An interventional study of IntelliCare for College Students in Depression and Anxiety, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 117 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
*None
Participants will have open access to the IntelliCare system.
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
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
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
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)
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
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
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
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
| Milestone | Mobile Self-help Intervention |
|---|---|
| Started | 117 |
| Completed | 117 |
| Not completed | 0 |
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
| units on a scale | Mobile Self-help Intervention |
|---|---|
| Week 1 | 11.2 ± 15.5 |
| Week 2 | 9.5 ± 15.4 |
| Week 4 | 10.9 ± 17.5 |
| Week 6 | 9.4 ± 17.7 |
| Week 8 | 9.1 ± 15.4 |
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.
| units on a scale | Mobile Self-help Intervention |
|---|---|
| Week 1 | 10.0 ± 7.7 |
| Week 2 | 8.6 ± 10.6 |
| Week 4 | 9.0 ± 6.9 |
| Week 6 | 9.4 ± 14.2 |
| Week 8 | 10.3 ± 10.9 |
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.
| Appointments | University A | University B |
|---|---|---|
| Intake - pre-implementation | 25.4 ± 18.2 | 117.1 ± 60.7 |
| Intake - implementation | 9.7 ± 13.1 | 99.8 ± 37.4 |
| Individual therapy - pre-implementation | 224.6 ± 138.3 | 531.5 ± 166.2 |
| Individual therapy - implementation | 149.3 ± 85.1 | 442 ± 122.6 |
| Crisis - pre-implementation | 3.3 ± 2.9 | 12.8 ± 10.1 |
| Crisis - implementation | 1.7 ± 2.1 | 7 ± 4.2 |
The mean number of days the app was used was drawn from the study app over the course of the study
| days | Mobile Self-help Intervention |
|---|---|
| Average Number of Days of App Usage | 6.29 ± 11 |
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.
| units on a scale | Mobile Self-help Intervention |
|---|---|
| Baseline | 14.4 ± 3.3 |
| 1 month | 15.6 ± 4.2 |
| 2 month | 14.1 ± 5.5 |
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.
| units on a scale | Mobile Self-help Intervention |
|---|---|
| Baseline | 16.2 ± 2.9 |
| 1 month | 17.0 ± 3.5 |
| 2 month | 16.7 ± 2.9 |
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.
| score on a scale | Mobile Self-help Intervention |
|---|---|
| CB-RSS Cognitive Frequency Baseline | 9.9 ± 5.1 |
| CB-RSS Cognitive Frequency 1 month | 11.2 ± 6.4 |
| CB-RSS Cognitive Frequency 2 month | 8.02 ± 5.8 |
| CB-RSS Cognitive Usefulness Baseline | 9.5 ± 5.7 |
| CB-RSS Cognitive Usefulness 1 month | 9.7 ± 6.8 |
| CB-RSS Cognitive Usefulness 2 month | 7.3 ± 8.7 |
| CB-RSS Behavioral Frequency Baseline | 11.6 ± 4.9 |
| CB-RSS Behavioral Frequency 1 month | 11.0 ± 8.4 |
| CB-RSS Behavioral Frequency 2 month | 8.5 ± 5.4 |
| CB-RSS Behavioral Usefulness Baseline | 14.9 ± 6.8 |
| CB-RSS Behavioral Usefulness 1 month | 17.0 ± 11.0 |
| CB-RSS Behavioral Usefulness 2 month | 8.4 ± 8.6 |
Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Self-help Intervention | 0/117 (0%) | 0/117 (0%) | 0/117 (0%) |
| Age, Continuous(years) | Mobile Self-help Intervention |
|---|---|
| Mean | 24.27 ± 5.93 |
| Sex/Gender, Customized(Participants) | Mobile Self-help Intervention |
|---|---|
| Female | 96 |
| Male | 17 |
| Other | 2 |
| Declined to respond | 2 |
| Ethnicity (NIH/OMB)(Participants) | Mobile Self-help Intervention |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 92 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Mobile Self-help Intervention |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 25 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 56 |
| More than one race | 15 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | Mobile Self-help Intervention |
|---|---|
| United States | 117 |
| Patient Health Questionnaire 8 (PHQ-8) depression score(units on a scale) | Mobile Self-help Intervention |
|---|---|
| Median | 10.5 (1 to 24) |
| Generalized Anxiety Disorder - 7-item questionnaire (GAD-7) score(units on a scale) | Mobile Self-help Intervention |
|---|---|
| Median | 10 (0 to 21) |
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