Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K08MH112878 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile self-help intervention | Experimental | Participants will have open access to the IntelliCare system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliCare for College Students | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
*None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60642 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Weekly symptom reports at Weeks 1, 2, 4, 6 and 8 |
|
10 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Due to COVID-19-related changes and ongoing uncertainty surrounding operations on the university campuses with which we partnered, many of the program implementation plans were unable to be enacted. Due to the in-app nature of assessments, there was a high degree of data missingness on the mental health symptom data and the intervention target data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Lattie | Northwestern University | 312-503-5509 | emily.lattie@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 23, 2021 | Nov 24, 2021 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
Not provided
Not provided
Mobile self-help intervention
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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 |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Health Questionnaire 8 (PHQ-8) depression score | The PHQ-8 measures depressive symptoms on a scale from 0-24 with higher score representing higher levels of depressive symptoms | Baseline PHQ and GAD data were collected within the app, and many participants did not complete the measures | Median | Full Range | units on a scale |
|
| Generalized Anxiety Disorder - 7-item questionnaire (GAD-7) score | The GAD-7 measures anxiety symptoms on a scale from 0-21 with higher score representing higher levels of anxiety symptoms | Baseline PHQ and GAD data were collected within the app, and many participants did not complete these measures | Median | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | 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) | Appointments | Appointments |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | days | 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. | There was a substantial amount of missing data on this scale | Posted | Mean | Standard Deviation | units on a scale | 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. | There was a substantial amount of missing data on this measure | Posted | Mean | Standard Deviation | units on a scale | 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. | There was a substantial amount of missing data on this scale | Posted | Mean | Standard Deviation | score on a scale | Monthly questionnaire scores at baseline, one month and two months |
|
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
Not provided
Not provided
| D003704 |
| Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| Title | Measurements |
|---|---|
|
| Week 6 |
|
| Week 8 |
|
| Individual therapy - pre-implementation |
|
| Individual therapy - implementation |
|
| Crisis - pre-implementation |
|
| Crisis - implementation |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| CB-RSS Cognitive Usefulness Baseline |
|
| CB-RSS Cognitive Usefulness 1 month |
|
| CB-RSS Cognitive Usefulness 2 month |
|
| CB-RSS Behavioral Frequency Baseline |
|
| CB-RSS Behavioral Frequency 1 month |
|
| CB-RSS Behavioral Frequency 2 month |
|
| CB-RSS Behavioral Usefulness Baseline |
|
| CB-RSS Behavioral Usefulness 1 month |
|
| CB-RSS Behavioral Usefulness 2 month |
|