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Interpretation Bias Modification Training for Social Anxiety Disorder (SAD)

5. August 2026 aktualisiert von: University of Wisconsin, Milwaukee

Computerized Interpretation Bias Modification Training for Social Anxiety Disorder

The overall goal of the current study is to develop and evaluate a computerized interpretation bias modification (IBM) training for treating social anxiety disorder (SAD). A key focus is placed on enhancing accessibility and efficacy of IBM for SAD by delivering it through a mobile platform, with three specific aims outlined.

First, the current study aims to examine the efficacy of the IBM training in reducing social anxiety symptoms by comparing the pre-, post-, and follow-up assessments of the IBM group with a control group.

Second, the current study aims to examine the effect of IBM on reducing participants' daily social anxiety symptoms using daily diary methodology.

Third, the investigators also aim to evaluate the feasibility and acceptability of the IBM training. The investigators expect that at least 70% of participants will complete 4 or more of the six training sessions.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Tatsächlich)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53211
        • University of Wisconsin-Milwaukee

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Diagnosis of SAD based on the DIAMOND screening interview
  • Moderate or severe symptoms of SAD as assessed by the Liebowitz Social Anxiety Scale (LSAS score of >= 30)
  • Ages 18-60
  • English as a primary language
  • Possession of a mobile device for access to training and text message for daily diary

Exclusion Criteria:

  • Self-report visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
  • Self-reported history of a bipolar disorder or psychotic disorder as measured by Diagnostic History Scale
  • Current psychotherapy for SAD

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cognitive Bias Modification for Interpretation Bias (CBM-I)
CBM-I is designed to modify negative interpretation bias, a core cognitive characteristic of social anxiety disorder. During the training, participants will complete sentence fragments by filling in missing letters, guiding them to interpret ambiguous social scenarios in a benign way. Participants will complete the training three times per week for two weeks.
Interpretation Bias Modification Training aims to help participants interpret ambiguous social scenarios in a benign way, with the goal of reducing social anxiety symptoms. Individuals with social anxiety disorder tend to interpret ambiguous social situations negatively or catastrophize mildly negative events. This intervention targets this core cognitive characteristic by repeatedly training more adaptive interpretation. Cognitive training is delivered through mobile devices, increasing accessibility and cost-effectiveness while allowing participants to complete the intervention remotely.
Aktiver Komparator: Stress Management Psychoeducation (SMP) Group
The Stress Management Psychoeducation (SMP) group will also receive a cognitive training intervention involving the completion of sentence fragments by filling in missing letters. However, the training content will focus on stress management strategies, such as relaxation techniques and organizational skills, rather than interpretation bias modification. Participants in the SMP group will also complete the training three times per week for two weeks.
Stress Management Psychoeducation (SMP) is used as a credible comparison condition to evaluate whether CBM-I has specific therapeutic effects on reducing social anxiety symptoms. The SMP condition follows the same training format as CBM-I, in which participants complete fragmented sentences by filling in missing letters. However, the training content focuses on stress management strategies rather than modifying maladaptive interpretations of ambiguous social situations.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Brief Fear of Negative Evaluation (BFNE)
Zeitfenster: Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
The BFNE is a 12-item questionnaire, evaluating the level of apprehension and distress about expected negative evaluation. The BFNE was used to assess the cognitive symptoms of social anxiety disorder.
Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
Liebowitz Social Anxiety Scale- Self-report Version (LSAS-SR)
Zeitfenster: Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
The LSAS-SR is a 24-item scale that assesses the severity of social anxiety symptoms across two subscales: the level of anxiety (emotional reaction) and the level of avoidance (behavioral reaction). In the current study, the two subscales will be analyzed separately to evaluate the effects of the intervention on the emotional and behavioral symptoms of social anxiety.
Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Zeitfenster: Pre-training (baseline); 2-week follow-up (2 weeks after completion of the 2-week intervention)
DIAMOND is a semi-structured diagnostic interview to assess DSM-5 psychiatric disorders and has demonstrated good reliability and validity. For the current study, only the social anxiety disorder module was administered at pre-training and follow-up assessments.
Pre-training (baseline); 2-week follow-up (2 weeks after completion of the 2-week intervention)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Word Sentence Association Paradigm (WSAP)
Zeitfenster: Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
The WSAP task was used to evaluate interpretation bias in response to ambiguous situations. During the task, participants indicate whether a presented word (either negative or benign) is related or unrelated to a subsequently presented ambiguous sentence. The scenarios included both social and general situations. The percentage of endorsement responses was calculated separately for each trial type: social-threat, social-benign, general-threat, and general benign.
Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)
Daily Diary
Zeitfenster: 2 weeks of training period
Daily diary was used to evaluate participants' daily social interactions and changes in social anxiety symptoms. Participants in both groups received a text message to complete the daily diary survey each evening over the 2-week period of training. The survey first asked participants to report the social interactions they had experienced that day, followed by questions assessing anxiety, avoidance, negative self-perception, fear of negative judgment, and satisfaction related to the most stressful social interaction.
2 weeks of training period
Credibility and Expectancy Questionnaire (CEQ)
Zeitfenster: After the 1st training session
The CEQ is a self-report measure that assesses participants' perceptions of the credibility of an intervention their expectations regarding its outcomes. This measure was used to evaluate the feasibility of the CBM-I intervention.
After the 1st training session
Treatment Acceptability Questionnaire (TAQ)
Zeitfenster: 2-week follow-up (2 weeks after completion of the 2-week intervention)
The TAQ is a 5-item self-report measures that evaluates participants' perceptions of an intervention's acceptability, ethicality, acceptability of side effects, pleasantness and comfort of the intervention.
2-week follow-up (2 weeks after completion of the 2-week intervention)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. September 2024

Primärer Abschluss (Tatsächlich)

8. Dezember 2025

Studienabschluss (Tatsächlich)

8. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

17. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. August 2026

Zuerst gepostet (Tatsächlich)

7. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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