Acceptability/Feasibility of IU Intervention

NCT05172427 | Unknown

• 1 other identifier: BARLOW_CLUE intervention
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety disorders are prominent mental health burdens, affecting roughly 1 in 5 adults annually, and a third of individuals over the course of their life. These disorders are also impairing to individuals, with 23% of individuals with anxiety disorders describing their impairment as serious. Given the public health impact, it is crucial that interventions are designed to alleviate symptoms of anxiety, through reducing risk factors that predispose individuals to develop anxiety. One approach to do this is to develop brief interventions that could be administered virtually, which can then be supplemented using ecological momentary intervention (EMI) to reduce risk factors for anxiety disorders. In contrast to targeting more distant risk factors, targeting more direct risk factors, such as intolerance of uncertainty, could be used in the prevention and treatment of anxiety disorders.

Conditions

Generalized Anxiety Disorder; Emotional Disorder

Outcome Measures

Primary Outcomes (3)

• Client Satisfaction Questionnaire-8

  The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale

  One day after 14-day EMA/EMI

• Client Satisfaction Questionnaire-8

  The CSQ-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The CSQ-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale

  One month follow up

• Feasibility of service

  Feasibility will also be determined based on response rates for EMA/EMI. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery

  14-day EMA/EMI

Secondary Outcomes (53)

• Intolerance of Uncertainty-12

  Baseline

• Intolerance of Uncertainty-12

  One day after 14-day EMA/EMI

• Intolerance of Uncertainty-12

  One month follow up

• PROMIS anxiety scale

  Baseline

• PROMIS anxiety scale

  One day after 14-day EMA/EMI

Study Arms (3)

CLUE intervention (EMA + EMI)

ACTIVE COMPARATOR

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA, which will include EMI prompts that they come up with at the end of the CLUE intervention (framed as "key takeaways"). After the two week period of EMA/EMI, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention.

Behavioral: 14 days of EMI; Behavioral: Uncertainty reappraisal training

CLUE intervention (EMA only)

ACTIVE COMPARATOR

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, they will have a meeting with a clinician and be given the CLUE intervention targeting intolerance of uncertainty. Following this intervention, participants will be given 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline, acceptability and feasibility of the intervention will be assessed at post-intervention. One month after post-intervention, participants will complete a one-month follow up questionnaire battery, that will again ask about acceptability and feasibility of the intervention, as well as parallel questions from baseline and post-intervention.

Behavioral: Uncertainty reappraisal training

Waitlist control

NO INTERVENTION

Participants will complete baseline questionnaires, followed by seven days of baseline EMA. After seven days of baseline EMA, participants will be assigned 14 days of EMA. After the two week period of EMA, participants will complete a post-intervention questionnaires. In addition to similar questionnaires to those administered at baseline. One month after the post-intervention questionnaires, participants will complete a one-month follow up questionnaire battery, that will include parallel questions from baseline and post-intervention. As these participants did not receive the intervention following their baseline EMA, they will be given the opportunity to schedule an appointment for the intervention after they have completed their one-month follow up questionnaire.

Interventions

14 days of EMI BEHAVIORAL

Following the intervention, participants will receive personalized prompts whenever they report elevated stress or anxiety. These prompts will be generated at the end of the intervention session, and will only be sent to individuals in the EMI condition.

CLUE intervention (EMA + EMI)

Uncertainty reappraisal training BEHAVIORAL

CLUE consists of an hour long intervention, followed by a 2-week long EMI. During the hour long intervention session, participants will receive psychoeducation (i.e., defining uncertainty), discuss myths associated with uncertainty (e.g., if I do not plan things, they will go poorly), and discuss behavioral experiments that can be done to challenge uncertainty beliefs.

CLUE intervention (EMA + EMI); CLUE intervention (EMA only)

Eligibility Criteria

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

You may qualify if:

• Elevated GAD symptoms (i.e., GAD-7 scores greater than or equal to 10)
• Elevated IU symptoms (i.e., IUS-12 scores greater than or equal to 28)
• Access to a device with internet connection

You may not qualify if:

• N/A

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

Related Publications (15)

• Harvard Medical School, 2007. National Comorbidity Survey (NCS). (2017, August 21). Retrieved from https://www.hcp.med.harvard.edu/ncs/index.php. Data Table 2: 12-month prevalence DSM-IV/WMH-CIDI disorders by sex and cohort.

