Acceptability/Feasibility of IU Intervention

Generalized Anxiety Disorder Clinical Trial

— CLUE  

Official title:

Acceptability/Feasibility Testing of an Intervention Targeting Intolerance of Uncertainty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172427
• Other study ID #: BARLOW_CLUE intervention
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Ohio University
• Contact: Nicholas Allan, Ph.D.
• Phone: 740-597-2717
• Email: allan[@]ohio.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Anxiety disorders have been estimated to impact roughly 1 in 5 (19%) adults in the United States over the past year, and almost a third (31%) of adults in the United States over the course of their life. Further, these disorders are impairing to individuals; 23% of individuals with anxiety disorders describing their impairment as serious. Given this public health impact, it is crucial, that interventions are designed to alleviate symptoms of anxiety, or to reduce risk factors that may predispose individuals to develop anxiety. Further, it is expected that the COVID-19 will have long-lasting impacts on mental concerns worldwide. With these concerns come new opportunities to improve mental health care, through ultra-brief, self-paced, web-based interventions. These interventions are ideal to increase access to care given their high dissemination value and low cost. Building on prior experimental and intervention work conducted by Dr. Allan, we aim to conduct pilot testing of an ultra-brief, CBT-informed intervention targeting intolerance of uncertainty, or an extreme aversion to and fear of uncertainty.

Intolerance of uncertainty is an ideal construct to target in a broad web-based intervention given theoretical and empirical links between intolerance of uncertainty and a broad spectrum of anxiety and related disorders. Theoretically, intolerance of uncertainty amplifies the experience of stress and anxiety causing people to engage in maladaptive cognitive (e.g., worry) and behavioral (e.g., checking, avoidance) strategies to reduce distress, preventing an opportunity to habituate to the uncertainty. Empirically, a recent meta-analysis reported effect sizes (ds) ranging from .4 to .6 across generalized anxiety disorder, major depression, obsessive compulsive disorder, social anxiety disorder, panic disorder and agoraphobia, and eating disorders. Other studies have implicated intolerance of uncertainty in posttraumatic stress disorder as well as suicidal thought and behavior. More recent evidence has demonstrated that intolerance of uncertainty is not only a "fundamental fear" underlying anxiety disorder etiology but has also been implicated in a host of other mental health problems, including substance use. We recently examined the impact of intolerance of uncertainty on anxiety and depression during the COVID-19 pandemic over three months and found intolerance of uncertainty was concurrently associated with and significantly predictive of symptoms of generalized anxiety disorder and depression. Therefore, not only is there strong theoretical and empirical support for intolerance of uncertainty as a transdiagnostic risk factor for anxiety and related conditions, but there is also evidence that supports intolerance of uncertainty as particularly relevant to the current environmental conditions due to COVID-19.

To date, we have conducted the only pilot RCT of a CBT-based intervention (clinicaltrials.gov NCT04199884). In a sample of 84 participants with elevated intolerance of uncertainty during their screening appointment, we compared a researcher-facilitated Intolerance of Uncertainty Treatment (IUT) to a time-matched healthy living control condition. IUT contains psychoeducation, challenging negative automatic thoughts regarding uncertainty through "mythbusting" exercises, and designing behavioral experiments to challenge these negative automatic thoughts. In this study, significant, medium effect size differences (d = .46) emerged between IUT and the control condition, but not until the month 1 follow-up. In addition, reductions in intolerance of uncertainty served as indirect effects from treatment condition to anxiety and depression symptoms. Further, most people found the intervention easy to understand, helpful, and applicable to their daily lives. Building on this prior work, we plan to adapt the existing ultra-brief intolerance of uncertainty intervention to be disseminated via a web-based computerized platform. Given the flexibility afforded via this digital platform, we also propose to include ecological momentary intervention (EMI) to enhance learning through the application of critical interventions skills as needed. EMI is ideal for these brief interventions as it allows for participants to gain the much-needed practice of challenging negative automatic thoughts and completing behavioral experiments critical to internalizing the skills and strategies taught during the intervention. Similar augmentations to brief interventions for stress, generalized anxiety disorder, and panic disorder (d = .5) have been successful in enhancing intervention effects (i.e., an additional d of .4 to .6), further underscoring the promise of including EMI to optimize outcomes.

