- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108429
IntelliCare in College Students - Implementation (ICCS-I)
March 8, 2022 updated by: Emily G Lattie, Northwestern University
Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60642
- Northwestern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile self-help intervention
Participants will have open access to the IntelliCare system.
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Participants will receive 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Time Frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
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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.
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Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
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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)
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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.
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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)
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Average Number of Days of App Usage
Time Frame: Days of app use through study completion, up to 10 months
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The mean number of days the app was used was drawn from the study app over the course of the study
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Days of app use through study completion, up to 10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety Literacy Questionnaire
Time Frame: Monthly questionnaire scores at baseline, one month and two months
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This is a measure of mental health literacy, specifically about symptoms of anxiety.
Participants respond "True" or "False" to statements about anxiety and the correct responses are tallied to create total score.
The range of score is range of scores is 0-22 with higher scores indicating greater literacy.
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Monthly questionnaire scores at baseline, one month and two months
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Depression Literacy Questionnaire
Time Frame: Monthly questionnaire scores at baseline, one month and two months
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This is a measure of mental health literacy, specifically about symptoms of depression.
Participants respond "True" or "False" to statements about depression and the correct responses are tallied to create total score.
The range of scores is 0-22 with higher scores indicating greater literacy.
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Monthly questionnaire scores at baseline, one month and two months
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Cognitive and Behavioral Response to Stress Scale (CB-RSS)
Time Frame: Monthly questionnaire scores at baseline, one month and two months
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The CB-RSS is a 9 item measure of the frequency and perceived helpfulness of cognitive and behavioral coping skills.
There are 4 subscales representing "Cognitive frequency" "Cognitive helpfulness" "Behavioral frequency" and "Behavioral helpfulness."
Participants respond to the frequency items on a scale of 0 = Never to 6 = Always and to the helpfulness items on a scale of 0 = Not at all helpful to 6 = Extremely helpful.
The scores range from 0-24 on the Cognitive subscales and from 0-30 on the Behavioral subscales.
Higher values represent a better outcome.
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Monthly questionnaire scores at baseline, one month and two months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2020
Primary Completion (Actual)
December 18, 2020
Study Completion (Actual)
December 18, 2020
Study Registration Dates
First Submitted
September 24, 2019
First Submitted That Met QC Criteria
September 26, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K08MH112878-IET
- K08MH112878 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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