Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty

August 24, 2022 updated by: Kübra Tör, Istanbul Sabahattin Zaim University

Combined Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty: A Randomized Controlled Trial

This study will examine the impact of cognitive bias modification (CBM) on perfectionism and intolerance to uncertainty. Undergraduate students will be recruited and randomly assigned to either experimental or placebo-control groups. Each group will attend four sessions of CBM over four weeks.

Study Overview

Detailed Description

Background. Cognitive bias modification (CBM) is an intervention aiming to systematically change the biases in cognitive processing using experimental paradigms. CBM was found effective with a variety of disorders and transdiagnostic variables. Although there are few studies focusing on transdiagnostic variables like perfectionism and intolerance to uncertainty, further research needs to be done for the generalizability of these results. It was aimed in this study to test the effectiveness of CBM for perfectionism and intolerance to uncertainty with a sample of undergraduate students in Turkey.

Sample size was determined using G*power for a medium to large effect size based on previous studies and it was planned to include 28 undergraduate students who have a score of >70.5 in the Brief Symptom Measure in the study. Participants will get either 3-course credits or a 100 TL bookstore gift card for their full participation. After getting informed consent from participants, they will be randomized to either active or control condition. Participants will be blind to their intervention condition. Following randomization, baseline measurements will be collected. After the baseline measures were collected, links for interventions will be e-mailed to the participants according to their assigned group. Participants will get an email including the link for the study every week. Interpretation bias scores of participants for perfectionism and intolerance to uncertainty will be collected before the first intervention session and after the last intervention session. These sessions will last approximately 25 min. Participants will attend the session without an assessment in the second and third week and these sessions will last approximately 15 min. After four sessions, post-tests will be sent to the participants. Questionnaires will also be collected one month after the intervention was done.

Study Type

Interventional

Enrollment (Actual)

54

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

    • Massachusetts
      • Lowell, Massachusetts, United States, 01854
        • University of Massachusetts Lowell

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years old
  • Have a score of >70.5 in Brief Symptom Measure
  • Being an undergraduate student
  • Fluent in Turkish
  • Access to the internet by computer

Exclusion Criteria:

  • Having any psychiatric disorder
  • Receiving a psychiatric/psychological treatment

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 Cognitive Bias Modification Group
This group of participants will receive 4 sessions of CBM targeting their interpretation biases for perfectionism and intolerance to uncertainty.
There will be four sessions of CBM. Each session will consist of two different part. The first part of the intervention will be the training based on the ambiguous scenario paradigm for perfectionism developed by Dodd (2019). Participants will need to complete word fragments in the last part of the scenario to resolve the ambiguity of the scenario. Then, a comprehension question will be presented to them to underscore the interpretation condition. Feedback will be given after each question. For the second part of the intervention aimed to intervene intolerance to uncertainty, word sentence association paradigm for intolerance to uncertainty developed by Oglesby (2017) will be used. In this intervention, participants will be asked to judge the relatedness of words and sentences which will be presented to them. Feedback will be given after each word-sentence.
Placebo Comparator: Placebo-Control Cognitive Bias Modification Group
This group of participants will receive 4 sessions of inactive CBM.
For the first part of the intervention, the control group will be presented with the same procedures as the active group; however, feedbacks will be given to resolve the scenarios in a neutral way. When it comes to the second part of the intervention, different word-sentence pairings will be presented to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Symptom Measure
Time Frame: Weeks 0, 4, 8
Psychiatric symptomatology will be assessed with Brief Symptom Measure consists of 25 items scored 1-7. Greater score means greater severity.
Weeks 0, 4, 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Interpretation bias for perfectionism
Time Frame: Weeks 0, 4
Participants will read ten scenarios and rate the relatedness of four sentences for each scenario.
Weeks 0, 4
Change in Interpretation bias for intolerance to uncertainty
Time Frame: Weeks 0, 4
Participants will judge the relatedness of word-sentence pairings. 40 pairings will be presented and each participant will have a score between 0 and 1. A score closer to 0 indicates severity of interpretation bias for intolerance to uncertainty.
Weeks 0, 4
Change in Frost Multidimensional Perfectionism Scale
Time Frame: Weeks 0, 4, 8
Self-report questionnaire of perfectionism consists of 35 items on a 5-point scale. Higher score means greater perfectionism.
Weeks 0, 4, 8
Change in Intolerance of Uncertainty Scale
Time Frame: Weeks 0, 4, 8
Self-report questionnaire of intolerance to uncertainty consists of 26 items on a 5-point scale. Higher score means greater intolerance to uncertainty.
Weeks 0, 4, 8
Change in Cognitive-Behavioral Avoidance Scale
Time Frame: Weeks 0, 4, 8
Self-report questionnaire of cognitive-behavioral avoidance consists of 31 items on a 5-point scale. Higher score means greater cognitive-behavioral avoidance.
Weeks 0, 4, 8

Collaborators and Investigators

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

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)

March 1, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 13630784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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