  BACKGROUND

• Oglesby ME, Allan NP, Schmidt NB. Randomized control trial investigating the efficacy of a computer-based intolerance of uncertainty intervention. Behav Res Ther. 2017 Aug;95:50-57. doi: 10.1016/j.brat.2017.05.007. Epub 2017 May 11.

  PMID: 28531873 BACKGROUND

• Shapiro, M. O., Allan, N. P., & Schmidt, N. B. (under review). A randomized control trial examining the efficacy of an intolerance of uncertainty focused psychoeducation intervention. 14.

  BACKGROUND

• Boswell JF, Thompson-Hollands J, Farchione TJ, Barlow DH. Intolerance of uncertainty: a common factor in the treatment of emotional disorders. J Clin Psychol. 2013 Jun;69(6):630-45. doi: 10.1002/jclp.21965. Epub 2013 Feb 4.

  PMID: 23381685 BACKGROUND

• Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.

  PMID: 16647833 BACKGROUND

• Dugas MJ, Schwartz A, Francis K. Brief Report: Intolerance of Uncertainty, Worry, and Depression. Cognit Ther Res. 2004;28(6):835-842. doi:10.1007/s10608-004-0669-0

  BACKGROUND

• Tolin DF, Abramowitz JS, Brigidi BD, Foa EB. Intolerance of uncertainty in obsessive-compulsive disorder. J Anxiety Disord. 2003;17(2):233-42. doi: 10.1016/s0887-6185(02)00182-2.

  PMID: 12614665 BACKGROUND

• McEvoy PM, Hyett MP, Shihata S, Price JE, Strachan L. The impact of methodological and measurement factors on transdiagnostic associations with intolerance of uncertainty: A meta-analysis. Clin Psychol Rev. 2019 Nov;73:101778. doi: 10.1016/j.cpr.2019.101778. Epub 2019 Oct 31.

  PMID: 31678816 BACKGROUND

• Raines AM, Oglesby ME, Walton JL, True G, Franklin CL. Intolerance of uncertainty and DSM-5 PTSD symptoms: Associations among a treatment seeking veteran sample. J Anxiety Disord. 2019 Mar;62:61-67. doi: 10.1016/j.janxdis.2018.12.002. Epub 2018 Dec 12.

  PMID: 30572246 BACKGROUND

• Zerach G, Levi-Belz Y. Intolerance of Uncertainty Moderates the Association Between Potentially Morally Injurious Events and Suicide Ideation and Behavior Among Combat Veterans. J Trauma Stress. 2019 Jun;32(3):424-436. doi: 10.1002/jts.22366. Epub 2019 Feb 5.

  PMID: 30720890 BACKGROUND

• Carleton RN. Fear of the unknown: One fear to rule them all? J Anxiety Disord. 2016 Jun;41:5-21. doi: 10.1016/j.janxdis.2016.03.011. Epub 2016 Mar 29.

  PMID: 27067453 BACKGROUND

• Garami J, Haber P, Myers CE, Allen MT, Misiak B, Frydecka D, Moustafa AA. Intolerance of uncertainty in opioid dependency - Relationship with trait anxiety and impulsivity. PLoS One. 2017 Jul 31;12(7):e0181955. doi: 10.1371/journal.pone.0181955. eCollection 2017.

  PMID: 28759635 BACKGROUND

• Grassi A, Gaggioli A, Behavior GR-C&, 2009 undefined. The green valley: the use of mobile narratives for reducing stress in commuters. liebertpub.com. https://www.liebertpub.com/doi/abs/10.1089/cpb.2008.0156?casa_token=byLouW-52ZcAAAAA:R7eHFRaJmuBay29q9Rzkhazn9jKeKZEpN_PDzWjAeM7GQRTWaSrV3M_EWPOhzsOO8S223f4JYmY. Accessed May 1, 2020.

  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

• 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

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

elastin microfibril interface located protein

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Nicholas Allan, Ph.D.

CONTACT

740-597-2717; allan@ohio.edu

Brandon Koscinski, M.A.

CONTACT

315-316-7248; bk675018@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 one of two active conditions or a waitlist control condition. Participants assigned to the EMA/EMI condition will receive the intervention, following by two weeks of EMA with personalized EMI prompts sent to them based on their responses to the EMA questions. Participants assigned to the EMA condition will receive the intervention, followed by two weeks of EMA only (with no EMI prompts based on their responses). The waitlist control will not receive the intervention prior to completing two weeks of EMA, and will not receive EMI prompts based on their responses. Those in the waitlist control will be given the opportunity to receive the intervention at their one-month follow up appointment.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: December 29, 2021
• Study Start: September 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)