Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty

Perfectionism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843228
• Other study ID #: 13630784
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2022
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intolerance to Uncertainty
• Perfectionism

Intervention

Behavioral:
• Cognitive Bias Modification
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
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.

Locations

Country	Name	City	State
United States	University of Massachusetts Lowell	Lowell	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Symptom Measure	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	Change in Interpretation bias for perfectionism	Participants will read ten scenarios and rate the relatedness of four sentences for each scenario.	Weeks 0, 4
Secondary	Change in Interpretation bias for intolerance to uncertainty	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
Secondary	Change in Frost Multidimensional Perfectionism Scale	Self-report questionnaire of perfectionism consists of 35 items on a 5-point scale. Higher score means greater perfectionism.	Weeks 0, 4, 8
Secondary	Change in Intolerance of Uncertainty Scale	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
Secondary	Change in Cognitive-Behavioral Avoidance Scale	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