PerfectionismNCT04843228
Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty
A study testing Cognitive Bias Modification in people with Perfectionism and Intolerance to Uncertainty, run by Istanbul Sabahattin Zaim University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfectionism, Intolerance to Uncertainty
- What is being tested?
- Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having any psychiatric disorder
- Receiving a psychiatric/psychological treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Lowell
Lowell, Massachusetts, 01854
About this study
Official title: 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.
Read the 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.
- Conditions
- Perfectionism, Intolerance to Uncertainty
- Being tested
- Cognitive Bias Modification, Cognitive Bias Modification for Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Cognitive Bias Modification Group | Experimental | This group of participants will receive 4 sessions of CBM targeting their interpretation biases for perfectionism and intolerance to uncertainty. Receives: Behavioral: Cognitive Bias Modification |
| Placebo-Control Cognitive Bias Modification Group | Placebo comparator | This group of participants will receive 4 sessions of inactive CBM. Receives: Behavioral: Cognitive Bias Modification for Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 4, 8
Secondary outcomes (5)
Change in Interpretation bias for perfectionism
Participants will read ten scenarios and rate the relatedness of four sentences for each scenario.
Measured: Weeks 0, 4
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.
Measured: Weeks 0, 4
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.
Measured: Weeks 0, 4, 8
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.
Measured: Weeks 0, 4, 8
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.
Measured: Weeks 0, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Mar 2021
- Primary completion15 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfectionismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Condition 1: Cognitive Bias Modification for active group Condition 2: Cognitive Bias Modification for control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Tör, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843228
- Sponsor's protocol ID
- 13630784
- Status last verified
- Aug 2022
- First submitted
- 9 Apr 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04843228
- Acronym / sponsor ID
- 13630784
- Conditions
- Perfectionism, Intolerance to Uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Condition 1: Cognitive Bias Modification for active group Condition 2: Cognitive Bias Modification for control group
| Arm | Type | Receives |
|---|---|---|
| Active Cognitive Bias Modification Group | Experimental | Behavioral: Cognitive Bias ModificationThis group of participants will receive 4 sessions of CBM targeting their interpretation biases for perfectionism and intolerance to uncertainty. |
| Placebo-Control Cognitive Bias Modification Group | Placebo comparator | Behavioral: Cognitive Bias Modification for Control GroupThis group of participants will receive 4 sessions of inactive CBM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Having any psychiatric disorder
- Receiving a psychiatric/psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias ModificationThere 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. | Behavioural | Active Cognitive Bias Modification Group |
| Cognitive Bias Modification for Control GroupFor 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. | Behavioural | Placebo-Control Cognitive Bias Modification Group |
Primary outcome
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.
5 secondary outcomes
Change in Interpretation bias for perfectionism
Time frame: Weeks 0, 4
Change in Interpretation bias for intolerance to uncertainty
Time frame: Weeks 0, 4
Change in Frost Multidimensional Perfectionism Scale
Time frame: Weeks 0, 4, 8
Change in Intolerance of Uncertainty Scale
Time frame: Weeks 0, 4, 8
Change in Cognitive-Behavioral Avoidance Scale
Time frame: Weeks 0, 4, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Perfectionism and Intolerance to Uncertainty, run by Istanbul Sabahattin Zaim University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Symptom Measure (time frame: Weeks 0, 4, 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.