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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02176226
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Information provided by (Responsible Party):
David Mohr, Northwestern University

Brief Summary:
This study will evaluate a Smartphone intervention for depression and anxiety that uses machine learning to tailor treatment for patients. The intervention, referred to as IntelliCare, delivers patient-specific treatment material and motivational messaging via a mobile phone, to help individuals with depression and/or anxiety. Information and data received from the patient will inform the tailored treatment approach through machine learning. The purpose of this study is to obtain preliminary information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Disorders Behavioral: IntelliCare Not Applicable

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.

We are developing an intelligent treatment system 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 pilot study, 200 participants with Major Depression and/or Anxiety will use Intellicare apps for up to 8 weeks and may 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 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. Each week, participants will receive a brief motivational intervention from a coach. This coach will also be available to participants via email throughout the 8 week study. We will use data from the pilot study to examine whether IntelliCare is a feasible and effective intervention. Data collected will also be used to develop and evaluate machine learning methods which will be used in the subsequent AIM trials.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks.
Behavioral: IntelliCare
Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.

Primary Outcome Measures :
  1. Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module [ Time Frame: Baseline, Week 4, and Week 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.

  2. GAD-7 (Generalized Anxiety Disorder Scale-7) [ Time Frame: Baseline, Week 4, and 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.

Secondary Outcome Measures :
  1. Mean Number of Treatment App Use Sessions by Study Week [ Time Frame: Weekly for Two Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets criteria for clinically significant symptoms of depression or anxiety using self-report measures used in screening for depression, as well as interviewer administered measures to ensure symptoms are not transitory and have been present for at least two weeks.
  • Is familiar with the use of mobile phones
  • Has an Android phone and is willing download the IntelliCare apps on their own device
  • Is able to speak and read English
  • Is at least 19 years of age
  • Is able to give informed consent

Exclusion Criteria:

  • Has visual, hearing, voice, or motor impairment that would prevent completion of study and treatment procedures
  • Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, obsessive compulsive disorder, severe post traumatic stress disorder, etc.).
  • Exhibits severe suicidality, including ideation, plan, and intent.
  • Currently receiving psychotherapy or planning to receive psychotherapy during the 8 weeks of the study.
  • Participants who have been on an antidepressant or anxiolytic medication with no dose changes for 2 weeks and do not intend to change the dose will be eligible. Those who have been on the antidepressant or anxiolytic for less than 2 weeks or intend to have their medication optimized will be asked to wait for screening until they meet the 2-week criterion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02176226

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: David C Mohr, Ph.D. Northwestern University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University Identifier: NCT02176226    
Other Study ID Numbers: R01MH100482-01FTIC ( U.S. NIH Grant/Contract )
First Posted: June 27, 2014    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by David Mohr, Northwestern University:
Major Depressive Disorder
Anxiety Disorders
Behavior Therapy
Technology Assisted
Mobile Phone
Cellular Phone
Additional relevant MeSH terms:
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Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Mood Disorders