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Clinical Trials/NCT04108429
NCT04108429
Completed
Not Applicable

Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study

Northwestern University1 site in 1 country117 target enrollmentFebruary 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Northwestern University
Enrollment
117
Locations
1
Primary Endpoint
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study is a hybrid effectiveness-implementation trial of the smartphone student stress-management app IntelliCare for college students. This intervention will be tested with University of Illinois at Chicago (UIC) and Northern Illinois University (NIU) students. During the study, participants will complete measures of depressive and anxious symptoms, as well as measures of mental health literacy, within the app.

Detailed Description

In this study, students will be recruited to use the IntelliCare Hub app and encouraged to use it daily.The overall aim of this study is to pilot the program, evaluation metrics, implementation strategies, data collection and assessment procedures for a larger implementation trial. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At monthly intervals, participants will be prompted within the app to complete the Depression Literacy Questionnaire and Anxiety Literacy Questionnaire to measure mental health literacy, the Knowledge and Beliefs about Services scale to measure knowledge of campus mental health services, the Barriers to Mental Health Help-Seeking questionnaire to measure treatment barriers, and the Cognitive and Behavioral Response to Stress Scale to measure cognitive and behavioral coping skills. Counseling center utilization data will be extracted from the participating counseling centers' electronic medical records.

Registry
clinicaltrials.gov
Start Date
February 5, 2020
End Date
December 18, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily G Lattie

Assistant Professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Participant is a student at the University of Illinois in Chicago or Northern Illinois University. \*Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
  • Participant is 18 years of age or older

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

Time Frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe

Average Number of Days of App Usage

Time Frame: Days of app use through study completion, up to 10 months

The mean number of days the app was used was drawn from the study app over the course of the study

Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)

Time Frame: Biweekly session utilization from August 1, 2018 (start of pre-implementation data collection; prior to the implementation trial) to December 18, 2020 (end of implementation period)

Counseling session utilization data were examined on a biweekly basis to determine if the introduction of the IntelliCare for College Students program impacts counseling center utilization. Counts of types of sessions (e.g. intake appointments, individual counseling appointments, crisis appointments) attended by students were examined over time to look at potential changes. These data were collected from the university in aggregate, thus, there are not participant-level data.

Generalized Anxiety Disorder Scale - 7 (GAD-7)

Time Frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.

Secondary Outcomes

  • Depression Literacy Questionnaire(Monthly questionnaire scores at baseline, one month and two months)
  • Anxiety Literacy Questionnaire(Monthly questionnaire scores at baseline, one month and two months)
  • Cognitive and Behavioral Response to Stress Scale (CB-RSS)(Monthly questionnaire scores at baseline, one month and two months)

Study Sites (1)

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