Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IntelliCare in College Students (ICCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035577
Recruitment Status : Active, not recruiting
First Posted : July 29, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Emily G Lattie, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Mobile self-help intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Mobile self-help intervention
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Extended usability of a mobile self-help intervention
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
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




Primary Outcome Measures :
  1. Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module [ Time Frame: Week 4 ]

    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.


  2. Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module [ Time Frame: Week 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.


  3. GAD-7 (Generalized Anxiety Disorder Scale-7) [ Time Frame: Week 4 ]
    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.

  4. GAD-7 (Generalized Anxiety Disorder Scale-7) [ Time Frame: Week 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 Outcome Measures :
  1. Mean Number of Treatment App Use Sessions by Study Week [ Time Frame: Weekly for two months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035577


Locations
Layout table for location information
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)

Layout table for additonal information
Responsible Party: Emily G Lattie, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04035577     History of Changes
Other Study ID Numbers: K08MH112878-EUT
K08MH112878 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily G Lattie, Northwestern University:
Mental health
App
Mobile phone
Stress management
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms