N/A
N=301
IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression
Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02801877 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Adherence to the Mobile Application Intervention — 56; 56; 56; 56 days — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IntelliCare (Behavioral); Hub App with the Recommender System (Behavioral); Coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to the Mobile Application Intervention |
56; 56; 56; 56 | 0.3 |
| PRIMARY Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity |
8.87; 9.43; 8.82; 8.89; 6.58; 7.90 | 0.90 |
| PRIMARY GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity |
7.66; 8.68; 7.67; 7.80; 6.14; 7.68 | 0.53 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02801877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.