Clinical trial NCT04108429: IntelliCare in College Students - Implementation (ICCS-I)
Official title: Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Mental health
App
Mobile phone
Stress management
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-30
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mobile self-help intervention
Primary purpose: SUPPORTIVE_CARE

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.

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:

\*None

Primary outcomes:
measure: Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
timeFrame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
measure: Generalized Anxiety Disorder Scale - 7 (GAD-7)
timeFrame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
measure: Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
timeFrame: 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)
measure: Average Number of Days of App Usage
timeFrame: Days of app use through study completion, up to 10 months
Secondary outcomes:
measure: Anxiety Literacy Questionnaire
timeFrame: Monthly questionnaire scores at baseline, one month and two months
measure: Depression Literacy Questionnaire
timeFrame: Monthly questionnaire scores at baseline, one month and two months
measure: Cognitive and Behavioral Response to Stress Scale (CB-RSS)
timeFrame: Monthly questionnaire scores at baseline, one month and two months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: