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The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT) | Experimental |
| |
| CBT alone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | Participants will receive will receive 12 weeks of weekly CBT for Social Anxiety, including an intervention to improve conversational skills. The CBT for Social Anxiety will include "imaginal exposure", which is a way of using the imagination to work with situations that produce anxiety. Participants will also receive a mindfulness intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS) | This is a 24 item questionnaire, each is assessed in 2 ways measuring both fear/anxiety and avoidance related to specific social situations, giving a total of 48 ratings across the scale. The questions are scored from 0 (none) to 3 (severe) for a score range of 0-144 higher score indicating worse outcome. | Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)) |
| Change in anxiety as assessed by the Social Interaction Anxiety Scale (SIAS) | This is a 20 item questionnaire and each is scored on a likert scale from 0(not at all characteristic of me)-4(Extremely characteristic of me), maximum score of 80,higher score indicating worse outcome | Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment) |
| Change in anxiety as assessed by the Social Phobia Scale (SPS) | This is a 20 item questionnaire and each is scored on a likert scale from 0-4, maximum score of 80 , higher score indicating worse outcome | Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment) |
| Change in anxiety as assessed by the The Severity Measure for Social Anxiety Disorder (SMSAD) scale | This is a 10 item questionnaire and each is scored from 0(never) to 4(all of the time) for a maximum score of 40, higher score indicating worse outcome | Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Loveland, PhD | Contact | 713-486-2587 | Katherine.A.Loveland@uth.tmc.edu | |
| Craig Motsenbocker, PhD | Contact | (713) 486-2700 | craig.m.motsenbocker@uth.tmc.edu) |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Loveland, PhD | The University of Texas Health Science Center at Houstom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| VR | Device | The VR software, the Virtual Communicator (VC) consists of a highly realistic avatar that interacts with the client in one of several situations. The therapist controls its gestures, facial expressions, body movements, and speech and builds and saves modular combinations of gestures and facial expressions that can be assembled in any order to create a conversational interaction. The software has two adult avatars of ambiguous race/ethnicity, male and female. The VC is delivered without a headset interactively over the internet, on a secure, password-protected connection that increase access by not requiring headsets and not requiring the client to come to the office. The VC can be done in English, or in Spanish where appropriate. Treatment will be done for 12 sessions. The VR software is used to provide CBT exposures to reduce anxiety and also to practice social interactions. |
|
| D001008 | Anxiety Disorders |