- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172427
Acceptability/Feasibility of IU Intervention (CLUE)
Acceptability/Feasibility Testing of an Intervention Targeting Intolerance of Uncertainty
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicholas Allan, Ph.D.
- Phone Number: 740-597-2717
- Email: allan@ohio.edu
Study Contact Backup
- Name: Brandon Koscinski, M.A.
- Phone Number: 315-316-7248
- Email: bk675018@ohio.edu
Study Locations
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Ohio
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Athens, Ohio, United States, 45701
- Recruiting
- Ohio University
-
Contact:
- Nicholas P Allan, Ph.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CLUE intervention (EMA + EMI)
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.
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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.
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Active Comparator: CLUE intervention (EMA only)
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.
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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.
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No Intervention: Waitlist control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Satisfaction Questionnaire-8
Time Frame: One day after 14-day EMA/EMI
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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
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One day after 14-day EMA/EMI
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Client Satisfaction Questionnaire-8
Time Frame: One month follow up
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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
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One month follow up
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Feasibility of service
Time Frame: 14-day EMA/EMI
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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
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14-day EMA/EMI
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intolerance of Uncertainty-12
Time Frame: Baseline
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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.
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Baseline
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Intolerance of Uncertainty-12
Time Frame: One day after 14-day EMA/EMI
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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.
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One day after 14-day EMA/EMI
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Intolerance of Uncertainty-12
Time Frame: One month follow up
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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.
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One month follow up
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PROMIS anxiety scale
Time Frame: Baseline
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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).
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Baseline
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PROMIS anxiety scale
Time Frame: One day after 14-day EMA/EMI
|
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).
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One day after 14-day EMA/EMI
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PROMIS anxiety scale
Time Frame: One month follow up
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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).
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One month follow up
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PROMIS depression scale
Time Frame: Baseline
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The PROMIS Depression scale measures depression.
Items are on a 5-point scale from 1 (Never) to 5 (Always).
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Baseline
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PROMIS depression scale
Time Frame: One day after 14-day EMA/EMI
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The PROMIS Depression scale measures depression.
Items are on a 5-point scale from 1 (Never) to 5 (Always).
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One day after 14-day EMA/EMI
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PROMIS depression scale
Time Frame: One month follow up
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The PROMIS Depression scale measures depression.
Items are on a 5-point scale from 1 (Never) to 5 (Always).
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One month follow up
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PROMIS stress scale
Time Frame: Baseline
|
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).
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Baseline
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PROMIS stress scale
Time Frame: One day after 14-day EMA/EMI
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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
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PROMIS stress scale
Time Frame: One month follow up
|
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).
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One month follow up
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Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: Baseline
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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.
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Baseline
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Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: One day after 14-day EMA/EMI
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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.
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One day after 14-day EMA/EMI
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Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: One month follow up
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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.
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One month follow up
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Drug Use Disorders Identification Test (DUDIT)
Time Frame: Baseline
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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.
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Baseline
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Drug Use Disorders Identification Test (DUDIT)
Time Frame: One day after 14-day EMA/EMI
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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.
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One day after 14-day EMA/EMI
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Drug Use Disorders Identification Test (DUDIT)
Time Frame: One month follow up
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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.
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One month follow up
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COVID-19 impact battery short-form (CIB-SF)
Time Frame: Baseline
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A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
|
Baseline
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COVID-19 impact battery short-form (CIB-SF)
Time Frame: One day after 14-day EMA/EMI
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A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
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One day after 14-day EMA/EMI
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COVID-19 impact battery short-form (CIB-SF)
Time Frame: One month follow up
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A five item questionnaire designed by the investigators will be used to assess COVID-19 related worries and impairment.
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One month follow up
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COVID-19 contraction questions
Time Frame: Baseline
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Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
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Baseline
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COVID-19 contraction questions
Time Frame: One day after 14-day EMA/EMI
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Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
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One day after 14-day EMA/EMI
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COVID-19 contraction questions
Time Frame: One month follow up
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Participants will be asked if they have contracted COVID-19 and how severe their symptoms were.
