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DepressionAIMNCT02801877

IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression

A study testing IntelliCare, Hub App with the Recommender System and Coaching 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

This study will evaluate and compare a smartphone intervention for depression and anxiety that uses machine learning to tailor treatment for participants with the same intervention without the machine learning component. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety
What is being tested?
IntelliCare, Hub App with the Recommender System and Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
1 siteUnited States
Study dates
Jul 2016to Jan 2018
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets criteria for clinically significant symptoms of depression and/or anxiety using self-report measures used in screening for depression
  • Is familiar with the use of mobile phones
  • Owns an Android smartphone and is willing download the IntelliCare apps on their own device
  • Is able to speak and read English
  • Is at least 18 years of age (* Note: Depending on which state individual resides in, the age to consent to research may be 19 years of age.)
  • Is able to give informed consent

Who cannot join

  • Participants were excluded if they had visual, voice, motor or hearing impairments that would prevent participation; met diagnostic criteria for a severe psychiatric disorders for which study treatments would be inappropriate; severe suicidality that included both a plan and intent; had initiated or modified antidepressant pharmacotherapy in the previous 14 days; or had used any IntelliCare app more than one time in the three months prior to study screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Artificial Intelligence in a Mobile (AIM) Intervention for Depression

This study will evaluate and compare a smartphone intervention for depression and anxiety that uses machine learning to tailor treatment for participants with the same intervention without the machine learning component. The intervention, referred to as IntelliCare, delivers participant-specific treatment material and motivational messaging via a mobile phone to help individuals with depression and/or anxiety. Information and data received from the participant will inform the tailored treatment approach through machine learning. The purpose of this study is to compare different versions of the main IntelliCare Hub App (the centralized program delivery system) and participant user experience whether with the support of a coach or used independently. The randomized clinical trial (RCT) aims to obtain information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety.

Read the detailed description

Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the population experiencing the disorder in a given 12-month period. The relationship between depression and anxiety has been well documented. Depression is a significant predictor of future anxiety, and anxiety is a significant predictor of future onset of depression. Indeed, studies find that more than 50% of all individuals with MDD also have a current anxiety disorder. Although effective treatments have been developed over the years to address depression and anxiety, the lack of personalization and inability to adapt to patient needs or preferences contributes to poor treatment adherence and outcomes.

An intelligent treatment system was developed that uses state of the art machine learning approaches within a mobile intervention application to treat MDD and anxiety. Machine learning, a branch of artificial intelligence, focuses on the development of algorithms that automatically improve and evolve based on collected data. The intervention, called IntelliCare, uses a mobile application to continuously collect patient data and adapt intervention content and motivational messaging to create a highly tailored and user-responsive treatment system.

During the RCT study, 270 participants with Major Depression and/or Anxiety will use IntelliCare apps for up to 8 weeks and will be invited to complete online questionnaires at four follow-up time points: weeks 4 and 8 in the study program, and months 3 and 6 after the study program ends. All participants will first undergo initial assessments that will include a telephone interview and 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 lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day.

Participants will be randomly assigned to one of two versions of the IntelliCare Hub App, which is the central delivery system for the IntelliCare program, and participants will also be randomly assigned to get support from a human coach or use the IntelliCare program independently.

Each week, participants assigned to work with a coach will receive a brief motivational intervention. This coach will also be available to participants via email throughout the 8 week study. Participants randomly assigned to use the IntelliCare program independently will receive an on-boarding guide to set up the IntelliCare Hub App on their phone, and participants will have access to our tech support team if technical difficulties arise while using the program.

Data from the RCT study will be used to examine whether: the IntelliCare program is an effective intervention for reducing depressive and anxiety symptoms; the recommender system will produce greater program adherence and; support from a coach or independent use might affect user experience and adherence. Data collected will also be used to further develop and evaluate machine learning methods for future research and deployment efforts.

Conditions
Depression, Anxiety
Being tested
IntelliCare, Hub App with the Recommender System, Coaching
Keywords
Depression, Anxiety, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App, Coach
Medical subject headings
Depression, Anxiety Disorders, Alzheimer Disease

What participants receive

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

  • IntelliCareBehavioural

    Also called Behavioral intervention for depression & anxiety via app

  • Hub App with the Recommender SystemBehavioural

    Also called Recommender via IntelliCare Hub app.

  • CoachingBehavioural

    Also called Support from coach via phone calls and messaging

Study groups in NCT02801877
Study groupRoleWhat they receive
IntelliCare Hub recommender, coachExperimentalParticipant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
Receives: Behavioral: IntelliCare; Behavioral: Hub App with the Recommender System; Behavioral: Coaching
IntelliCare Hub recommender, no coachExperimentalParticipant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
Receives: Behavioral: IntelliCare; Behavioral: Hub App with the Recommender System
IntelliCare Hub no recommender, coachExperimentalParticipant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
Receives: Behavioral: IntelliCare; Behavioral: Coaching
IntelliCare Hub no recommender, no coachExperimentalParticipant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
Receives: Behavioral: IntelliCare

What is being measured

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

  1. Adherence to the Mobile Application Intervention

    Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial

    Measured: Participants will be followed for the duration of the 8 week trial

  2. Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity

    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: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.

  3. GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity

    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: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.

Timeline

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

  1. First posted16 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJan 2018
  4. Study completionJan 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02801877
Sponsor's protocol ID
R01MH100482-01-RCTIC
Other IDs
R01MH100482-01
Acronym
AIM
Status last verified
Mar 2023
First submitted
8 Jun 2016
Last updated
4 Apr 2023
Data monitoring committee
Yes
Individual data sharing
No: Interested parties may contact the PI. Data sharing may be considered if the proposed use is consistent with the protocol approved by the IRB and a Data Use Agreement is in place.

Publications

  • Mohr DC, Schueller SM, Tomasino KN, Kaiser SM, Alam N, Karr C, Vergara JL, Gray EL, Kwasny MJ, Lattie EG. Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. J Med Internet Res. 2019 Aug 28;21(8):e13609. doi: 10.2196/13609.

    PubMed 31464192

Questions about this trial

What is this clinical trial studying?

A study testing IntelliCare, Hub App with the Recommender System and Coaching 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 6 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 4 Apr 2023. 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 May 2019). 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?

Adherence to the Mobile Application Intervention (time frame: Participants will be followed for the duration of the 8 week trial). The study lists 3 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 NCT02801877, 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 4 Apr 2023.

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