The goals specific to this project are to 1) engage stakeholders in the design of an ultra-brief intolerance of uncertainty intervention (Enhanced Intolerance of Uncertainty Treatment [E-IUT]) and 2) to conduct a pilot trial to evaluate the acceptability, feasibility, and preliminary effect size estimates of E-IUT, in support of a larger fully powered test of E-IUT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Emotional Disorder
• Generalized Anxiety Disorder

Intervention

Behavioral:
• 14 days of EMI
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.
• Uncertainty reappraisal training
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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. Epub 2006 May 2. — View Citation

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. Review. — View Citation

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

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. — View Citation

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.

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.

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Tolin DF, Abramowitz JS, Brigidi BD, Foa EB. Intolerance of uncertainty in obsessive-compulsive disorder. J Anxiety Disord. 2003;17(2):233-42. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Intolerance of Uncertainty-12	a 12-item scale for measuring trait IU. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future.	Baseline
Secondary	Intolerance of Uncertainty-12	a 12-item scale for measuring trait IU. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future.	One day after 14-day EMA/EMI
Secondary	Intolerance of Uncertainty-12	a 12-item scale for measuring trait IU. it is used for assessing the degree to which individuals are able to tolerate the uncertainty of ambiguous situations, the cognitive and behavioral responses to uncertainty, perceived implications of uncertainty, and attempts to control the future.	One month follow up
Secondary	PROMIS anxiety scale	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
Secondary	PROMIS anxiety scale	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).	One day after 14-day EMA/EMI
Secondary	PROMIS anxiety scale	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).	One month follow up
Secondary	PROMIS depression scale	The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).	Baseline
Secondary	PROMIS depression scale	The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).	One day after 14-day EMA/EMI
Secondary	PROMIS depression scale	The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).	One month follow up
Secondary	PROMIS stress scale	The PROMIS Psychological Stress scale measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always).	Baseline
Secondary	PROMIS stress scale	The PROMIS Psychological Stress scale measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always).	One day after 14-day EMA/EMI
Secondary	PROMIS stress scale	The PROMIS Psychological Stress scale measures feelings about self and the world in the context of challenges. Items are on a 5-point scale from 1 (Never) to 5 (Always).	One month follow up
Secondary	Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior.	Baseline
Secondary	Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior.	One day after 14-day EMA/EMI
Secondary	Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item questionnaire that assesses alcohol consumption, drinking behavior, and alcohol-related problems. The AUDIT will be administered to assess drinking behavior.	One month follow up
Secondary	Drug Use Disorders Identification Test (DUDIT)	The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior.	Baseline
Secondary	Drug Use Disorders Identification Test (DUDIT)	The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior.	One day after 14-day EMA/EMI
Secondary	Drug Use Disorders Identification Test (DUDIT)	The DUDIT is an 11-item questionnaire that assesses drug consumption, drug use behavior, and drug-related problems. The DUDIT will be administered to assess drug use behavior.	One month follow up
Secondary	COVID-19 impact battery short-form (CIB-SF)	A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.	Baseline
Secondary	COVID-19 impact battery short-form (CIB-SF)	A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.	One day after 14-day EMA/EMI
Secondary	COVID-19 impact battery short-form (CIB-SF)	A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.	One month follow up
Secondary	COVID-19 contraction questions	Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.	Baseline
Secondary	COVID-19 contraction questions	Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.	One day after 14-day EMA/EMI
Secondary	COVID-19 contraction questions	Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.	One month follow up
Secondary	Insomnia Severity Index (ISI)	The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.	Baseline
Secondary	Insomnia Severity Index (ISI)	The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.	One day after 14-day EMA/EMI
Secondary	Insomnia Severity Index (ISI)	The ISI is a seven-item self-report questionnaire designed to assess sleep difficulties (i.e., falling asleep, staying asleep, waking too early), satisfaction/dissatisfaction with sleep patterns, and/or interference with daily functioning. Participants will be asked to rate each item using a five-point Likert-type scale ranging from zero to four, with higher scores reflecting more severe sleep problems and greater dissatisfaction with sleep.	One month follow up
Secondary	Penn State Worry Questionnaire (PSWQ)	The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).	Baseline
Secondary	Penn State Worry Questionnaire (PSWQ)	The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).	One day after 14-day EMA/EMI
