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IntelliCare in College Students - Implementation (ICCS-I)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04108429
Enrollment
117
Registered
2019-09-30
Start date
2020-02-05
Completion date
2020-12-18
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

Mental health, App, Mobile phone, Stress management

Brief 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.

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.

Interventions

BEHAVIORALIntelliCare 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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Mobile self-help intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeekly symptom reports at Weeks 1, 2, 4, 6 and 8The 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
Generalized Anxiety Disorder Scale - 7 (GAD-7)Weekly symptom reports at Weeks 1, 2, 4, 6 and 8The 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.
Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)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)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.
Average Number of Days of App UsageDays of app use through study completion, up to 10 monthsThe mean number of days the app was used was drawn from the study app over the course of the study

Secondary

MeasureTime frameDescription
Depression Literacy QuestionnaireMonthly questionnaire scores at baseline, one month and two monthsThis 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.
Cognitive and Behavioral Response to Stress Scale (CB-RSS)Monthly questionnaire scores at baseline, one month and two monthsThe 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.
Anxiety Literacy QuestionnaireMonthly questionnaire scores at baseline, one month and two monthsThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Mobile Self-help Intervention
Participants will have open access to the IntelliCare system. 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
117
Total117

Baseline characteristics

CharacteristicMobile Self-help Intervention
Age, Continuous24.27 years
STANDARD_DEVIATION 5.93
Ethnicity (NIH/OMB)
Hispanic or Latino
24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Generalized Anxiety Disorder - 7-item questionnaire (GAD-7) score10 units on a scale
Patient Health Questionnaire 8 (PHQ-8) depression score10.5 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
25 Participants
Race (NIH/OMB)
Black or African American
12 Participants
Race (NIH/OMB)
More than one race
15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
Race (NIH/OMB)
White
56 Participants
Region of Enrollment
United States
117 participants
Sex/Gender, Customized
Declined to respond
2 Participants
Sex/Gender, Customized
Female
96 Participants
Sex/Gender, Customized
Male
17 Participants
Sex/Gender, Customized
Other
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 117
other
Total, other adverse events
0 / 117
serious
Total, serious adverse events
0 / 117

Outcome results

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

Time frame: Days of app use through study completion, up to 10 months

ArmMeasureValue (MEAN)Dispersion
Mobile Self-help InterventionAverage Number of Days of App Usage6.29 daysStandard Deviation 11
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.

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)

Population: Data were collected from the counseling centers at both universities regarding how many appointments were scheduled each month from August 2018 to December 2020. For University A, August 2018 to January 2020 was labeled as the pre-implementation phase, and February 2020 to December 2020 was labeled as the implementation phase. For University B, August 2018 to July 2020 was labeled as the pre-implementation phase and August 2020 to December 2020 was labeled as the implementation phase.

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Intake - pre-implementation25.4 AppointmentsStandard Deviation 18.2
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Intake - implementation9.7 AppointmentsStandard Deviation 13.1
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Individual therapy - pre-implementation224.6 AppointmentsStandard Deviation 138.3
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Individual therapy - implementation149.3 AppointmentsStandard Deviation 85.1
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Crisis - pre-implementation3.3 AppointmentsStandard Deviation 2.9
Mobile Self-help InterventionCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Crisis - implementation1.7 AppointmentsStandard Deviation 2.1
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Crisis - pre-implementation12.8 AppointmentsStandard Deviation 10.1
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Intake - pre-implementation117.1 AppointmentsStandard Deviation 60.7
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Individual therapy - implementation442 AppointmentsStandard Deviation 122.6
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Intake - implementation99.8 AppointmentsStandard Deviation 37.4
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Crisis - implementation7 AppointmentsStandard Deviation 4.2
University BCounseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)Individual therapy - pre-implementation531.5 AppointmentsStandard Deviation 166.2
Comparison: Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).p-value: 0.275Simulation Modeling Analysis (SMA) for T
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.

Time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionGeneralized Anxiety Disorder Scale - 7 (GAD-7)Week 110.0 units on a scaleStandard Deviation 7.7
Mobile Self-help InterventionGeneralized Anxiety Disorder Scale - 7 (GAD-7)Week 28.6 units on a scaleStandard Deviation 10.6
Mobile Self-help InterventionGeneralized Anxiety Disorder Scale - 7 (GAD-7)Week 49.0 units on a scaleStandard Deviation 6.9
Mobile Self-help InterventionGeneralized Anxiety Disorder Scale - 7 (GAD-7)Week 69.4 units on a scaleStandard Deviation 14.2
Mobile Self-help InterventionGeneralized Anxiety Disorder Scale - 7 (GAD-7)Week 810.3 units on a scaleStandard Deviation 10.9
Comparison: generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8p-value: 0.759Mixed Models Analysis
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

Time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 111.2 units on a scaleStandard Deviation 15.5
Mobile Self-help InterventionPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 29.5 units on a scaleStandard Deviation 15.4
Mobile Self-help InterventionPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 410.9 units on a scaleStandard Deviation 17.5
Mobile Self-help InterventionPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 69.4 units on a scaleStandard Deviation 17.7
Mobile Self-help InterventionPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 89.1 units on a scaleStandard Deviation 15.4
Comparison: generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8p-value: 0.83Mixed Models Analysis
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.

Time frame: Monthly questionnaire scores at baseline, one month and two months

Population: There was a substantial amount of missing data on this scale

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionAnxiety Literacy QuestionnaireBaseline14.4 units on a scaleStandard Deviation 3.3
Mobile Self-help InterventionAnxiety Literacy Questionnaire1 month15.6 units on a scaleStandard Deviation 4.2
Mobile Self-help InterventionAnxiety Literacy Questionnaire2 month14.1 units on a scaleStandard Deviation 5.5
p-value: 0.002Mixed Models Analysis
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.

Time frame: Monthly questionnaire scores at baseline, one month and two months

Population: There was a substantial amount of missing data on this scale

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Frequency Baseline9.9 score on a scaleStandard Deviation 5.1
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Frequency 1 month11.2 score on a scaleStandard Deviation 6.4
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Frequency 2 month8.02 score on a scaleStandard Deviation 5.8
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Usefulness Baseline9.5 score on a scaleStandard Deviation 5.7
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Usefulness 1 month9.7 score on a scaleStandard Deviation 6.8
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Cognitive Usefulness 2 month7.3 score on a scaleStandard Deviation 8.7
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Frequency Baseline11.6 score on a scaleStandard Deviation 4.9
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Frequency 1 month11.0 score on a scaleStandard Deviation 8.4
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Frequency 2 month8.5 score on a scaleStandard Deviation 5.4
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Usefulness Baseline14.9 score on a scaleStandard Deviation 6.8
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Usefulness 1 month17.0 score on a scaleStandard Deviation 11
Mobile Self-help InterventionCognitive and Behavioral Response to Stress Scale (CB-RSS)CB-RSS Behavioral Usefulness 2 month8.4 score on a scaleStandard Deviation 8.6
Comparison: generalized linear mixed modelp-value: 0.001Mixed Models Analysis
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.

Time frame: Monthly questionnaire scores at baseline, one month and two months

Population: There was a substantial amount of missing data on this measure

ArmMeasureGroupValue (MEAN)Dispersion
Mobile Self-help InterventionDepression Literacy QuestionnaireBaseline16.2 units on a scaleStandard Deviation 2.9
Mobile Self-help InterventionDepression Literacy Questionnaire1 month17.0 units on a scaleStandard Deviation 3.5
Mobile Self-help InterventionDepression Literacy Questionnaire2 month16.7 units on a scaleStandard Deviation 2.9
Comparison: generalized linear mixed modelp-value: 0.489Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026