Study Summary
This trial is testing whether two different types of interventions can help reduce symptoms of anxiety in adults.
Eligible Conditions
- Emotional Disorder
- Generalized Anxiety Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 18 Secondary · Reporting Duration: One month follow up
14-day EMA/EMI
Feasibility of service
14-day EMA/EMI period
EMA questions
One month follow up
Alcohol Use Disorder Identification Test (AUDIT)
COVID-19 contraction questions
COVID-19 impact battery short-form (CIB-SF)
Client Satisfaction Questionnaire-8
Drug Use Disorders Identification Test (DUDIT)
Firearm ownership
Insomnia Severity Index (ISI)
Intolerance of Uncertainty-12
Oxford Covid-19 Vaccine Hesitancy Scale
PROMIS anxiety scale
PROMIS depression scale
PROMIS stress scale
Penn State Worry Questionnaire (PSWQ)
Perseverative Thought Questionnaire (PTQ)
Positive and Negative Affect Schedule-SF
Ruminative Response Scale (RRS)
The Anxiety Depression Distress Inventory-27 (ADDI-27)
The Metacognition Questionnaire-30 (MCQ)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
CLUE intervention (EMA + EMI)
1 of 3
CLUE intervention (EMA only)
1 of 3
Waitlist control
1 of 3
Active Control
45 Total Participants · 3 Treatment Groups
Primary Treatment: CLUE intervention (EMA + EMI) · No Placebo Group · N/A
CLUE intervention (EMA + EMI)ActiveComparator Group · 2 Interventions: 14 days of EMI, Uncertainty reappraisal training · Intervention Types: Behavioral, Behavioral
CLUE intervention (EMA only)
Behavioral
ActiveComparator Group · 1 Intervention: Uncertainty reappraisal training · Intervention Types: BehavioralWaitlist controlNoIntervention Group · 1 Intervention: Waitlist control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one month follow up
Who is running the clinical trial?
Ohio UniversityLead Sponsor
65 Previous Clinical Trials
36,885 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Newman, Michelle G., Amy Przeworski, Andrés J. Consoli, and C. Barr Taylor. 2014. “A Randomized Controlled Trial of Ecological Momentary Intervention Plus Brief Group Therapy for Generalized Anxiety Disorder.”. Psychotherapy. American Psychological Association (APA). doi:10.1037/a0032519.
- Carleton, R. Nicholas. 2016. “Fear of the Unknown: One Fear to Rule Them All?”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2016.03.011.
- Raines, Amanda M., Mary E. Oglesby, Jessica L. Walton, Gala True, and C. Laurel Franklin. 2019. “Intolerance of Uncertainty and DSM-5 PTSD Symptoms: Associations Among a Treatment Seeking Veteran Sample”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2018.12.002.
- Oglesby, Mary E., Nicholas P. Allan, and Norman B. Schmidt. 2017. “Randomized Control Trial Investigating the Efficacy of a Computer-based Intolerance of Uncertainty Intervention”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/j.brat.2017.05.007.
- Kenardy, Justin A., Michael G. T. Dow, Derek W. Johnston, Michelle G. Newman, Aileen Thomson, and C. Barr Taylor. 2003. “A Comparison of Delivery Methods of Cognitive-behavioral Therapy for Panic Disorder: An International Multicenter Trial.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.71.6.1068.
- McEvoy, Peter M., Matthew P. Hyett, Sarah Shihata, Jordan E. Price, and Laura Strachan. 2019. “The Impact of Methodological and Measurement Factors on Transdiagnostic Associations with Intolerance of Uncertainty: A Meta-analysis”. Clinical Psychology Review. Elsevier BV. doi:10.1016/j.cpr.2019.101778.
- Garami, Julia, Paul Haber, Catherine E. Myers, Michael T. Allen, Blazej Misiak, Dorota Frydecka, and Ahmed A. Moustafa. 2017. “Intolerance of Uncertainty in Opioid Dependency – Relationship with Trait Anxiety and Impulsivity”. Edited by Antonio Verdejo-García. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0181955.
- 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.
- Boswell, James F., Johanna Thompson-Hollands, Todd J. Farchione, and David H. Barlow. 2013. “Intolerance of Uncertainty: A Common Factor in the Treatment of Emotional Disorders”. Journal of Clinical Psychology. Wiley. doi:10.1002/jclp.21965.
- 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.
- Carleton, R. Nicholas, M.A. Peter J. Norton, and Gordon J.G. Asmundson. 2007. “Fearing the Unknown: A Short Version of the Intolerance of Uncertainty Scale”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/j.janxdis.2006.03.014.
- Tolin, David F., Jonathan S. Abramowitz, Bartholomew D. Brigidi, and Edna B. Foa. 2003. “Intolerance of Uncertainty in Obsessive-compulsive Disorder”. Journal of Anxiety Disorders. Elsevier BV. doi:10.1016/s0887-6185(02)00182-2.
- 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.
- 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
- Zerach, Gadi, and Yossi Levi‐Belz. 2019. “Intolerance of Uncertainty Moderates the Association Between Potentially Morally Injurious Events and Suicide Ideation and Behavior Among Combat Veterans”. Journal of Traumatic Stress. Wiley. doi:10.1002/jts.22366.
- 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.
- 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.
- 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.
- 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.
- 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.
- Nicholas Allan 2021. "Acceptability/Feasibility of IU Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172427.
Frequently Asked Questions
Are participants currently welcome to join this experiment?
"Affirmative. According to information provided on clinicaltrials.gov, the trial is currently enrolling patients and has been since its launch date of September 15th 2021. The last modification was made December 13th 2021 and 45 individuals are needed from a single site for participation in this medical study." - Anonymous Online Contributor
Unverified Answer
What goals are investigators attempting to accomplish with this clinical trial?
"The primary aim of the survey, which will be measured over a one-month follow up period is to evaluate service feasibility. There are also three secondary objectives that include assessing Ruminative Response Scale (RRS), Intolerance of Uncertainty-12 (IU-12), and PROMIS Anxiety scale scores. The RRS comprises queries regarding responses to depressed mood, IU-12 evaluates an individual's aptitude for tolerating ambiguous situations, while the PROMIS Anxiety scale measures fear and somatic symptoms in greater detail." - Anonymous Online Contributor
Unverified Answer
What is the current capacity for participants in this research trial?
"Affirmative. Clinicaltrials.gov verifies that the trial, which was initiated on September 15th 2021, is currently recruiting participants from a single site and needs 45 volunteers to complete it." - Anonymous Online Contributor
Unverified Answer