Acceptability/Feasibility Testing of SCAR

NCT04859790 | Unknown

• 1 other identifier: OWG_SCAR INTERVENTION
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Anxiety Sensitivity Index-3

  Before the intervention

• Anxiety Sensitivity Index-3

  Directly following the intervention

• Anxiety Sensitivity Index-3

  One month post intervention

• Social Phobia Scale-6

  Before the intervention

• Social Phobia Scale-6

  Directly following the intervention

Other Outcomes (34)

• Intolerance of Uncertainty Scale-12

  Before the intervention

• Intolerance of Uncertainty Scale-12

  Directly following the intervention

• Intolerance of Uncertainty Scale-12

  one month post intervention.

Study Arms (2)

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.

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.

Interventions

Social Concerns Appraisal Retraining BEHAVIORAL

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.

Active SCAR Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score ≥ 6 on the social concerns subscale of the Anxiety Sensitivity Index-3 OR score ≥ 2 on the Social Phobia Scale-6

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 31170623 BACKGROUND

• 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.

  PMID: 24534564 BACKGROUND

• 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.

  PMID: 28807519 BACKGROUND

• 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.

  PMID: 16199119 BACKGROUND

• 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.

  PMID: 28258049 BACKGROUND

• 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.

  PMID: 21856131 BACKGROUND

• 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.

  PMID: 12950439 BACKGROUND

• 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.

  PMID: 28480521 BACKGROUND

• 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.

  PMID: 19378696 BACKGROUND

• 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.

  PMID: 27062682 BACKGROUND

• 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.

  PMID: 20063929 BACKGROUND

• 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.

  PMID: 25821658 BACKGROUND

• 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.

  PMID: 24821096 BACKGROUND

• 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.

  PMID: 17563199 BACKGROUND

• Saulnier 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.

  PMID: 38014462 DERIVED

Central Study Contacts

Nicholas Allan, Ph.D.

CONTACT

740-597-2717; allan@ohio.edu

Kevin Saulnier, M.S.

CONTACT

507-469-1944; ks981615@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 26, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)