Acceptability/Feasibility Testing of SCAR

Study Overview
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Brief Summary
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Social anxiety disorder (SAD) is a prominent mental health burden, affecting more than 24 million Americans annually. Social anxiety is worsened by social isolation and severe, ongoing stress. Therefore, it is expected that the COVID-19 pandemic will significantly increase social anxiety symptoms and related impairment. Left untreated, social anxiety typically has a chronic course and a substantial impact on wellbeing. Despite the considerable impact of social anxiety, treatment for social anxiety is underutilized compared to other anxiety disorders, likely due to the distress socially anxious individuals experience upon presenting to treatment. Thus, treatments that are accessible and effective in treating social anxiety are needed. One potential to augment existing treatments for SAD is to develop brief, single-session interventions that could be administered virtually. These interventions could then be combined with additional technological innovations, such as ecological momentary intervention (EMI), to reduce social anxiety. Further, interventions targeting causal risk factors for social anxiety may be particularly beneficial, as these approaches could be used in both prevention and treatment efforts. One risk factor that represents an ideal target for interventions is anxiety sensitivity social concerns (ASSC), defined as the fear of publicly observable symptoms of anxiety (i.e., blushing, trembling, sweating). Although ASSC has been shown to be a risk factor for social anxiety, no interventions have been developed to target ASSC. In the proposed study, a brief (1 hour) virtual intervention targeting ASSC using Cognitive-Behavioral Therapy (CBT) techniques will be developed through examining the acceptability and feasibility of the SCAR intervention prototype. The proposed project holds the promise of developing an intervention to reliably reduce the impact of ASSC, both as a standalone intervention and in combination with other therapeutic approaches.

Detailed Description
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Social anxiety disorder (SAD) is a mental health disorder characterized by maladaptive distress, anxiety, and avoidance in social situations. Approximately 11% of the United States population will develop SAD in their lifetime, making SAD one of the most prevalent anxiety disorders. SAD is associated with impairment in occupational, social, and familial domains, representing a substantial economic and public health burden. Social anxiety is exacerbated by social isolation , so the effect of social anxiety has likely worsened following the COVID-19 pandemic. Despite the impact of SAD, fewer individuals seek treatment for social anxiety when compared to other common forms of mental illness (e.g., depression) even though effective treatments for social anxiety exist. To increase treatment utilization, brief interventions that target social anxiety-relevant constructs must be developed, as these interventions may be seen as more palatable among socially anxious individuals than the traditional course of treatment for SAD (lasting between 8-12 weekly 1-hour sessions). Additionally, such interventions can be easily administered virtually, reducing risk of COVID-19 transmission. Causal risk factors, defined as risk factors where a manipulation of the risk factor produces changes in the outcome, represent ideal targets for intervention. To be causal, a risk factor must concurrently relate to and longitudinally predict changes in the outcome. In addition, this risk factor must be malleable; that is, that it can change over time. Developing interventions targeting causal risk factors is an important area of research, as such interventions can both help prevent the development of mental illness and treat mental illness once it has developed. However, limited interventions have been developed that specifically target causal risk factors for social anxiety. One causal risk factor that may represent an ideal target for interventions is anxiety sensitivity social concerns (ASSC), defined as the fear of publicly observable symptoms of anxiety (e.g., blushing, trembling, sweating). ASSC is one of three dimensions of anxiety sensitivity (AS), which is the overall fear of physiological symptoms of anxiety. The other two dimensions of AS are AS physical concerns (ASPC), defined as the fear of symptoms of anxious arousal (e.g., elevated heart rate, difficulty breathing), and AS cognitive concerns (ASCC), defined as the fear of cognitive dyscontrol (e.g., racing thoughts, feeling spacy). The AS dimensions relate thematically to mental illness, with ASSC relating to social anxiety, ASPC relating to panic disorder, and ASCC relating to depression. There are brief interventions targeting overall AS and ASCC; however, no intervention targeting ASSC has been established. Given the link between ASSC and social anxiety, a brief intervention targeting ASSC will likely result in subsequent reductions in social anxiety. Objectives - Consistent with recommendations for the iterative process of intervention development the current study is designed to 1) gain shareholder feedback to refine an ASSC intervention prototype, termed the Social Concerns Appraisal Retraining (SCAR) and 2) examine acceptability and feasibility ratings for SCAR. The treatment effects of the SCAR intervention on social anxiety will also be examined. However, this will be an exploratory objective, as it is recommended to first develop acceptable and feasible interventions prior to conducting clinical trials to examine treatment effects. The final version of SCAR will consist of an hour-long intervention component, followed by a two-week-long ecological momentary intervention (EMI) component (detailed below). SCAR will be offered to clients of the Ohio University Psychology and Social Work Clinic. Grant funds will be used to cover clinic costs so that SCAR will be made available to 36 clients at the Ohio University Psychology and Social Work Clinic free of charge. Materials and Methods - The SCAR intervention was developed by adapting previous cognitive-behavioral therapy (CBT)-based AS interventions. In line with previous AS interventions, SCAR will consist of providing psychoeducation (e.g., defining common terms like anxiety), myth busting popular misconceptions clients may have about publicly observable anxiety symptoms (e.g., people can tell I'm anxious by looking at me), and completing exposure exercises (e.g., practicing facing feared physical sensations such as sweating). The SCAR intervention will be made available to clients at the Ohio University Psychology and Social Work Clinic as a pilot clinical trial. Interested clients will be randomly assigned to receive SCAR or be placed on a waitlist (for control). For participants assigned to SCAR, directly following the hour-long intervention session, they will complete a 2-week long EMI component in which they report on their social anxiety symptoms four times per day. When participants endorse elevated social anxiety during this time, they will receive a targeted message reminding them of the topics covered in SCAR. Ratings of ASSC and social anxiety will be assessed prior to receiving SCAR, after the intervention session, at the end of the EMI component, and 1-month post intervention. These ratings will be compared to those obtained in the waitlist control group. Participants assigned to the waitlist control group will complete baseline measures and measures a month after their baseline appointment. After participants in the waitlist control group complete the 1-month measures, they will be offered SCAR free of charge. Significance - The proposed study is designed to develop the first brief intervention targeting ASSC. ASSC is a causal risk factor for SAD, a chronic mental health condition that has a substantial impact on public health. Once developed, SCAR will be used in conjunction with treatments for SAD and in prevention efforts among individuals at risk for developing SAD.

