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IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression

Artificial Intelligence in a Mobile (AIM) Intervention for Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02801877
Acronym
AIM
Enrollment
301
Registered
2016-06-16
Start date
2016-07-31
Completion date
2018-01-31
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

Depression, Anxiety, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App, Coach

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.

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. An intelligent treatment system was developed 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 RCT study, 270 participants with Major Depression and/or Anxiety will use IntelliCare apps for up to 8 weeks and will be invited to complete online questionnaires at four follow-up time points: weeks 4 and 8 in the study program, and months 3 and 6 after the study program ends. 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. Participants will be randomly assigned to one of two versions of the IntelliCare Hub App, which is the central delivery system for the IntelliCare program, and participants will also be randomly assigned to get support from a human coach or use the IntelliCare program independently. Each week, participants assigned to work with a coach will receive a brief motivational intervention. This coach will also be available to participants via email throughout the 8 week study. Participants randomly assigned to use the IntelliCare program independently will receive an on-boarding guide to set up the IntelliCare Hub App on their phone, and participants will have access to our tech support team if technical difficulties arise while using the program. Data from the RCT study will be used to examine whether: the IntelliCare program is an effective intervention for reducing depressive and anxiety symptoms; the recommender system will produce greater program adherence and; support from a coach or independent use might affect user experience and adherence. Data collected will also be used to further develop and evaluate machine learning methods for future research and deployment efforts.

Interventions

BEHAVIORALIntelliCare
BEHAVIORALHub App with the Recommender System
BEHAVIORALCoaching

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to the Mobile Application InterventionParticipants will be followed for the duration of the 8 week trialDefined as the median time to last engagement with the mobile application suite within 8 weeks of trial
Patient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMeasured at start of treatment (baseline), week 4, week 8, month 3, and month 6.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) - Anxiety SeverityMeasured at start of treatment (baseline), week 4, week 8, month 3, and month 6.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
IntelliCare Hub Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program. IntelliCare Hub App with the Recommender System Coaching
74
IntelliCare Hub Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks. IntelliCare Hub App with the Recommender System
75
IntelliCare Hub no Recommender, Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program. IntelliCare Coaching
76
IntelliCare Hub no Recommender, no Coach
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks. IntelliCare
76
Total301

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up1120
Overall StudyNever Started Treatment2040

Baseline characteristics

CharacteristicIntelliCare Hub Recommender, CoachIntelliCare Hub Recommender, no CoachIntelliCare Hub no Recommender, CoachIntelliCare Hub no Recommender, no CoachTotal
Age, Continuous37.6 years
STANDARD_DEVIATION 12.2
36.2 years
STANDARD_DEVIATION 11.5
37.1 years
STANDARD_DEVIATION 12.3
35.3 years
STANDARD_DEVIATION 11.5
36.5 years
STANDARD_DEVIATION 11.8
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants8 Participants7 Participants5 Participants30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
62 Participants67 Participants68 Participants71 Participants268 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants0 Participants3 Participants
Generalized Anxiety Disorder 7 (GAD-7)11.86 units on a scale
STANDARD_DEVIATION 4.05
11.88 units on a scale
STANDARD_DEVIATION 3.85
12.33 units on a scale
STANDARD_DEVIATION 4.51
11.84 units on a scale
STANDARD_DEVIATION 3.66
11.98 units on a scale
STANDARD_DEVIATION 4.02
Patient Health Questionaire 9 (PHQ-9)12.78 units on a scale
STANDARD_DEVIATION 4.45
13.24 units on a scale
STANDARD_DEVIATION 4.55
13.11 units on a scale
STANDARD_DEVIATION 4.75
13.70 units on a scale
STANDARD_DEVIATION 4.79
13.21 units on a scale
STANDARD_DEVIATION 4.63
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants5 Participants2 Participants10 Participants
Race (NIH/OMB)
Black or African American
10 Participants5 Participants8 Participants6 Participants29 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants7 Participants6 Participants8 Participants25 Participants
Race (NIH/OMB)
White
57 Participants63 Participants57 Participants60 Participants237 Participants
Sex: Female, Male
Female
57 Participants54 Participants62 Participants55 Participants228 Participants
Sex: Female, Male
Male
15 Participants21 Participants14 Participants21 Participants71 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 740 / 750 / 760 / 76
other
Total, other adverse events
0 / 740 / 750 / 760 / 76
serious
Total, serious adverse events
0 / 740 / 750 / 760 / 76

Outcome results

Primary

Adherence to the Mobile Application Intervention

Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial

Time frame: Participants will be followed for the duration of the 8 week trial

ArmMeasureValue (MEDIAN)
IntelliCare Hub Recommender, CoachAdherence to the Mobile Application Intervention56 days
IntelliCare Hub Recommender, no CoachAdherence to the Mobile Application Intervention56 days
IntelliCare Hub no Recommender, CoachAdherence to the Mobile Application Intervention56 days
IntelliCare Hub no Recommender, no CoachAdherence to the Mobile Application Intervention56 days
Comparison: Log-rank test of adherence, defined as time to last engagement with mobile application suite.p-value: 0.3Log Rank
Primary

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.

Time frame: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.

Population: Participants with at least one follow-up measure of self-reported anxiety

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
IntelliCare Hub Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 47.66 score on a scaleStandard Error 0.49
IntelliCare Hub Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 86.14 score on a scaleStandard Error 0.49
IntelliCare Hub Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 3 (post treatment)5.70 score on a scaleStandard Error 0.49
IntelliCare Hub Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 6 (post treatment)6.09 score on a scaleStandard Error 0.49
IntelliCare Hub Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 87.68 score on a scaleStandard Error 0.48
IntelliCare Hub Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 3 (post treatment)7.28 score on a scaleStandard Error 0.48
IntelliCare Hub Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 6 (post treatment)6.99 score on a scaleStandard Error 0.49
IntelliCare Hub Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 48.68 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 3 (post treatment)6.45 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 86.88 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 6 (post treatment)6.00 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 47.67 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 6 (post treatment)6.83 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 87.04 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityWeek 47.80 score on a scaleStandard Error 0.48
IntelliCare Hub no Recommender, no CoachGAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety SeverityMonth 3 (post treatment)6.90 score on a scaleStandard Error 0.49
Comparison: Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.p-value: 0.53Mixed Models Analysis
Primary

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.

Time frame: Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.

Population: Participants with at least one follow-up measure of self-reported depression

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
IntelliCare Hub Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 48.87 score on a scaleStandard Error 0.52
IntelliCare Hub Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 86.58 score on a scaleStandard Error 0.52
IntelliCare Hub Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 3 (post treatment)6.52 score on a scaleStandard Error 0.52
IntelliCare Hub Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 6 (post treatment)6.84 score on a scaleStandard Error 0.53
IntelliCare Hub Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 87.90 score on a scaleStandard Error 0.51
IntelliCare Hub Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 3 (post treatment)7.73 score on a scaleStandard Error 0.51
IntelliCare Hub Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 6 (post treatment)8.35 score on a scaleStandard Error 0.51
IntelliCare Hub Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 49.43 score on a scaleStandard Error 0.51
IntelliCare Hub no Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 3 (post treatment)7.62 score on a scaleStandard Error 0.53
IntelliCare Hub no Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 87.76 score on a scaleStandard Error 0.53
IntelliCare Hub no Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 6 (post treatment)7.33 score on a scaleStandard Error 0.53
IntelliCare Hub no Recommender, CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 48.82 score on a scaleStandard Error 0.53
IntelliCare Hub no Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 6 (post treatment)7.72 score on a scaleStandard Error 0.51
IntelliCare Hub no Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 88.20 score on a scaleStandard Error 0.51
IntelliCare Hub no Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityWeek 48.89 score on a scaleStandard Error 0.51
IntelliCare Hub no Recommender, no CoachPatient Health Questionnaire - 9 (PHQ-9) - Depression SeverityMonth 3 (post treatment)8.31 score on a scaleStandard Error 0.51
Comparison: Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.p-value: 0.9Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026