- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04843228
Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty
Combined Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Lowell, Massachusetts, United States, 01854
- University of Massachusetts Lowell
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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Placebo Comparator: Placebo-Control Cognitive Bias Modification Group
This group of participants will receive 4 sessions of inactive CBM.
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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.
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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.
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Weeks 0, 4, 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Interpretation bias for perfectionism
Time Frame: Weeks 0, 4
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Participants will read ten scenarios and rate the relatedness of four sentences for each scenario.
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Weeks 0, 4
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Change in Interpretation bias for intolerance to uncertainty
Time Frame: Weeks 0, 4
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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.
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Weeks 0, 4
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Change in Frost Multidimensional Perfectionism Scale
Time Frame: Weeks 0, 4, 8
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Self-report questionnaire of perfectionism consists of 35 items on a 5-point scale.
Higher score means greater perfectionism.
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Weeks 0, 4, 8
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Change in Intolerance of Uncertainty Scale
Time Frame: Weeks 0, 4, 8
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Self-report questionnaire of intolerance to uncertainty consists of 26 items on a 5-point scale.
Higher score means greater intolerance to uncertainty.
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Weeks 0, 4, 8
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Change in Cognitive-Behavioral Avoidance Scale
Time Frame: Weeks 0, 4, 8
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Self-report questionnaire of cognitive-behavioral avoidance consists of 31 items on a 5-point scale.
Higher score means greater cognitive-behavioral avoidance.
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Weeks 0, 4, 8
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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