Brief Enhanced Anxiety Sensitivity Treatment (Group)

NCT05458362 | Completed

• 1 other identifier: Group_BEAST
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

One-third of the U.S. population experience anxiety disorders in their lifetime and only 25% of them seek treatment, reporting logistics and cost of treatment among the primary barriers. A potential way to prevent and treat multiple anxiety disorders is to target the risk factors that contribute to their etiology. One such well-researched risk factor is anxiety sensitivity (AS), a fear of anxiety-related sensations. Given a need for affordable and accessible brief treatments, we and our colleagues have been iteratively developing Brief Enhanced Anxiety Sensitivity Treatment (BEAST), a one-session virtual treatment targeting AS. Older versions of BEAST include psychoeducation, interoceptive exposure (IE), and IE homework. Several studies showed that the previous versions of BEAST reduced AS and, through the reductions in AS, they also reduced anxiety. However, the effect sizes for the decrease in anxiety were modest. Efficacy and personalization may be improved using Ecological Momentary Intervention (EMI). EMI delivers brief interventions remotely in real-time and in natural settings. The goal of the current study is to test the efficacy of adding EMI to BEAST. Participants will be randomly assigned to EMI and control (no EMI) conditions. All participants will receive a virtual 1.5-hour-long intervention group session facilitated by a therapist. The EMI group will receive individualized intervention messages helping them to use new skills for two weeks after the session. After the two-week EMI period, all participants will complete post-treatment measures of AS and anxiety. A month later, they will complete a follow-up assessing AS and anxiety. The efficacy of the EMI component in reducing AS and anxiety will be tested using multilevel modeling. Improving the efficacy of BEAST, while keeping it brief, affordable, and accessible online, is an important step towards making it a treatment that may be used on a large scale.

Conditions

Anxiety Sensitivity; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety Sensitivity Inventory-3 (ASI-3; Taylor et al., 2007)

  The ASI-3 is an 18-item self-report questionnaire of anxiety sensitivity measured on a 5-point Likert-like scale ranging from 0 (very little) to 4 (very much).

  Screening, baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.

• Change in PROMIS Anxiety scale - 8a

  The PROMIS Anxiety scale measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always).

  Baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.

Secondary Outcomes (3)

• Change multiple times a day - EMI anxiety questions (EMI group)

  2 weeks of EMI - 4 times a day

• Daily change - Short Scale Anxiety Sensitivity Index (all participants)

  2 weeks of EMI - 1 time a day

• Daily change - PROMIS Anxiety Short Form 8a Modified (all participants)

  2 weeks of EMI - 1 time a day

Other Outcomes (4)

• Demographic questionnaire

  Baseline

• Change in PROMIS Depression scale - 8a

  Baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.

• Change in PROMIS Psychological Stress scale - 8a

  Baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.

Study Arms (2)

EMI group

EXPERIMENTAL

For two weeks after the intervention session, participants will report on their anxiety level four times per day. When participants endorse elevated anxiety, they will receive a message relevant to their most stressful symptom at the moment reminding them of the topics covered in the intervention session. As the efficacy of the EMI component is being tested, only the EMI group will receive EMI.

Behavioral: Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST)

Control group

ACTIVE COMPARATOR

The control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment.

Behavioral: Control group Anxiety Sensitivity Treatment

Interventions

Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST) BEHAVIORAL

Group BEAST consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework. Only the EMI group will receive EMI prompts and intervention.

EMI group

Control group Anxiety Sensitivity Treatment BEHAVIORAL

Control group Anxiety Sensitivity Treatment consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elevated anxiety sensitivity symptoms (i.e., ASI-3 scores greater than or equal to 17),
• have access to a device smartphone with internet connection.