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One month follow up
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Insomnia Severity Index (ISI)
Time Frame: Baseline
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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.
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Baseline
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Insomnia Severity Index (ISI)
Time Frame: One day after 14-day EMA/EMI
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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.
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One day after 14-day EMA/EMI
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Insomnia Severity Index (ISI)
Time Frame: One month follow up
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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.
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One month follow up
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Penn State Worry Questionnaire (PSWQ)
Time Frame: Baseline
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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).
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Baseline
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Penn State Worry Questionnaire (PSWQ)
Time Frame: One day after 14-day EMA/EMI
|
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
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Penn State Worry Questionnaire (PSWQ)
Time Frame: One month follow up
|
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
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The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time Frame: Baseline
|
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
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The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time Frame: One day after 14-day EMA/EMI
|
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).
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One day after 14-day EMA/EMI
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The Anxiety Depression Distress Inventory-27 (ADDI-27)
Time Frame: One month follow up
|
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).
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One month follow up
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Perseverative Thought Questionnaire (PTQ)
Time Frame: Baseline
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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).
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Baseline
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Perseverative Thought Questionnaire (PTQ)
Time Frame: One day after 14-day EMA/EMI
|
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).
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One day after 14-day EMA/EMI
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Perseverative Thought Questionnaire (PTQ)
Time Frame: One month follow up
|
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).
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One month follow up
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Ruminative Response Scale (RRS)
Time Frame: Baseline
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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").
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Baseline
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Ruminative Response Scale (RRS)
Time Frame: One day after 14-day EMA/EMI
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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").
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One day after 14-day EMA/EMI
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Ruminative Response Scale (RRS)
Time Frame: One month follow up
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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").
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One month follow up
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Positive and Negative Affect Schedule-SF
Time Frame: Baseline
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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.
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Baseline
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Positive and Negative Affect Schedule-SF
Time Frame: One day after 14-day EMA/EMI
|
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.
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One day after 14-day EMA/EMI
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Positive and Negative Affect Schedule-SF
Time Frame: One month follow up
|
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.
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One month follow up
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The Metacognition Questionnaire-30 (MCQ)
Time Frame: Baseline
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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),
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Baseline
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The Metacognition Questionnaire-30 (MCQ)
Time Frame: One day after 14-day EMA/EMI
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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),
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One day after 14-day EMA/EMI
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The Metacognition Questionnaire-30 (MCQ)
Time Frame: One month follow up
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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),
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One month follow up
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Firearm ownership
Time Frame: Baseline
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Participants will be given a brief 4-item questionnaire about firearm ownership.
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Baseline
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Firearm ownership
Time Frame: One day after 14-day EMA/EMI
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Participants will be given a brief 4-item questionnaire about firearm ownership.
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One day after 14-day EMA/EMI
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Firearm ownership
Time Frame: One month follow up
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Participants will be given a brief 4-item questionnaire about firearm ownership.
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One month follow up
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Oxford Covid-19 Vaccine Hesitancy Scale
Time Frame: Baseline
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The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
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Baseline
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Oxford Covid-19 Vaccine Hesitancy Scale
Time Frame: One day after 14-day EMA/EMI
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The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
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One day after 14-day EMA/EMI
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Oxford Covid-19 Vaccine Hesitancy Scale
Time Frame: One month follow up
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The Oxford Covid-19 Vaccine Hesitancy Scale s seven-item measure that assesses hesitancy regarding the COVID-19 vaccine.
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One month follow up
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EMA questions
Time Frame: 7-day EMA period
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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.
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7-day EMA period
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EMA questions
Time Frame: 14-day EMA/EMI period
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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.
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14-day EMA/EMI period
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Tolin DF, Abramowitz JS, Brigidi BD, Foa EB. Intolerance of uncertainty in obsessive-compulsive disorder. J Anxiety Disord. 2003;17(2):233-42.
- 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.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BARLOW_CLUE intervention
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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