MedDataX Logo

The Effectiveness of Cognitive Bias Modification on Intolerance of Uncertainty

NCT ID: NCT06174311

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intolerance to Uncertainty

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Intolerance to Uncertainty Cognitive Bias Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Condition 1: Cognitive Bias Modification for active group

Condition 2: Cognitive Bias Modification for waitlist control group
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
Participants will be blinded to which condition they are assigned to. Participants will be assigned codes so that the care provider is also blinded to which condition the participants are in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Active Cognitive Bias Modification

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Izmir University of Economics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Selin Dumlu Gündoğan

Clinical Psychology Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir University of Economics

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ceren Gökdağ, Asst. Prof.

Role: CONTACT

Phone: +905542127109

Email: [email protected]

Yasemin Meral, Asst. Prof.

Role: CONTACT

Phone: +902324888580

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Selin Dumlu Gündoğan, Postgraduate

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://osf.io/xen9m/

OSF (Open Science Framework) file of the study

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CGokdag

Identifier Type: OTHER

Identifier Source: secondary_id

YMeralOgutcu

Identifier Type: OTHER

Identifier Source: secondary_id

EYuvruk

Identifier Type: OTHER

Identifier Source: secondary_id

SGundogan

Identifier Type: -

Identifier Source: org_study_id