Social AnxietyNCT04859790
Acceptability/Feasibility Testing of SCAR
A study testing Social Concerns Appraisal Retraining in people with Social Anxiety, run by Ohio University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Social Concerns Appraisal Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score ≥ 6 on the social concerns subscale of the Anxiety Sensitivity Index-3 OR score ≥ 2 on the Social Phobia Scale-6
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ohio University
Athens, Ohio, 45701
Nicholas P Allan, PhD
About this study
Official title: Acceptability/Feasibility Testing of a Virtual Intervention Targeting Anxiety Sensitivity Social Concern
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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Social Concerns Appraisal Retraining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Concerns Appraisal RetrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active SCAR Intervention | Active comparator | In this arm, participants will complete baseline measures, receive the SCAR intervention, and complete follow-up measures one month following the intervention. Receives: Behavioral: Social Concerns Appraisal Retraining |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: The Ecological Momentary Intervention will directly follow the intervention. Prompts will be delivered four times per day for two weeks.
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: One month post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Sep 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Allan, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859790
- Sponsor's protocol ID
- OWG_SCAR INTERVENTION
- Status last verified
- Sep 2021
- First submitted
- 1 Apr 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31170623Allan 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.
PubMed 24534564Allan 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.
PubMed 28807519Butler 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.
PubMed 16199119Chow 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.
PubMed 28258049Drummond 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.
PubMed 21856131Keller 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.
PubMed 12950439Kelly 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.
PubMed 28480521Kessler 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.
PubMed 19378696LaFreniere 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.
PubMed 27062682Naragon-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.
PubMed 20063929Onken 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.
PubMed 25821658Schmidt 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.
PubMed 24821096Taylor 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.
PubMed 17563199Saulnier KG, Koscinski B, Flynt S, Accorso C, Allan NP. Brief observable anxiety sensitivity treatment: intervention development and a pilot randomized-controlled acceptability and feasibility trial to evaluate a brief intervention for anxiety sensitivity social concerns. Cogn Behav Ther. 2024 Mar;53(2):190-206. doi: 10.1080/16506073.2023.2288551. Epub 2023 Nov 28.
PubMed 38014462
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability/Feasibility Testing of a Virtual Intervention Targeting Anxiety Sensitivity Social Concern
- ClinicalTrials.gov ID
- NCT04859790
- Acronym / sponsor ID
- OWG_SCAR INTERVENTION
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active SCAR Intervention | Active comparator | Behavioral: Social Concerns Appraisal RetrainingIn this arm, participants will complete baseline measures, receive the SCAR intervention, and complete follow-up measures one month following the intervention. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Score ≥ 6 on the social concerns subscale of the Anxiety Sensitivity Index-3 OR score ≥ 2 on the Social Phobia Scale-6
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Concerns Appraisal RetrainingSCAR 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. | Behavioural | Active SCAR Intervention |
Primary outcome
Client Satisfaction Questionnaire-8
Time frame: Directly following the intervention
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.
Client Satisfaction Questionnaire-8
Time frame: One month post intervention.
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.
Ecological Momentary Intervention Completion Rate
Time frame: The Ecological Momentary Intervention will directly follow the intervention. Prompts will be delivered four times per day for two weeks.
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).
9 secondary outcomes
Anxiety Sensitivity Index-3
Time frame: Before the intervention
Anxiety Sensitivity Index-3
Time frame: Directly following the intervention
Anxiety Sensitivity Index-3
Time frame: One month post intervention
Social Phobia Scale-6
Time frame: Before the intervention
Social Phobia Scale-6
Time frame: Directly following the intervention
Social Phobia Scale-6
Time frame: One month post intervention.
Social Interaction Anxiety Scale-6
Time frame: Before the intervention
Social Interaction Anxiety Scale-6
Time frame: Directly following the intervention
Social Interaction Anxiety Scale-6
Time frame: One month post intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 31170623Allan 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.
- Background: PubMed 24534564Allan 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.
- Background: PubMed 28807519Allan 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.
- Background: PubMed 16199119Butler 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.
- Background: PubMed 28258049Chow 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Concerns Appraisal Retraining in people with Social Anxiety, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Allan, Ph.D. (740-597-2717, allan@ohio.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (time frame: Directly following the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859790, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.