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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
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE June 27, 2014
Results First Submitted Date  ICMJE August 2, 2017
Results First Posted Date  ICMJE October 29, 2018
Last Update Posted Date October 29, 2018
Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • Changes in Depression Severity [ Time Frame: Measured at the start of treatment (baseline), week 6 and week 12. ]
    To measure changes in depression over time, the Quick Inventory of Depressive Symptomatology will be used to evaluate clinician-rated symptom severity and the Patient Health Questionnaire - 9 (PHQ9) will be used to evaluate self-reported depression.
  • Adherence to the mobile application intervention (eg - time to last use of a treatment element). [ Time Frame: Measured from start of treatment (baseline) to 12 weeks. ]
    Adherence will be assessed through use data from phone or other platforms (e.g. computer), including number of times the program was accessed, number of times each lesson, tool, and feedback element was accessed and percentage of messages viewed.
  • Changes in Anxiety [ Time Frame: Measured at the start of treatment (baseline), week 6 and week 12. ]
    To measure changes in anxiety over time, the Hamilton Anxiety Rating Scale (HAM-A) will be used to evaluate clinician-rated symptom severity and the Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to evaluate self-reported anxiety.
Change History Complete list of historical versions of study NCT02176226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
Mean Number of Treatment App Use Sessions by Study Week [ Time Frame: Weekly for Two Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Participant Satisfaction [ Time Frame: Measured at week 6 and week 12. ]
The USE questionnaire will be administered to measure satisfaction, usefulness, ease of use, and ease of learning.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
Official Title  ICMJE Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Anxiety Disorders
Intervention  ICMJE Behavioral: IntelliCare
Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
Study Arms  ICMJE Experimental: 8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks.
Intervention: Behavioral: IntelliCare
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2016)
105
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2014)
200
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02176226
Other Study ID Numbers  ICMJE R01MH100482-01FTIC( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party David Mohr, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C Mohr, Ph.D. Northwestern University
PRS Account Northwestern University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP