NCT06174311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 8, 2023

Last Update Submit

January 21, 2026

Conditions

Keywords

Intolerance to UncertaintyCognitive Bias Modification

Outcome Measures

Primary Outcomes (3)

  • Change in Intolerance of Uncertainty Scale

    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

    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

    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 Outcomes (3)

  • Change in Brief Symptom Measure

    Pre-intervention and up to 4 months

  • Change in Positive and Negative Affect Schedule

    Pre-intervention and up to 4 months

  • Change in Repetitive Thinking Questionnaire

    Pre-intervention and up to 4 months

Other Outcomes (1)

  • Feedback Form Questionnaire

    Post-intervention (up to 4 months)

Study Arms (2)

Active Cognitive Bias Modification

EXPERIMENTAL

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

Control (Waitlist) Cognitive Bias Modification

NO INTERVENTION

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.

Interventions

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.

Active Cognitive Bias Modification

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, Turkey (Türkiye)

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Condition 1: Cognitive Bias Modification for active group Condition 2: Cognitive Bias Modification for waitlist control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology Graduate Student

Study Record Dates

First Submitted

December 8, 2023

First Posted

December 18, 2023

Study Start

November 23, 2023

Primary Completion

March 20, 2024

Study Completion

June 20, 2024

Last Updated

January 23, 2026

Record last verified: 2026-01

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