- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04199884
Online Psychoeducation for Intolerance of Uncertainty
December 13, 2019 updated by: Norman Schmidt, Florida State University
Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.
Study Overview
Status
Completed
Conditions
Detailed Description
Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Anxiety and Behavioral Health Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elevated intolerance of uncertainty at baseline
Exclusion Criteria:
- Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active IU-focused Psychoeducation Intervention
|
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.
|
Active Comparator: Health-focused Psychoeducation Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intolerance of Uncertainty (IIU)
Time Frame: Baseline to one-month follow-up
|
Change IU across time
|
Baseline to one-month follow-up
|
Beck Anxiety Inventory
Time Frame: Baseline to one-month follow-up
|
Change in beck anxiety inventory scores across time
|
Baseline to one-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
December 12, 2019
First Submitted That Met QC Criteria
December 13, 2019
First Posted (Actual)
December 16, 2019
Study Record Updates
Last Update Posted (Actual)
December 16, 2019
Last Update Submitted That Met QC Criteria
December 13, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Oglesby02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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