DepressionICCSNCT04035577
IntelliCare in College Students
A study testing Mobile self-help intervention in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
This study is an 8-week usability and feasibility 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mobile self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 5 Nov 2019
- 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.
About this study
Official title: Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
This study is an 8-week usability and feasibility 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 this period, research surveys assessing depression and anxiety can be completed on the app. Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.
Read the detailed description
In this study, students will be recruited for an 8-week trial in which they will be given the IntelliCare Hub app and encouraged to use it daily. To ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores > 10 on either the PHQ-9 or GAD-7 and 5 without elevated scores on either measure, for a total of 20 participants. The rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants. This trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At baseline, 4 weeks, and 8 weeks, 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. At 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone. This is to gain insight on the user's experience with the app.
- Conditions
- Depression, Anxiety
- Being tested
- Mobile self-help intervention
- 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.
Mobile self-help interventionBehavioural
During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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 group | Role | What they receive |
|---|---|---|
| Extended usability of a mobile self-help intervention | Experimental | Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks Receives: Behavioral: Mobile self-help intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe.
Measured: Week 4
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe.
Measured: Week 8
GAD-7 (Generalized Anxiety Disorder Scale-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: Week 4
GAD-7 (Generalized Anxiety Disorder Scale-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: Week 8
Anxiety Literacy Questionnaire
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
Measured: Week 4
Anxiety Literacy Questionnaire
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
Measured: Week 8
Depression Literacy Questionnaire
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
Measured: Week 4
Depression Literacy Questionnaire
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
Measured: Week 8
Cognitive and Behavioral Response to Stress Scale
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.
Measured: Week 4
The Cognitive and Behavioral Response to Stress Scale
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.
Measured: Week 8
Secondary outcomes (1)
Mean Number of Treatment App Use Sessions
Measured: Daily for two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start8 Jul 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Emily G Lattie, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035577
- Sponsor's protocol ID
- K08MH112878-EUT
- Other IDs
- K08MH112878
- Acronym
- ICCS
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2019
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lattie E, Cohen KA, Winquist N, Mohr DC. Examining an App-Based Mental Health Self-Care Program, IntelliCare for College Students: Single-Arm Pilot Study. JMIR Ment Health. 2020 Oct 10;7(10):e21075. doi: 10.2196/21075.
PubMed 33037874
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. 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 - Extended Usability Trial
- ClinicalTrials.gov ID
- NCT04035577
- Acronym / sponsor ID
- ICCS / K08MH112878-EUT
- Conditions
- Depression, Anxiety
- Keywords
- Mental health, App, Mobile phone, Stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an 8-week usability and feasibility 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 this period, research surveys assessing depression and anxiety can be completed on the app. Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.
Detailed description
In this study, students will be recruited for an 8-week trial in which they will be given the IntelliCare Hub app and encouraged to use it daily. To ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores > 10 on either the PHQ-9 or GAD-7 and 5 without elevated scores on either measure, for a total of 20 participants. The rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants. This trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At baseline, 4 weeks, and 8 weeks, 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. At 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone. This is to gain insight on the user's experience with the app.
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 |
|---|---|---|
| Extended usability of a mobile self-help intervention | Experimental | Behavioral: Mobile self-help interventionParticipants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks |
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 |
|---|---|---|
| Mobile self-help interventionDuring the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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 | Extended usability of a mobile self-help intervention |
Primary outcome
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Time frame: Week 4
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe.
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
Time frame: Week 8
The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe.
GAD-7 (Generalized Anxiety Disorder Scale-7)
Time frame: Week 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.
GAD-7 (Generalized Anxiety Disorder Scale-7)
Time frame: Week 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.
Anxiety Literacy Questionnaire
Time frame: Week 4
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
Anxiety Literacy Questionnaire
Time frame: Week 8
This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.
Depression Literacy Questionnaire
Time frame: Week 4
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
Depression Literacy Questionnaire
Time frame: Week 8
This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy
Cognitive and Behavioral Response to Stress Scale
Time frame: Week 4
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.
The Cognitive and Behavioral Response to Stress Scale
Time frame: Week 8
This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.
1 secondary outcome
Mean Number of Treatment App Use Sessions
Time frame: Daily for two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33037874Lattie E, Cohen KA, Winquist N, Mohr DC. Examining an App-Based Mental Health Self-Care Program, IntelliCare for College Students: Single-Arm Pilot Study. JMIR Ment Health. 2020 Oct 10;7(10):e21075. doi: 10.2196/21075.
- Individual participant dataSharing planned: Undecided
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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 Mobile self-help intervention 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 8 Oct 2020. 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 8 Oct 2020). 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 - 8 (PHQ-8) - Depression Severity Module (time frame: Week 4). The study lists 10 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 NCT04035577, which also lists 1 linked publication.
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 8 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.