Social anxiety disorder
Conditions
Interventions
Intervention: iCT-SAD + TAU, therapist-guided modular online cognitive therapy for social anxiety based on the Clark and Wells (1995) cognitive model in addition to treatment as usual (14 weeks + 3-mo
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary diagnosis of SAD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) - Aged 18 years or over - Regular, private access to an appropriate internet enable device - Resident in Japan and proficient in Japanese (written and spoken) - Able to visit their primary psychiatrist regularly during the study (at least monthly in person) for safety monitoring - Participant not currently undertaking other structured psychological therapy and agrees not to start such interventions during the study
Exclusion criteria
Exclusion criteria: - Current psychosis, bipolar disorder, or antisocial personality disorder - Current alcohol/substance use disorder (moderate or severe) - Active suicidal ideation with intent or plan - Previously received CT or cognitive behavioural therapy for SAD (defined as at least 5 sessions and including an exposure component)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liebowitz Social Anxiety Scale (LSAS) (self-report) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] | — |
Secondary
| Measure | Time frame |
|---|---|
| [efficacy measures] - Proportion of participants who met the SAD diagnostic criteria evaluated using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) [Pre (week 0), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Social Cognitions Questionnaire (SCQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Social Behavioural Questionnaire (SBQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Social Attitudes Questionnaire (SAQ) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Social Phobia Weekly Summary Scale (SPWSS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Social Participation and Satisfaction Scale (SPSS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Patient Health Questionnaire-9 (PHQ-9) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Generalized Anxiety Disorder-7 (GAD-7) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] - Work and Social Adjustment Scale (WSAS) [Pre (week 0), Mid (week 8), Post (week 15), 3-mo FU (week 27, Intervention arm only)] [response to treatment] - Response: Improvement in the LSAS between pre- and post-treatment greater than 31% - Remission: Decrease in the LSAS score of at least 12 points and post-treatment score of 38 points or less - Reliable deterioration: Increase of at least 12 points in the LSAS score [acceptability measures] - Dropout rate - Rates of module completion (Intervention arm only) - Participants' feedback about their experience with iCT-SAD (Intervention arm only) | — |
Countries
Japan
Contacts
Public ContactNaoki Yoshinaga
University of Miyazaki School of Nursing, Faculty of Medicine
Outcome results
None listed