Interpretation Bias Modification Training for Social Anxiety Disorder (SAD)
5 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53211
- University of Wisconsin-Milwaukee
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brief Fear of Negative Evaluation (BFNE)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Word Sentence Association Paradigm (WSAP)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Mobini S, Mackintosh B, Illingworth J, Gega L, Langdon P, Hoppitt L. Effects of standard and explicit cognitive bias modification and computer-administered cognitive-behaviour therapy on cognitive biases and social anxiety. J Behav Ther Exp Psychiatry. 2014 Jun;45(2):272-9. doi: 10.1016/j.jbtep.2013.12.002. Epub 2013 Dec 31.
- Beard C, Amir N. A multi-session interpretation modification program: changes in interpretation and social anxiety symptoms. Behav Res Ther. 2008 Oct;46(10):1135-41. doi: 10.1016/j.brat.2008.05.012. Epub 2008 Jun 27.
- Beard C. Cognitive bias modification for anxiety: current evidence and future directions. Expert Rev Neurother. 2011 Feb;11(2):299-311. doi: 10.1586/ern.10.194.
- Amir N, Prouvost C, Kuckertz JM. Lack of a benign interpretation bias in social anxiety disorder. Cogn Behav Ther. 2012;41(2):119-29. doi: 10.1080/16506073.2012.662655. Epub 2012 Apr 30.
- Patel TA, Schubert FT, Hom MA, Cougle JR. Correlates of treatment seeking in individuals with social anxiety disorder: Findings from a nationally representative sample. J Anxiety Disord. 2022 Oct;91:102616. doi: 10.1016/j.janxdis.2022.102616. Epub 2022 Aug 6.
- Liu H, Li X, Han B, Liu X. Effects of cognitive bias modification on social anxiety: A meta-analysis. PLoS One. 2017 Apr 6;12(4):e0175107. doi: 10.1371/journal.pone.0175107. eCollection 2017.
- Heinrichs N, Hofmann SG. Information processing in social phobia: a critical review. Clin Psychol Rev. 2001 Jul;21(5):751-70. doi: 10.1016/s0272-7358(00)00067-2.
- Cougle JR, Wilver NL, Day TN, Summers BJ, Okey SA, Carlton CN. Interpretation Bias Modification Versus Progressive Muscle Relaxation for Social Anxiety Disorder: A Web-Based Controlled Trial. Behav Ther. 2020 Jan;51(1):99-112. doi: 10.1016/j.beth.2019.05.009. Epub 2019 May 24.
- Clark DM, McManus F. Information processing in social phobia. Biol Psychiatry. 2002 Jan 1;51(1):92-100. doi: 10.1016/s0006-3223(01)01296-3.
- Amir N, Taylor CT. Interpretation training in individuals with generalized social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):497-511. doi: 10.1037/a0026928. Epub 2012 Jan 16.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de septiembre de 2024
Finalización primaria (Actual)
8 de diciembre de 2025
Finalización del estudio (Actual)
8 de diciembre de 2025
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
7 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UWM 25.022
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .