Clinical trial NCT04035577: IntelliCare in College Students
Official title: Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
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: 2019-07-29
Enrollment: 20
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 an 8-week usability and feasibility 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 this period, research surveys assessing depression and anxiety can be completed on the app. Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.

Detailed description: In this study, students will be recruited for an 8-week trial in which they will be given the IntelliCare Hub app and encouraged to use it daily. To ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores \> 10 on either the PHQ-9 or GAD-7 and 5 without elevated scores on either measure, for a total of 20 participants. The rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants. This trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At baseline, 4 weeks, and 8 weeks, 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. At 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone. This is to gain insight on the user's experience with the app.

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 - 8 (PHQ-8) - Depression Severity Module
timeFrame: Week 4
measure: Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
timeFrame: Week 8
measure: GAD-7 (Generalized Anxiety Disorder Scale-7)
timeFrame: Week 4
measure: GAD-7 (Generalized Anxiety Disorder Scale-7)
timeFrame: Week 8
measure: Anxiety Literacy Questionnaire
timeFrame: Week 4
measure: Anxiety Literacy Questionnaire
timeFrame: Week 8
measure: Depression Literacy Questionnaire
timeFrame: Week 4
measure: Depression Literacy Questionnaire
timeFrame: Week 8
measure: Cognitive and Behavioral Response to Stress Scale
timeFrame: Week 4
measure: The Cognitive and Behavioral Response to Stress Scale
timeFrame: Week 8
Secondary outcomes:
measure: Mean Number of Treatment App Use Sessions
timeFrame: Daily for two months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: Lattie E, Cohen KA, Winquist N, Mohr DC. Examining an App-Based Mental Health Self-Care Program, IntelliCare for College Students: Single-Arm Pilot Study. JMIR Ment Health. 2020 Oct 10;7(10):e21075. doi: 10.2196/21075.