You may not qualify if:

• cardiovascular disease or stroke
• respiratory disorders (asthma, COPD, other),
• renal disease,
• epilepsy or other seizure disorder,
• and uncontrolled hypertension or migraines.
• current substance use disorder (severe),
• uncontrolled manic symptoms,
• uncontrolled psychotic symptoms,
• suicidal ideation that requires hospitalization,
• if the participants endorse that English is not their first language in the screening questionnaire and demonstrate significant impairment in understanding the interviewer, they will be considered not proficient in English and will be excluded from the study.

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (13)

• Allan NP, Capron DW, Lejuez CW, Reynolds EK, MacPherson L, Schmidt NB. Developmental trajectories of anxiety symptoms in early adolescence: the influence of anxiety sensitivity. J Abnorm Child Psychol. 2014 May;42(4):589-600. doi: 10.1007/s10802-013-9806-0.

  PMID: 24062146 BACKGROUND

• Goetter EM, Frumkin MR, Palitz SA, Swee MB, Baker AW, Bui E, Simon NM. Barriers to mental health treatment among individuals with social anxiety disorder and generalized anxiety disorder. Psychol Serv. 2020 Feb;17(1):5-12. doi: 10.1037/ser0000254. Epub 2018 Aug 2.

  PMID: 30070552 BACKGROUND

• Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.

  PMID: 19646331 BACKGROUND

• Kenardy JA, Dow MG, Johnston DW, Newman MG, Thomson A, Taylor CB. A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial. J Consult Clin Psychol. 2003 Dec;71(6):1068-75. doi: 10.1037/0022-006X.71.6.1068.

  PMID: 14622082 BACKGROUND

• Keough ME, Schmidt NB. Refinement of a brief anxiety sensitivity reduction intervention. J Consult Clin Psychol. 2012 Oct;80(5):766-72. doi: 10.1037/a0027961. Epub 2012 Apr 2.

  PMID: 22468909 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

• Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.

  PMID: 22865617 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

• Newman MG, Przeworski A, Consoli AJ, Taylor CB. A randomized controlled trial of ecological momentary intervention plus brief group therapy for generalized anxiety disorder. Psychotherapy (Chic). 2014 Jun;51(2):198-206. doi: 10.1037/a0032519. Epub 2013 Sep 23.

  PMID: 24059730 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

• Schmidt NB, Eggleston AM, Woolaway-Bickel K, Fitzpatrick KK, Vasey MW, Richey JA. Anxiety Sensitivity Amelioration Training (ASAT): a longitudinal primary prevention program targeting cognitive vulnerability. J Anxiety Disord. 2007;21(3):302-19. doi: 10.1016/j.janxdis.2006.06.002. Epub 2006 Aug 4.

  PMID: 16889931 BACKGROUND

• Schmidt NB, Mitchell MA, Richey JA. Anxiety sensitivity as an incremental predictor of later anxiety symptoms and syndromes. Compr Psychiatry. 2008 Jul-Aug;49(4):407-12. doi: 10.1016/j.comppsych.2007.12.004. Epub 2008 Mar 19.

  PMID: 18555063 BACKGROUND

• Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629-40. doi: 10.1001/archpsyc.62.6.629.

  PMID: 15939840 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: During the consent process, participants are provided information that some of them may receive additional phone app intervention. This is not stressed at any other time during the study. After randomization has been completed, treatment session groups will be formed including participants from both conditions. After the the session, participants receive an email reminding them about the surveys and reminders they will be getting through the app during the upcoming 2 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Model Details: A 1.5-hour intervention session will be completed by all participants. We will ask all participants to complete homework exposure exercises. They will receive phone app reminders about completing homework. Treatment group (EMI group): For two weeks after the session, four times a day, the EMI group will receive prompts via the HIPAA-compliant EMI application (metricwire.com). The prompts will ask them about their current anxiety level. If they endorse elevated anxiety, they will be provided with a brief message reminding them about the coping skills covered during the session. They will also receive daily prompts to do exposures and enter the results in the app. Control group: The control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: July 14, 2022
• Study Start: February 9, 2022
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)