IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression
AIM
Artificial Intelligence in a Mobile (AIM) Intervention for Depression
2 other identifiers
interventional
301
1 country
1
Brief Summary
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 randomized clinical trial (RCT) aims to obtain information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedResults Posted
Study results publicly available
May 31, 2019
CompletedApril 4, 2023
March 1, 2023
1.5 years
June 8, 2016
February 28, 2019
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence to the Mobile Application Intervention
Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial
Participants will be followed for the duration of the 8 week trial
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity
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.
Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.
GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity
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.
Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.
Study Arms (4)
IntelliCare Hub recommender, coach
EXPERIMENTALParticipant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare Hub recommender, no coach
EXPERIMENTALParticipant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
IntelliCare Hub no recommender, coach
EXPERIMENTALParticipant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
IntelliCare Hub no recommender, no coach
EXPERIMENTALParticipant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Meets criteria for clinically significant symptoms of depression and/or anxiety using self-report measures used in screening for depression
- Is familiar with the use of mobile phones
- Owns an Android smartphone 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
You may not qualify if:
- Participants were excluded if they had visual, voice, motor or hearing impairments that would prevent participation; met diagnostic criteria for a severe psychiatric disorders for which study treatments would be inappropriate; severe suicidality that included both a plan and intent; had initiated or modified antidepressant pharmacotherapy in the previous 14 days; or had used any IntelliCare app more than one time in the three months prior to study screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (1)
Mohr DC, Schueller SM, Tomasino KN, Kaiser SM, Alam N, Karr C, Vergara JL, Gray EL, Kwasny MJ, Lattie EG. Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. J Med Internet Res. 2019 Aug 28;21(8):e13609. doi: 10.2196/13609.
PMID: 31464192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mary Kwasny
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
David C Mohr, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 16, 2016
Study Start
July 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
April 4, 2023
Results First Posted
May 31, 2019
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
Interested parties may contact the PI. Data sharing may be considered if the proposed use is consistent with the protocol approved by the IRB and a Data Use Agreement is in place.