DepressionNCT04108429

IntelliCare in College Students - Implementation (ICCS-I)

A study testing IntelliCare for College Students in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Depression, Anxiety
What is being tested?: IntelliCare for College Students
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2020to 18 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60642

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Depression, Anxiety
Being tested: IntelliCare for College Students
Keywords: Mental health, App, Mobile phone, Stress management
Medical subject headings: Depression, Anxiety Disorders, Psychological Well-Being, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IntelliCare for College StudentsBehavioural
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

Study groups in NCT04108429
Study group	Role	What they receive
Mobile self-help intervention	Experimental	Participants will have open access to the IntelliCare system. Receives: Behavioral: IntelliCare for College Students

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Days of app use through study completion, up to 10 months

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: Monthly questionnaire scores at baseline, one month and two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202018 Dec 2020

First posted30 Sep 2019
Study start5 Feb 2020
Primary completion18 Dec 2020
Study completion18 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Mobile self-help intervention
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04108429
Sponsor's protocol ID: K08MH112878-IET
Other IDs: K08MH112878
Status last verified: Mar 2022
First submitted: 24 Sep 2019
Last updated: 31 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study
ClinicalTrials.gov ID: NCT04108429
Acronym / sponsor ID: K08MH112878-IET
Conditions: Depression, Anxiety
Keywords: Mental health, App, Mobile phone, Stress management
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 5 Feb 2020 (actual)
Primary completion: 18 Dec 2020 (actual)
Study completion: 18 Dec 2020 (actual)
First posted: 30 Sep 2019 (actual)
Results: Posted 31 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Mobile self-help intervention

Arm	Type	Receives
Mobile self-help intervention	Experimental	Behavioral: IntelliCare for College StudentsParticipants will have open access to the IntelliCare system.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IntelliCare for College StudentsParticipants 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	Behavioural	Mobile self-help intervention

Primary outcome

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
Generalized Anxiety Disorder Scale - 7 (GAD-7)
Time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
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.
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)
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 Usage
Time frame: Days of app use through study completion, up to 10 months
The mean number of days the app was used was drawn from the study app over the course of the study

3 secondary outcomes

Anxiety Literacy Questionnaire
Time frame: Monthly questionnaire scores at baseline, one month and two months
Depression Literacy Questionnaire
Time frame: Monthly questionnaire scores at baseline, one month and two months
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
Time frame: Monthly questionnaire scores at baseline, one month and two months

Results and safety

Results posted to the registry on 31 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Self-help Intervention	117	117

Primary outcome: Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

Time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Mobile Self-help Intervention n = 73
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)

Mobile Self-help Intervention: p = .830, Mixed Models Analysis

Primary outcome: Generalized Anxiety Disorder Scale - 7 (GAD-7)

Time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Mobile Self-help Intervention n = 73
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)

Mobile Self-help Intervention: p = .759, Mixed Models Analysis

Primary outcome: 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). Mean (Standard Deviation). Unit: Appointments

Measure	University A n = NA	University B n = NA
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)

University A vs University B: p = .275, Simulation Modeling Analysis (SMA) for T

Population analysed: 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.

Primary outcome: Average Number of Days of App Usage

Time frame: Days of app use through study completion, up to 10 months. Mean (Standard Deviation). Unit: days

Measure	Mobile Self-help Intervention n = 117
Value	6.29 (11)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Self-help Intervention	0 of 117 (0%)	0 of 117 (0%)	0 of 117

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IntelliCare for College Students in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module (time frame: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04108429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.