IntelliCare in College Students

Study Overview
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Brief Summary
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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
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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.

Official Title
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Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Mobile self-help intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Mobile self-help intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended usability of a mobile self-help intervention<br>Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks | Behavioral: Mobile self-help intervention<br>* During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe. | Week 4 | 
| Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe. | Week 8 | 
| GAD-7 (Generalized Anxiety Disorder Scale-7) | 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. | Week 4 | 
| GAD-7 (Generalized Anxiety Disorder Scale-7) | 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. | Week 8 | 
| Anxiety Literacy Questionnaire | This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., Being easily fatigued may be a symptom of anxiety disorder.) Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy. | Week 4 | 
| Anxiety Literacy Questionnaire | This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., Being easily fatigued may be a symptom of anxiety disorder.) Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy. | Week 8 | 
| Depression Literacy Questionnaire | This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., Loss of confidence and poor self-esteem may be a symptom of depression.) Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy | Week 4 | 
| Depression Literacy Questionnaire | This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., Loss of confidence and poor self-esteem may be a symptom of depression.) Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy | Week 8 | 
| Cognitive and Behavioral Response to Stress Scale | This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes. | Week 4 | 
| The Cognitive and Behavioral Response to Stress Scale | This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Treatment App Use Sessions |  | Daily for two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health, App, Mobile phone, Stress management