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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: IntelliCare
* Behavioral: Hub App with the Recommender System
* Behavioral: Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntelliCare Hub recommender, coach<br>Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program. | Behavioral: IntelliCare<br> <br> * Other names: Behavioral intervention for depression & anxiety via app;Behavioral: Hub App with the Recommender System<br> <br> * Other names: Recommender via IntelliCare Hub app.;Behavioral: Coaching<br> <br> * Other names: Support from coach via phone calls and messaging;|
| Experimental: IntelliCare Hub recommender, no coach<br>Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks. | Behavioral: IntelliCare<br> <br> * Other names: Behavioral intervention for depression & anxiety via app;Behavioral: Hub App with the Recommender System<br> <br> * Other names: Recommender via IntelliCare Hub app.;|
| Experimental: IntelliCare Hub no recommender, coach<br>Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program. | Behavioral: IntelliCare<br> <br> * Other names: Behavioral intervention for depression & anxiety via app;Behavioral: Coaching<br> <br> * Other names: Support from coach via phone calls and messaging;|
| Experimental: IntelliCare Hub no recommender, no coach<br>Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks. | Behavioral: IntelliCare<br> <br> * Other names: Behavioral intervention for depression & anxiety via app;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mobile Application Intervention | Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial | Participants will be followed for the duration of the 8 week trial | 
| 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 at start of treatment (baseline), week 4, week 8, month 3, and month 6. | 
| 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 at start of treatment (baseline), week 4, week 8, month 3, and month 6. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App, Coach