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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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 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.
Ohio University
Athens, Ohio, United States
RECRUITINGClient 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
Time frame: 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
Time frame: 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
Time frame: 14-day EMA/EMI
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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).
Time frame: Baseline
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).
Time frame: One day after 14-day EMA/EMI
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).
Time frame: One month follow up
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Time frame: Baseline
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Time frame: One day after 14-day EMA/EMI
PROMIS depression scale
The PROMIS Depression scale measures depression. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Time frame: One month follow up
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).
Time frame: Baseline
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).
Time frame: One day after 14-day EMA/EMI
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).
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Time frame: Baseline
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Time frame: One day after 14-day EMA/EMI
COVID-19 contraction questions
Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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).
Time frame: Baseline
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).
Time frame: One day after 14-day EMA/EMI
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).
Time frame: One month follow up
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).
Time frame: Baseline
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).
Time frame: One day after 14-day EMA/EMI
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).
Time frame: One month follow up
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).
Time frame: Baseline
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).
Time frame: One day after 14-day EMA/EMI
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).
Time frame: One month follow up
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").
Time frame: Baseline
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").
Time frame: One day after 14-day EMA/EMI
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").
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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),
Time frame: Baseline
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),
Time frame: One day after 14-day EMA/EMI
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),
Time frame: One month follow up
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Time frame: Baseline
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Time frame: One day after 14-day EMA/EMI
Firearm ownership
Participants will be given a brief 4-item questionnaire about firearm ownership.
Time frame: One month follow up
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.
Time frame: Baseline
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.
Time frame: One day after 14-day EMA/EMI
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.
Time frame: One month follow up
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.
Time frame: 7-day EMA period
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.
Time frame: 14-day EMA/EMI period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.