The Effectiveness of Cognitive Bias Modification on Intolerance of Uncertainty

January 21, 2026 updated by: Selin Dumlu Gündoğan, Izmir University of Economics

The Effectiveness of Cognitive Bias Modification on Intolerance of Uncertainty: A Randomized Controlled Trial

The current study aims to reduce the intolerance of uncertainty levels with an internet-based cognitive bias modification intervention in young adults with high levels of intolerance to uncertainty aged between 18 and 40. Furthermore, it aims to examine the intervention's effectiveness on their intolerance to uncertainty, positive and negative emotions, depression and anxiety symptoms, and repetitive thinking.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intolerance of uncertainty, a common factor in mental disorders (playing a transdiagnostic role), is critical to the development and maintenance of emotional problems (e.g., depression and anxiety) as it disrupts people's daily functioning. Studies have shown that intolerance of uncertainty is closely related to psychological problems, highlighting its importance for psychological interventions. Particularly considering the transdiagnostic nature of intolerance of uncertainty, attempting to reduce this trait in individuals also provides further intervention opportunities for various problems. Therefore, reducing intolerance of uncertainty is the focus of psychotherapy studies. The cognitive-behavioral conceptualization of intolerance of uncertainty emphasizes that people are unable to tolerate uncertainty because they misinterpret ambiguous situations in a biased manner, which leads to psychological problems. Accordingly, intervening in intolerance of uncertainty involves the modification of one's biased interpretations. At this point, Cognitive bias modification (CBM) is a method that involves paradigms in which a person is exposed to a series of stimuli to alter and reduce cognitive biases related to psychopathology. In recent years, the effectiveness of CBM in different psychological problems has been proven. In addition, current studies aim to reduce psychological symptoms through the use of CBM targeting transdiagnostic features and have shown promising results. Despite the importance of intolerance of uncertainty, only one study was found in the literature that examined the effect of CBM on intolerance to uncertainty in a randomized controlled design. In that study, it was concluded that a single-session CBM was successful in reducing intolerance to uncertainty by reducing interpretation biases in individuals. However, the study has some methodological shortcomings and requires further investigation in different samples. From this point of view, the present project aims to investigate the effectiveness of CBM on intolerance of uncertainty. The proposed project will examine the effect of internet-based CBM, focusing on interpretation bias related to uncertainty, on reducing intolerance of uncertainty and general psychological symptoms using self-report and behavioral measures in a randomized controlled design. In this way, the project aims to make a scientific contribution to the relatively limited literature in this area and to reduce participants' emotional symptoms by reducing their intolerance of uncertainty.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants' willingness to participate in the CBM-I (Cognitive Bias Modification - Intervention)
  • Having high levels of intolerance of uncertainty (receiving scores higher than the median of the initial sample by splitting the data based on the median)
  • Having computer and internet access.

Exclusion Criteria:

  • Being outside the targeted age range
  • Having a psychiatric diagnosis and receiving current treatment
  • Scoring psychotic questions and suicide questions above the midpoint on the Brief Symptom Scale
  • Having color-blindness

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Cognitive Bias Modification
Based on the outcomes of pre-intervention measurements, 50 participants who score high on intolerance to uncertainty measurement will be chosen randomly to be included in this condition. This group of participants will receive three interventions targeting interpretation biases related to uncertainty, with each intervention administered at three-day intervals. Each session is scheduled to have an estimated duration of around 30 minutes.
Behavioral: Active Cognitive Bias Modification
The intervention comprises three sessions and is provided online. Each session consists of two different tasks. To prevent order effects, these tasks will be presented to each participant in a random sequence. One of the tasks involves uncertain scenarios based on a scenario paradigm. At the end of these scenarios, participants will be asked to complete a missing letter in a word that in the scenario, followed by a comprehension question related to the scenario interpretation. Following each question, feedback will be provided regarding the correctness of the response. The other task is a word-sentence pair paradigm, where participants will be asked to assess whether these pairs are related, and feedback will also be provided.
No Intervention: Control (Waitlist) Cognitive Bias Modification
The waitlist control group will not receive any interventions during the process. They will only undergo pre-test, post-test, and follow-up measurements. If they still wish to receive the intervention, it will be provided to them after the follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Intolerance of Uncertainty Scale
Time Frame: Pre-intervention and up to 4 months
The 12 items, rated on a 5-point scale (1= strongly disagree, 5= strongly agree), aim to measure individuals' intolerance of uncertainty levels. The scale provides two subscales (prospective and inhibitory) and a total score. High scores indicate a high level of intolerance of uncertainty.
Pre-intervention and up to 4 months
Change in The Beads Task
Time Frame: Pre-intervention and up to 4 months
This task is designed to behaviorally evaluate how and how quickly individuals make decisions in an uncertain situation (Huq et al., 1988; Phillips and Edwards, 1966).
Pre-intervention and up to 4 months
Change in Interpretation Bias for Intolerance of Uncertainty
Time Frame: Pre-intervention and up to 4 months
This task is used in Bias Modification for Interpretation studies to assess cognitive biases in participants before and after interventions. These tasks measure how individuals respond to stimuli similar to those they will encounter during the intervention phase, and the extent to which they make biased evaluations. The intervention in this project will consist of both a scenario task and a word-sentence association task. Therefore, in the interpretation bias task, participants' tendency to interpret uncertain scenarios and words negatively will be recorded. Participants will be presented with 10 scenarios, and they will be asked to assess the relatedness of four sentences for each scenario. Afterward, participants will be presented with 20 word-sentence pairs and expected to provide a yes or no response regarding whether they are related. The extent to which participants associate words signaling uncertainty with negative sentences will be used as a measure of interpretation bias.
Pre-intervention and up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Brief Symptom Measure
Time Frame: Pre-intervention and up to 4 months
The scale consists of 25 items, rated on a 7-point scale (1= not at all, 7= extremely). The scale aims to assess individuals' general psychopathological symptoms. Obtaining a high score on the scale indicates a high level of symptomatology.
Pre-intervention and up to 4 months
Change in Positive and Negative Affect Schedule
Time Frame: Pre-intervention and up to 4 months
The scale consists of 20 emotion expressions, half of them positive and half negative, rated on a 5-point scale (1= very little or not at all, 5= very much). Participants are asked to assess how much they have felt these 20 emotions in the past week. The scale includes 10 emotion expressions related to Positive Emotions such as excited, alert, and 10 emotion expressions related to Negative Emotions such as distressed, guilty. Scores from these subscales indicate that a high level of positive emotion suggests contentment, while a high level of negative emotion indicates discontent.
Pre-intervention and up to 4 months
Change in Repetitive Thinking Questionnaire
Time Frame: Pre-intervention and up to 4 months
The scale comprises 10 items, rated on a 5-point scale (1= not at all true, 5= very true), and it is designed to measure individuals' general repetitive thinking tendencies as a trait. The scale provides a single score, with high scores indicating a high level of repetitive thinking tendencies.
Pre-intervention and up to 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feedback Form Questionnaire
Time Frame: Post-intervention (up to 4 months)
The form includes questions for providing feedback about the intervention. In addition to the general evaluation items assessed with scales, it also incorporates open-ended questions allowing participants to provide feedback on aspects they like, dislike, and find boring, etc.
Post-intervention (up to 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir University of Economics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGundogan
  • CGokdag (Other Identifier: ManisaCelalBayarU)
  • YMeralOgutcu (Other Identifier: IzmirUEcon)
  • EYuvruk (Other Identifier: MuglaSKU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is planned to add some files to the OSF (Open Science Framework) link created for the study.

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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