NCT03280472

Brief Summary

The current project will test whether a computerized training program, Cognitive Bias Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to anxiety among incoming college students. Those not in the CBM condition will complete a symptom tracking condition (ST). We will also test whether ST influences vulnerability to anxiety among incoming college students.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

August 30, 2017

Last Update Submit

December 16, 2017

Conditions

Keywords

Interpretation BiasInterpretation Modification Program

Outcome Measures

Primary Outcomes (1)

  • Change in Student Adjustment to College Questionnaire

    Self-report on the degree to which the participant feels they are transitioning to college successfully.

    Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.

Secondary Outcomes (2)

  • Change in Interpretations

    Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.

  • Change in Liebowitz Social Anxiety Scale-Self-Report

    Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.

Study Arms (2)

Cognitive Bias Modification

EXPERIMENTAL

Participants will complete three session of cognitive bias modification.

Behavioral: Cognitive Bias Modification

Symptom Tracking

OTHER

Participants will track their symptoms.

Behavioral: Symptom tracking

Interventions

CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a "Yes/No" comprehension question about the scenario. The missing letter will "resolve" the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information

Cognitive Bias Modification

Participants will track their symptoms

Symptom Tracking

Eligibility Criteria

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

You may qualify if:

  • First and Second year students
  • Entered college in fall of 2017
  • Fluent in English
  • LSAS-SR score greater than or equal to 14 and less than or equal to 74.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety Cognition and Emotion Laboratory

Oxford, Ohio, 45056, United States

RECRUITING

Study Officials

  • Elise Clerkin, PhD

    Miami University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise M Clerkin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 12, 2017

Study Start

September 18, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations