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Completed

NCT Number: NCT04843228

Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Lowell

Lowell, Massachusetts, 01854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Bias Modification

Behavioral

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.

Cognitive Bias Modification for Control Group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Sabahattin Zaim University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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