NCT04843228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

April 9, 2021

Last Update Submit

August 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Interpretation bias for perfectionism

    Weeks 0, 4

  • Change in Interpretation bias for intolerance to uncertainty

    Weeks 0, 4

  • Change in Frost Multidimensional Perfectionism Scale

    Weeks 0, 4, 8

  • Change in Intolerance of Uncertainty Scale

    Weeks 0, 4, 8

  • Change in Cognitive-Behavioral Avoidance Scale

    Weeks 0, 4, 8

Study Arms (2)

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.

Behavioral: Cognitive Bias Modification

Placebo-Control Cognitive Bias Modification Group

PLACEBO COMPARATOR

This group of participants will receive 4 sessions of inactive CBM.

Behavioral: Cognitive Bias Modification for Control Group

Interventions

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.

Active Cognitive Bias Modification 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.

Placebo-Control Cognitive Bias Modification Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Lowell

Lowell, Massachusetts, 01854, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants will be blinded to their assigned condition. They will have ID numbers created by random.org which will allow the care provider to be blinded to the assigned conditions of participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Condition 1: Cognitive Bias Modification for active group Condition 2: Cognitive Bias Modification for control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MA

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 13, 2021

Study Start

March 1, 2021

Primary Completion

June 15, 2021

Study Completion

July 15, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations