- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07810348
Effectiveness of an AI-Integrated Proactive Thought Control Intervention for Young Adults With Social Anxiety Disorder
3 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
75
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Punjab Province
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Gujranwala, Punjab Province, Pakistan
- Farah Shahzadi
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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).
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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.
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Aktywny komparator: 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.
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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)
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Aktywny komparator: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Liebowitz Social Anxiety Scale-Self Report
Ramy czasowe: 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
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Liebowitz Social Anxiety Scale-Self-Report; range 0-144; higher = worse (greater social anxiety severity)
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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
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Core Belief Questionnaire (CBQ)
Ramy czasowe: 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
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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)".
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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
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Dot Probe task
Ramy czasowe: 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
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milliseconds; more positive = stronger bias toward social threat
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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
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word sentence association paradigm
Ramy czasowe: 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
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higher = more threat-relevant interpretation bias
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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
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Behavioral Avoidance Task
Ramy czasowe: 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
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SUDS 0-100; higher = more subjective distress
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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beck depression inventory II
Ramy czasowe: 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
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range 0-63; higher = worse
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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
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 marca 2026
Zakończenie podstawowe (Rzeczywisty)
12 sierpnia 2026
Ukończenie studiów (Rzeczywisty)
14 sierpnia 2026
Daty rejestracji na studia
Pierwszy przesłany
29 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 września 2026
Pierwszy wysłany (Rzeczywisty)
9 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
9 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GIFT/PSY/MS/2025/004
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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