Intolerance of UncertaintyNCT04199884
Online Psychoeducation for Intolerance of Uncertainty
A study testing Active IU-focused Psychoeducation Intervention and Health-focused Psychoeducation Intervention in people with Intolerance of Uncertainty and Anxiety, run by Florida State University at 1 site in United States.
Trial summary
Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intolerance of Uncertainty, Anxiety
- What is being tested?
- Active IU-focused Psychoeducation Intervention and Health-focused Psychoeducation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated intolerance of uncertainty at baseline
Who cannot join
- Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32306
About this study
Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.
Read the detailed description
Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.
- Conditions
- Intolerance of Uncertainty, Anxiety
- Being tested
- Active IU-focused Psychoeducation Intervention, Health-focused Psychoeducation Intervention
- Keywords
- Intolerance of Uncertainty, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active IU-focused Psychoeducation InterventionBehavioural
This paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty.
Health-focused Psychoeducation InterventionBehavioural
This intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly.
| Study group | Role | What they receive |
|---|---|---|
| Active IU-focused Psychoeducation Intervention | Experimental | Not described Receives: Behavioral: Active IU-focused Psychoeducation Intervention |
| Health-focused Psychoeducation Intervention | Active comparator | Not described Receives: Behavioral: Health-focused Psychoeducation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intolerance of Uncertainty (IIU)
Change IU across time
Measured: Baseline to one-month follow-up
Beck Anxiety Inventory
Change in beck anxiety inventory scores across time
Measured: Baseline to one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Jul 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intolerance of UncertaintyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mary Oglesby Shapiro
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199884
- Sponsor's protocol ID
- Oglesby02
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychoeducation for Intolerance of Uncertainty
- ClinicalTrials.gov ID
- NCT04199884
- Acronym / sponsor ID
- Oglesby02
- Conditions
- Intolerance of Uncertainty, Anxiety
- Keywords
- Intolerance of Uncertainty, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Mary Oglesby Shapiro
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.
Detailed description
Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IU-focused Psychoeducation Intervention | Experimental | Behavioral: Active IU-focused Psychoeducation Intervention |
| Health-focused Psychoeducation Intervention | Active comparator | Behavioral: Health-focused Psychoeducation Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated intolerance of uncertainty at baseline
Key exclusion criteria (1 listed)
- Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active IU-focused Psychoeducation InterventionThis paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty. | Behavioural | Active IU-focused Psychoeducation Intervention |
| Health-focused Psychoeducation InterventionThis intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly. | Behavioural | Health-focused Psychoeducation Intervention |
Primary outcome
Intolerance of Uncertainty (IIU)
Time frame: Baseline to one-month follow-up
Change IU across time
Beck Anxiety Inventory
Time frame: Baseline to one-month follow-up
Change in beck anxiety inventory scores across time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Related trials for Intolerance of Uncertainty
Not yet recruiting
The Impact of a Web-based Empowerment Program on Intolerance of Uncertainty and Maintenance Burden.
Intolerance of Uncertainty, Caregiving Burden
Recruiting
Test of Target Engagement of Ambiguity Aversion
Intolerance of Uncertainty, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active IU-focused Psychoeducation Intervention and Health-focused Psychoeducation Intervention in people with Intolerance of Uncertainty and Anxiety, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intolerance of Uncertainty (IIU) (time frame: Baseline to one-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.