IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
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|ClinicalTrials.gov Identifier: NCT02176226|
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Anxiety Disorders||Behavioral: IntelliCare||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks.
Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
- Adherence to the mobile application intervention (eg - time to last use of a treatment element). [ Time Frame: Participants will be followed for the duration of the 8 week trial ]Adherence will be assessed through use data from phone or other platform
- Participant Satisfaction [ Time Frame: Participants will be followed for the duration of the 8 week trial ]Self-reported satisfaction
- Changes in Anxiety [ Time Frame: Participants will be followed for the duration of the 8 week trial ]Self-reported anxiety symptom severity
- Changes in Depression Severity [ Time Frame: Participants will be followed for the duration of the 8 week trial ]Self-reported depressive symptom severity
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): NCT02176226
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||David C Mohr, Ph.D.||Northwestern University|