Transition to College/Miami University

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.

Study Overview

• Status: Unknown
• Conditions: Interpretation Bias Modification; Symptom Tracking
• Intervention / Treatment: Behavioral: Cognitive Bias Modification; Behavioral: Symptom tracking

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Oxford, Ohio, United States, 45056
      • Recruiting
      • Anxiety Cognition and Emotion Laboratory
      • Contact: Elise M Clerkin, PhD; Phone Number: 513-529-2483; Email: cleriem@miamioh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: Symptom Tracking; Participants will track their symptoms.	Behavioral: Symptom tracking; Participants will track their symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interpretations	A questionnaire assessing their interpretation of ambiguous, potentially anxiety-provoking situation	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	Self-report of social anxiety symptoms	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.

Collaborators and Investigators

• Sponsor: Miami University
• Investigators: Principal Investigator: Elise Clerkin, PhD, Miami University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: September 9, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 16, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Interpretation Modification Program; Interpretation Bias
• Other Study ID Numbers: 01368r

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No