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Trial record 2 of 2 for:    intellicare

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02801877
First Posted: June 16, 2016
Last Update Posted: September 15, 2017
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.
Information provided by (Responsible Party):
David Mohr, Northwestern University
  Purpose
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 RCT aims to obtain information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety.

Condition Intervention
Depression Anxiety Behavioral: IntelliCare Behavioral: Hub App with the Recommender System Behavioral: Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artificial Intelligence in a Mobile (AIM) Intervention for Depression

Resource links provided by NLM:


Further study details as provided by David Mohr, Northwestern University:

Primary Outcome Measures:
  • Adherence to the mobile application intervention [ Time Frame: Participants will be followed for the duration of the 8 week trial ]
    Adherence will be defined as app usage throughout the 8 weeks.

  • Depression/Anxiety severity [ Time Frame: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6. ]
    Self-reported anxiety symptom severity and self-reported depressive symptom severity. Treatment response will be defined as change from baseline through week 8.


Secondary Outcome Measures:
  • Participant satisfaction [ Time Frame: Participants will be followed for the duration of the 8 week trial ]
    Self-reported satisfaction, usefulness, ease of use, and ease of learning measured by the USE questionnaire


Enrollment: 301
Study Start Date: July 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IntelliCare Hub recommender, coach
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
Other Name: Behavioral intervention for depression & anxiety via app
Behavioral: Hub App with the Recommender System
Other Name: Recommender via IntelliCare Hub app.
Behavioral: Coaching
Other Name: Support from coach via phone calls and messaging
Experimental: IntelliCare Hub recommender, no coach
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
Other Name: Behavioral intervention for depression & anxiety via app
Behavioral: Hub App with the Recommender System
Other Name: Recommender via IntelliCare Hub app.
Experimental: IntelliCare Hub no recommender, coach
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
Other Name: Behavioral intervention for depression & anxiety via app
Behavioral: Coaching
Other Name: Support from coach via phone calls and messaging
Experimental: IntelliCare Hub no recommender, no coach
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
Other Name: Behavioral intervention for depression & anxiety via app

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02801877


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David C Mohr, PhD Northwestern University
  More Information

Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02801877     History of Changes
Other Study ID Numbers: R01MH100482-01-RCTIC
R01MH100482-01 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2016
First Posted: June 16, 2016
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by David Mohr, Northwestern University:
Depression
Anxiety
Behavior Therapy
Technology Assisted
Mobile Phone
Cellular Phone
Smartphone
App
Coach

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders