N/A
N=105
IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
Major Depressive Disorder · Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02176226 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module — 12.5; 8.4; 6.4 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IntelliCare (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module |
12.5; 8.4; 6.4 | <.001 sig |
| PRIMARY GAD-7 (Generalized Anxiety Disorder Scale-7) |
10.9; 7.1; 5.8 | <.001 sig |
| SECONDARY Mean Number of Treatment App Use Sessions by Study Week |
20.09; 22.79; 24.1; 25.33; 26.07; 26.25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02176226). 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.