Secondary	Penn State Worry Questionnaire (PSWQ)	The PSWQ is a 16-item measure used to measure the trait of worry. The process of worry is pervasive throughout all of the anxiety disorders (Barlow, 1988). The questionnaire correlates with many psychological measures related to worry and does not correlate with other measures more remote to the construct. Items are measured on a 5-point Likert-type scale ranging from Not at all typical of me (1) to Very typical of me (5).	One month follow up
Secondary	The Anxiety Depression Distress Inventory-27 (ADDI-27)	The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).	Baseline
Secondary	The Anxiety Depression Distress Inventory-27 (ADDI-27)	The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).	One day after 14-day EMA/EMI
Secondary	The Anxiety Depression Distress Inventory-27 (ADDI-27)	The ADDI-27 is a 27-item questionnaire that contains three empirically derived scales (Positive Affect, Somatic Anxiety, and General Distress), which are relevant dimensions of the tripartite model of affect. Items are measured on a 5-point Likert-type scale ranging from Not at all (1) to Extremely (5).	One month follow up
Secondary	Perseverative Thought Questionnaire (PTQ)	The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).	Baseline
Secondary	Perseverative Thought Questionnaire (PTQ)	The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).	One day after 14-day EMA/EMI
Secondary	Perseverative Thought Questionnaire (PTQ)	The PTQ is a 15-item measure of repetitive negative thinking (RNT). Perseverative thinking is repetitive, negative thoughts that persist intrusive to the point of being unproductive to the individual. The thought process and the individual seeing the thoughts as dysfunctional can also characterize this thinking. Items are measured on a 5-point Likert-type scale of Never (0) to Almost Always (4).	One month follow up
Secondary	Ruminative Response Scale (RRS)	The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").	Baseline
Secondary	Ruminative Response Scale (RRS)	The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").	One day after 14-day EMA/EMI
Secondary	Ruminative Response Scale (RRS)	The RRS includes 22 items describing responses to depressed mood that are focused on self (e.g., "I think back to other times I have been depressed"), focused on symptoms (e.g., "I think about how hard it is to concentrate"), or focused on the possible consequences and causes of their mood (e.g., "I go away by myself and think about why I feel this way").	One month follow up
Secondary	Positive and Negative Affect Schedule-SF	The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.	Baseline
Secondary	Positive and Negative Affect Schedule-SF	The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.	One day after 14-day EMA/EMI
Secondary	Positive and Negative Affect Schedule-SF	The PANAS SF scales with two higher order factors: positive affect and negative affect. The PANAS-SF consists of 20 words that describe different feelings and emotions. Participants will be asked to rate on a 5-point Likert-type scale of Very slightly or not at all (1) to Extremely (5) for the degree in which they feel each word.	One month follow up
Secondary	The Metacognition Questionnaire-30 (MCQ)	The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),	Baseline
Secondary	The Metacognition Questionnaire-30 (MCQ)	The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),	One day after 14-day EMA/EMI
Secondary	The Metacognition Questionnaire-30 (MCQ)	The MCQ s a 30-item self-report scale measuring beliefs about thinking (i.e., metacognitive beliefs), monitoring tendencies, and judgements considered to be the etiological basis of anxiety and depression within the metacognitive model of psychopathology. Each item is scored on a four-point Likert response scale ranging from 1 (do not agree) to 4 (agree very much),	One month follow up
Secondary	Firearm ownership	Participants will be given a brief 4-item questionnaire about firearm ownership.	Baseline
Secondary	Firearm ownership	Participants will be given a brief 4-item questionnaire about firearm ownership.	One day after 14-day EMA/EMI
Secondary	Firearm ownership	Participants will be given a brief 4-item questionnaire about firearm ownership.	One month follow up
Secondary	Oxford Covid-19 Vaccine Hesitancy Scale	The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.	Baseline
Secondary	Oxford Covid-19 Vaccine Hesitancy Scale	The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.	One day after 14-day EMA/EMI
Secondary	Oxford Covid-19 Vaccine Hesitancy Scale	The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.	One month follow up
Secondary	EMA questions	EMA questions will be given 4 times per day in a 12 hour period. The first survey ("Morning survey") will be a survey that takes approximately 3 minutes to complete. The following surveys ("afternoon surveys") will take approximately a minute to complete. In the 14 day EMA/EMI period, those in the CLUE + EMI condition will receive intervention prompts based on their responses. For those in the CLUE and waitlist control condition, they will not receive intervention prompts based on their responses.	7-day EMA period
Secondary	EMA questions	EMA questions will be given 4 times per day in a 12 hour period. The first survey ("Morning survey") will be a survey that takes approximately 3 minutes to complete. The following surveys ("afternoon surveys") will take approximately a minute to complete. In the 14 day EMA/EMI period, those in the CLUE + EMI condition will receive intervention prompts based on their responses. For those in the CLUE and waitlist control condition, they will not receive intervention prompts based on their responses.	14-day EMA/EMI period