAT) and Sentence Completion Task (SCT) form the core of the AI-integrated Proactive Thought Control (PTC) program.
FAT shows a social-threat word and the participant types the first associated word, training proactive control at the lexical level; SCT then gives unfinished social-evaluative stems to complete with a benign word, extending the override to the propositional level.
Both run three blocks of thirty self-paced trials per session (720 over two weeks), so every threat trial forces a positive, cue-relevant representation that overrides a primed negative associate before advancing.
AI integration relies on real-time validation: SiEBERT scores sentiment and MiniLM embedding confirm semantic relevance, enforcing a positive, cue-relevant construal each trial.
Feedback reinforces this accepted responses earn points, rejected one prompt revision, and the threshold relaxes after four failures and pass after eight.
|
|
Comparateur actif: Cognitive Behavior Therapy
The CBT group served as the gold-standard comparison condition, receiving an eight-session, individually delivered cognitive-behavioral protocol adapted from the empirically supported treatment of Hope, Heimberg, and Turk (2019).
To fit the study's fixed eight-session frame, it followed the manual's accelerated outline, compressing the standard sixteen-to-twenty-session course while still covering most relevant workbook chapters in order.
|
8-session CBT protocol ( Hope, Heimberg & Turk, 2019 manual) The CBT arm received an eight-session protocol moving from psychoeducation and the three-component model of social anxiety with an individualized Fear and Avoidance Hierarchy (Sessions 1-2), through cognitive restructuring using disputing questions from automatic thought to rational response (Sessions 3-4), to repeated graded exposure using role-plays, distress ratings, and added cognitive tools, with the final session offering core-belief work and setting post-treatment maintenance goals (Sessions 5-8)
|
|
Comparateur actif: Active Control Group
The Active Control group was a structurally and temporally matched, computerized active comparison condition that removed the intervention's active ingredient while preserving every non-specific feature.
Participants completed the same two tasks (Free Association and Sentence Completion), the same cue/stem material, same three blocks of 30 trials per session (720 across eight sessions), same self-paced presentation, practice trials, on-screen appearance, and time on task, so the two conditions were equated on stimuli, dose, feedback salience, and engagement.
The key difference was the omission of the proactive-thought-control contingency.
|
Participants did the same two tasks as the experimental group.
The Free Association Task and the Sentence Completion Task , matched on stimuli, format, and time.
The key difference was that the control removed the core training element: responses were not checked for meaning against the cue, and about half of the negative answers were accepted without correction, so the link between a threat cue and forcing a positive response was broken.
In short, the control group did the same tasks and got the same exposure, but without the active thinking-training component.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Liebowitz Social Anxiety Scale-Self Report
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
Liebowitz Social Anxiety Scale-Self-Report; range 0-144; higher = worse (greater social anxiety severity)
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
|
Core Belief Questionnaire (CBQ)
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
Core Belief Questionnaire-Self-Trait and -Other (17 items each, 6-point Likert); range 17-102 if items are scored 1-6; higher = more strongly endorsed negative core beliefs (worse)".
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
|
Dot Probe task
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
milliseconds; more positive = stronger bias toward social threat
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
|
word sentence association paradigm
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
higher = more threat-relevant interpretation bias
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
|
Behavioral Avoidance Task
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
SUDS 0-100; higher = more subjective distress
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
beck depression inventory II
Délai: Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
range 0-63; higher = worse
|
Baseline (Day 1, before the first session) and Post-Intervention (within 7 days after the eighth session; the 8 sessions are delivered a weekly over a 8-week period
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 mars 2026
Achèvement primaire (Réel)
12 août 2026
Achèvement de l'étude (Réel)
14 août 2026
Dates d'inscription aux études
Première soumission
29 août 2026
Première soumission répondant aux critères de contrôle qualité
3 septembre 2026
Première publication (Réel)
9 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GIFT/PSY/MS/2025/004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .