Clinical trial NCT04859790: Acceptability/Feasibility Testing of SCAR
Official title: Acceptability/Feasibility Testing of a Virtual Intervention Targeting Anxiety Sensitivity Social Concern
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire-8
timeFrame: Directly following the intervention
measure: Client Satisfaction Questionnaire-8
timeFrame: One month post intervention.
measure: Ecological Momentary Intervention Completion Rate
timeFrame: The Ecological Momentary Intervention will directly follow the intervention. Prompts will be delivered four times per day for two weeks.
Secondary outcomes:
measure: Anxiety Sensitivity Index-3
timeFrame: Before the intervention
measure: Anxiety Sensitivity Index-3
timeFrame: Directly following the intervention
measure: Anxiety Sensitivity Index-3
timeFrame: One month post intervention
measure: Social Phobia Scale-6
timeFrame: Before the intervention
measure: Social Phobia Scale-6
timeFrame: Directly following the intervention
measure: Social Phobia Scale-6
timeFrame: One month post intervention.
measure: Social Interaction Anxiety Scale-6
timeFrame: Before the intervention
measure: Social Interaction Anxiety Scale-6
timeFrame: Directly following the intervention
measure: Social Interaction Anxiety Scale-6
timeFrame: One month post intervention.
Other outcomes:
measure: Intolerance of Uncertainty Scale-12
timeFrame: Before the intervention
measure: Intolerance of Uncertainty Scale-12
timeFrame: Directly following the intervention
measure: Intolerance of Uncertainty Scale-12
timeFrame: one month post intervention.
measure: Patient Health Questionnaire-9
timeFrame: Before the intervention
measure: Patient Health Questionnaire-9
timeFrame: directly following the intervention
measure: Patient Health Questionnaire-9
timeFrame: one month post intervention.
measure: Brief Penn State Worry Questionnaire
timeFrame: Before the intervention
measure: Brief Penn State Worry Questionnaire
timeFrame: directly following the intervention
measure: Brief Penn State Worry Questionnaire
timeFrame: one month post intervention.
measure: Attentional Control Scale - Straightforward
timeFrame: Before the intervention
measure: Attentional Control Scale - Straightforward
timeFrame: directly following the intervention
measure: Attentional Control Scale - Straightforward
timeFrame: one month post intervention.
measure: Brief Fear of Negative Evaluation-II
timeFrame: Before the intervention
measure: Brief Fear of Negative Evaluation-II
timeFrame: directly following the intervention
measure: Brief Fear of Negative Evaluation-II
timeFrame: one month post intervention.
measure: Panic Disorder Severity Scale
timeFrame: Before the intervention
measure: Panic Disorder Severity Scale
timeFrame: directly following the intervention
measure: Panic Disorder Severity Scale
timeFrame: one month post intervention.
measure: Alcohol Use Disorders Identification Test
timeFrame: Before the intervention
measure: Alcohol Use Disorders Identification Test
timeFrame: directly following the intervention
measure: Alcohol Use Disorders Identification Test
timeFrame: one month post intervention.
measure: Loneliness Questionnaire
timeFrame: Before the intervention
measure: Loneliness Questionnaire
timeFrame: directly following the intervention
measure: Loneliness Questionnaire
timeFrame: one month post intervention.
measure: COVID Behavior Questionnaire
timeFrame: Before the intervention
measure: COVID Behavior Questionnaire
timeFrame: directly following the intervention
measure: COVID Behavior Questionnaire
timeFrame: one month post intervention.
measure: COVID Worry Questionnaire
timeFrame: Before the intervention
measure: COVID Worry Questionnaire
timeFrame: directly following the intervention
measure: COVID Worry Questionnaire
timeFrame: one month post intervention.
measure: Momentary Anxiety Sensitivity Index-3 Social Concerns Subscale
timeFrame: During the Ecological Momentary Intervention portion of the intervention assessed up to 14 days
measure: Momentary Social Phobia Scale-6
timeFrame: During the Ecological Momentary Intervention portion of the intervention assessed up to 14 days
measure: Momentary Anxiety Depression Distress Inventory-27 - Anxious Arousal Subscale
timeFrame: During the Ecological Momentary Intervention portion of the intervention assessed up to 14 days
measure: Momentary Brief Penn State Worry Questionnaire
timeFrame: During the Ecological Momentary Intervention portion of the intervention assessed up to 14 days
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References:
citation: Allan NP, Saulnier KG, Cooper D, Oglesby ME, Schmidt NB. Niacin biological challenge: A paradigm to evaluate social concerns. J Behav Ther Exp Psychiatry. 2019 Dec;65:101489. doi: 10.1016/j.jbtep.2019.101489. Epub 2019 May 30.
citation: Allan NP, Capron DW, Raines AM, Schmidt NB. Unique relations among anxiety sensitivity factors and anxiety, depression, and suicidal ideation. J Anxiety Disord. 2014 Mar;28(2):266-75. doi: 10.1016/j.janxdis.2013.12.004. Epub 2013 Dec 27.
citation: Allan NP, Cooper D, Oglesby ME, Short NA, Saulnier KG, Schmidt NB. Lower-order anxiety sensitivity and intolerance of uncertainty dimensions operate as specific vulnerabilities for social anxiety and depression within a hierarchical model. J Anxiety Disord. 2018 Jan;53:91-99. doi: 10.1016/j.janxdis.2017.08.002. Epub 2017 Aug 7.
citation: Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
citation: Chow PI, Fua K, Huang Y, Bonelli W, Xiong H, Barnes LE, Teachman BA. Using Mobile Sensing to Test Clinical Models of Depression, Social Anxiety, State Affect, and Social Isolation Among College Students. J Med Internet Res. 2017 Mar 3;19(3):e62. doi: 10.2196/jmir.6820.
citation: Drummond PD, Lazaroo D. The effect of niacin on facial blood flow in people with an elevated fear of negative evaluation. Eur Neuropsychopharmacol. 2012 Mar;22(3):200-4. doi: 10.1016/j.euroneuro.2011.07.013.
citation: Keller MB. The lifelong course of social anxiety disorder: a clinical perspective. Acta Psychiatr Scand Suppl. 2003;(417):85-94. doi: 10.1034/j.1600-0447.108.s417.6.x.
citation: Kelly PJ, Kyngdon F, Ingram I, Deane FP, Baker AL, Osborne BA. The Client Satisfaction Questionnaire-8: Psychometric properties in a cross-sectional survey of people attending residential substance abuse treatment. Drug Alcohol Rev. 2018 Jan;37(1):79-86. doi: 10.1111/dar.12522. Epub 2017 May 7.
citation: Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.
citation: LaFreniere LS, Newman MG. A BRIEF ECOLOGICAL MOMENTARY INTERVENTION FOR GENERALIZED ANXIETY DISORDER: A RANDOMIZED CONTROLLED TRIAL OF THE WORRY OUTCOME JOURNAL. Depress Anxiety. 2016 Sep;33(9):829-39. doi: 10.1002/da.22507. Epub 2016 Apr 7.
citation: Naragon-Gainey K. Meta-analysis of the relations of anxiety sensitivity to the depressive and anxiety disorders. Psychol Bull. 2010 Jan;136(1):128-50. doi: 10.1037/a0018055.
citation: Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health. Clin Psychol Sci. 2014 Jan 1;2(1):22-34. doi: 10.1177/2167702613497932.
citation: Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.
citation: Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, Abramowitz JS, Holaway RM, Sandin B, Stewart SH, Coles M, Eng W, Daly ES, Arrindell WA, Bouvard M, Cardenas SJ. Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007 Jun;19(2):176-88. doi: 10.1037/1040-3590.19.2.176.