University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211, United States
NCT Number: NCT07753538
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53211, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Wisconsin, Milwaukee
Other
Computerized Interpretation Bias Modification Training for Social Anxiety Disorder
Acronym: SAD
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