Clinical trial NCT05172427: Acceptability/Feasibility of IU Intervention
Official title: Acceptability/Feasibility Testing of an Intervention Targeting Intolerance of Uncertainty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Generalized Anxiety Disorder
Emotional Disorder
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire-8
timeFrame: One day after 14-day EMA/EMI
measure: Client Satisfaction Questionnaire-8
timeFrame: One month follow up
measure: Feasibility of service
timeFrame: 14-day EMA/EMI
Secondary outcomes:
measure: Intolerance of Uncertainty-12
timeFrame: Baseline
measure: Intolerance of Uncertainty-12
timeFrame: One day after 14-day EMA/EMI
measure: Intolerance of Uncertainty-12
timeFrame: One month follow up
measure: PROMIS anxiety scale
timeFrame: Baseline
measure: PROMIS anxiety scale
timeFrame: One day after 14-day EMA/EMI
measure: PROMIS anxiety scale
timeFrame: One month follow up
measure: PROMIS depression scale
timeFrame: Baseline
measure: PROMIS depression scale
timeFrame: One day after 14-day EMA/EMI
measure: PROMIS depression scale
timeFrame: One month follow up
measure: PROMIS stress scale
timeFrame: Baseline
measure: PROMIS stress scale
timeFrame: One day after 14-day EMA/EMI
measure: PROMIS stress scale
timeFrame: One month follow up
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: One day after 14-day EMA/EMI
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: One month follow up
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: One day after 14-day EMA/EMI
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: One month follow up
measure: COVID-19 impact battery short-form (CIB-SF)
timeFrame: Baseline
measure: COVID-19 impact battery short-form (CIB-SF)
timeFrame: One day after 14-day EMA/EMI
measure: COVID-19 impact battery short-form (CIB-SF)
timeFrame: One month follow up
measure: COVID-19 contraction questions
timeFrame: Baseline
measure: COVID-19 contraction questions
timeFrame: One day after 14-day EMA/EMI
measure: COVID-19 contraction questions
timeFrame: One month follow up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: One day after 14-day EMA/EMI
measure: Insomnia Severity Index (ISI)
timeFrame: One month follow up
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: One day after 14-day EMA/EMI
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: One month follow up
measure: The Anxiety Depression Distress Inventory-27 (ADDI-27)
timeFrame: Baseline
measure: The Anxiety Depression Distress Inventory-27 (ADDI-27)
timeFrame: One day after 14-day EMA/EMI
measure: The Anxiety Depression Distress Inventory-27 (ADDI-27)
timeFrame: One month follow up
measure: Perseverative Thought Questionnaire (PTQ)
timeFrame: Baseline
measure: Perseverative Thought Questionnaire (PTQ)
timeFrame: One day after 14-day EMA/EMI
measure: Perseverative Thought Questionnaire (PTQ)
timeFrame: One month follow up
measure: Ruminative Response Scale (RRS)
timeFrame: Baseline
measure: Ruminative Response Scale (RRS)
timeFrame: One day after 14-day EMA/EMI
measure: Ruminative Response Scale (RRS)
timeFrame: One month follow up
measure: Positive and Negative Affect Schedule-SF
timeFrame: Baseline
measure: Positive and Negative Affect Schedule-SF
timeFrame: One day after 14-day EMA/EMI
measure: Positive and Negative Affect Schedule-SF
timeFrame: One month follow up
measure: The Metacognition Questionnaire-30 (MCQ)
timeFrame: Baseline
measure: The Metacognition Questionnaire-30 (MCQ)
timeFrame: One day after 14-day EMA/EMI
measure: The Metacognition Questionnaire-30 (MCQ)
timeFrame: One month follow up
measure: Firearm ownership
timeFrame: Baseline
measure: Firearm ownership
timeFrame: One day after 14-day EMA/EMI
measure: Firearm ownership
timeFrame: One month follow up
measure: Oxford Covid-19 Vaccine Hesitancy Scale
timeFrame: Baseline
measure: Oxford Covid-19 Vaccine Hesitancy Scale
timeFrame: One day after 14-day EMA/EMI
measure: Oxford Covid-19 Vaccine Hesitancy Scale
timeFrame: One month follow up
measure: EMA questions
timeFrame: 7-day EMA period
measure: EMA questions
timeFrame: 14-day EMA/EMI period
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References:
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