Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transition to College/Miami University

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280472
Recruitment Status : Unknown
Verified December 2017 by Elise Clerkin, Miami University.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Elise Clerkin, Miami University

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.

Condition or disease Intervention/treatment Phase
Interpretation Bias Modification Symptom Tracking Behavioral: Cognitive Bias Modification Behavioral: Symptom tracking Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transition to College/Miami University
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive Bias Modification
Participants will complete three session of cognitive bias modification.
Behavioral: Cognitive Bias Modification
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

Symptom Tracking
Participants will track their symptoms.
Behavioral: Symptom tracking
Participants will track their symptoms




Primary Outcome Measures :
  1. Change in Student Adjustment to College Questionnaire [ Time Frame: 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. ]
    Self-report on the degree to which the participant feels they are transitioning to college successfully.


Secondary Outcome Measures :
  1. Change in Interpretations [ Time Frame: 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. ]
    A questionnaire assessing their interpretation of ambiguous, potentially anxiety-provoking situation

  2. Change in Liebowitz Social Anxiety Scale-Self-Report [ Time Frame: 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. ]
    Self-report of social anxiety symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280472


Contacts
Layout table for location contacts
Contact: Elise M Clerkin, PhD 513-529-2483 clerkiem@miamioh.edu

Locations
Layout table for location information
United States, Ohio
Anxiety Cognition and Emotion Laboratory Recruiting
Oxford, Ohio, United States, 45056
Contact: Elise M Clerkin, PhD    513-529-2483    cleriem@miamioh.edu   
Sponsors and Collaborators
Miami University
Investigators
Layout table for investigator information
Principal Investigator: Elise Clerkin, PhD Miami University
Layout table for additonal information
Responsible Party: Elise Clerkin, Assistant Professor, Miami University
ClinicalTrials.gov Identifier: NCT03280472    
Other Study ID Numbers: 01368r
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elise Clerkin, Miami University:
Interpretation Bias
Interpretation Modification Program