Intolerance of Uncertainty; AnxietyNCT02818296
Computerized Cognitive Bias Intervention for Intolerance of Uncertainty
A study testing Active IU CBM-I in people with Intolerance of Uncertainty; Anxiety, run by Florida State University at 1 site in United States.
Trial summary
This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology. 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 CBM-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2016
- 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 IU interpretation bias at pre-intervention.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32306
About this study
This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology.
- Conditions
- Intolerance of Uncertainty; Anxiety
- Being tested
- Active IU CBM-I, Control CBM-I
- 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 CBM-IBehavioural
Control CBM-IBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Active IU CBM-I | Experimental | This paradigm was designed to train individuals to endorse benign interpretations of ambiguous information and reject negative/threatening interpretations of ambiguous information. Participant's baseline interpretation bias was measured at baseline. Participants then underwent two training phases in which their responses were either reinforced (i.e., they were told they were correct) or punished (i.e., they were told that they were incorrect). Interpretation bias was measured again at post-training. Receives: Behavioral: Active IU CBM-I |
| Control CBM-I | Sham comparator | This paradigm was identical to the active condition except that the word/sentence pairings used were not relevant to IU and/or anxiety. Receives: Behavioral: Control CBM-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intolerance of Uncertainty Scale-Short Form
Measured: Post-Intervention (directly following the intervention during their baseline appointment) to Month 1 Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intolerance of Uncertainty; AnxietyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818296
- Sponsor's protocol ID
- Oglesby01
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Bias Intervention for Intolerance of Uncertainty
- ClinicalTrials.gov ID
- NCT02818296
- Acronym / sponsor ID
- Oglesby01
- Conditions
- Intolerance of Uncertainty; Anxiety
- Keywords
- Intolerance of uncertainty, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IU CBM-I | Experimental | Behavioral: Active IU CBM-IThis paradigm was designed to train individuals to endorse benign interpretations of ambiguous information and reject negative/threatening interpretations of ambiguous information. Participant's baseline interpretation bias was measured at baseline. Participants then underwent two training phases in which their responses were either reinforced (i.e., they were told they were correct) or punished (i.e., they were told that they were incorrect). Interpretation bias was measured again at post-training. |
| Control CBM-I | Sham comparator | Behavioral: Control CBM-IThis paradigm was identical to the active condition except that the word/sentence pairings used were not relevant to IU and/or anxiety. |
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 IU interpretation bias at pre-intervention.
Key exclusion criteria (1 listed)
- None.
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 CBM-I | Behavioural | Active IU CBM-I |
| Control CBM-I | Behavioural | Control CBM-I |
Primary outcome
Change in Intolerance of Uncertainty Scale-Short Form
Time frame: Post-Intervention (directly following the intervention during their baseline appointment) to Month 1 Follow-up
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 29 Jun 2016.
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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 CBM-I in people with Intolerance of Uncertainty; 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 29 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Change in Intolerance of Uncertainty Scale-Short Form (time frame: Post-Intervention (directly following the intervention during their baseline appointment) to Month 1 Follow-up). 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 29 Jun 2016.