IntelliCare in College Students - Implementation (ICCS-I)

Depression Clinical Trial

Official title:

Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108429
• Other study ID #: K08MH112878-IET
• Secondary ID: K08MH112878
• Status: Completed
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: March 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• IntelliCare for College Students
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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module	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
Primary	Generalized Anxiety Disorder Scale - 7 (GAD-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.	Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
Primary	Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)	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.	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)
Primary	Average Number of Days of App Usage	The mean number of days the app was used was drawn from the study app over the course of the study	Days of app use through study completion, up to 10 months
Secondary	Anxiety Literacy Questionnaire	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.	Monthly questionnaire scores at baseline, one month and two months
Secondary	Depression Literacy Questionnaire	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.	Monthly questionnaire scores at baseline, one month and two months
Secondary	Cognitive and Behavioral Response to Stress Scale (CB-RSS)	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.	Monthly questionnaire scores at baseline, one month and two months