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
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
|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.
- 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.
- 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.
- Mean Number of Treatment App Use Sessions by Study Week [ Time Frame: Weekly for Two Months ]
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|