Official Title
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Acceptability/Feasibility Testing of a Virtual Intervention Targeting Anxiety Sensitivity Social Concern

Conditions
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Social Anxiety

Intervention / Treatment
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* Behavioral: Social Concerns Appraisal Retraining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score ≥ 6 on the social concerns subscale of the Anxiety Sensitivity Index-3 OR score ≥ 2 on the Social Phobia Scale-6 Exclusion Criteria: Suicidal ideation indicative of a need for hospitalization Uncontrolled manic or psychotic-spectrum symptoms Not having internet access or owning a smartphone Not fluent English speaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to the active condition or a waitlist control condition. Participants assigned to the active condition will complete baseline measures and receive the SCAR intervention. They would then complete follow-up measures one month after they completed the SCAR intervention. Participants assigned to the waitlist control condition will complete baseline measures and follow-up measures after a month. They will be offered the SCAR intervention after they complete the follow-up measures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active SCAR Intervention<br>In this arm, participants will complete baseline measures, receive the SCAR intervention, and complete follow-up measures one month following the intervention. | Behavioral: Social Concerns Appraisal Retraining<br>* SCAR consists of an hour-long intervention session, followed by a 2-week-long EMI. During the hour-long intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety), discuss popular misconceptions they may have about publicly observable anxiety symptoms (e.g., people can tell I'm anxious by looking at me), and complete exposure exercises (e.g., practicing facing feared physical sensations such as sweating). During the EMI, participants will report on their social anxiety symptoms four times per day. When participants endorse elevated social anxiety during this time, they will receive a targeted message reminding them of the topics covered in the intervention session.<br>|
| No Intervention: Waitlist Control<br>Participants assigned to the waitlist control condition will complete baseline measures and measures one month following their baseline appointment. After they complete the follow-up measures, they will be offered the SCAR intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire-8 | An average Client Satisfaction Questionnaire-8 rating of > 3 (on a 4-point scale) for a study component will provide support for the acceptability and feasibility of this intervention. Scores range from 8-32 with higher scores indicating greater satisfaction. | Directly following the intervention | 
| Client Satisfaction Questionnaire-8 | An average Client Satisfaction Questionnaire-8 rating of > 3 (on a 4-point scale) for a study component will provide support for the acceptability and feasibility of this intervention. Scores range from 8-32 with higher scores indicating greater satisfaction. | One month post intervention. | 
| Ecological Momentary Intervention Completion Rate | The percentage of completed ecological momentary intervention prompts will be used as a measure of acceptability and feasibility. The Ecological Momentary Intervention will be considered feasible if > 80 percent of the Ecological Momentary Intervention sessions are completed by > 80 percent of participants, as done in previous studies (LaFreniere & Newman, 2016; Lucas-Thompson et al., 2019). | The Ecological Momentary Intervention will directly follow the intervention. Prompts will be delivered four times per day for two weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Sensitivity Index-3 | Anxiety Sensitivity Index-3 - 18-item measure assessing anxiety sensitivity. Scores range from 0-72 with higher scores indicating more anxiety sensitivity | Before the intervention | 
| Anxiety Sensitivity Index-3 | Anxiety Sensitivity Index-3 - 18-item measure assessing anxiety sensitivity. Scores range from 0-72 with higher scores indicating more anxiety sensitivity | Directly following the intervention | 
| Anxiety Sensitivity Index-3 | Anxiety Sensitivity Index-3 - 18-item measure assessing anxiety sensitivity. Scores range from 0-72 with higher scores indicating more anxiety sensitivity | One month post intervention | 
| Social Phobia Scale-6 | Social Phobia Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | Before the intervention | 
| Social Phobia Scale-6 | Social Phobia Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | Directly following the intervention | 
| Social Phobia Scale-6 | Social Phobia Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | One month post intervention. | 
| Social Interaction Anxiety Scale-6 | Social Interaction Anxiety Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | Before the intervention | 
| Social Interaction Anxiety Scale-6 | Social Interaction Anxiety Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | Directly following the intervention | 
| Social Interaction Anxiety Scale-6 | Social Interaction Anxiety Scale-6 - 6-item measure assessing social anxiety. Scores range from 0-24 with higher scores indicating more social anxiety | One month post intervention. |