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

Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176226
Enrollment
105
Registered
2014-06-27
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2023-04-26

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

Conditions

Anxiety Disorders, Major Depressive Disorder

Keywords

Major Depressive Disorder, Anxiety Disorders, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App

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.

Interventions

BEHAVIORALIntelliCare

Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleBaseline, Week 4, and Week 8The 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)Baseline, Week 4, and Week 8The 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.

Secondary

MeasureTime frame
Mean Number of Treatment App Use Sessions by Study WeekWeekly for Two Months

Countries

United States

Participant flow

Participants by arm

ArmCount
8-Week Single Arm Field Trial
Use of IntelliCare program for 8 weeks. IntelliCare: Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
105
Total105

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3
Overall StudyWithdrew prior to treatment6

Baseline characteristics

Characteristic8-Week Single Arm Field Trial
Age, Continuous36 years
Education
2-year college (Associate)
16 Participants
Education
4-year college (BA, BS)
37 Participants
Education
Completed high school or GED
4 Participants
Education
Doctoral degree
4 Participants
Education
Master's degree
22 Participants
Education
Professional degree (MD, JD)
1 Participants
Education
Some college
20 Participants
Education
Some high school
1 Participants
Employment status
Disability
8 Participants
Employment status
Employed
76 Participants
Employment status
Other
5 Participants
Employment status
Retired
5 Participants
Employment status
Unemployed
11 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Income, yearly household income63,000 USD
Income, yearly personal gross income35,000 USD
Marital Status
Divorced
13 Participants
Marital Status
Living with significant other
15 Participants
Marital Status
Married or domestic partner
38 Participants
Marital Status
Separated
1 Participants
Marital Status
Single
35 Participants
Marital Status
Widowed
3 Participants
Number of hours per week spent working40 hours per week spent working
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
6 Participants
Race (NIH/OMB)
Black or African American
8 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
88 Participants
Recruitment Source
HealthPartners Healthcare system
38 Participants
Recruitment Source
Other
40 Participants
Recruitment Source
ResearchMatch
11 Participants
Recruitment Source
Web or social media
16 Participants
Sex: Female, Male
Female
80 Participants
Sex: Female, Male
Male
25 Participants
Treatment
None
16 Participants
Treatment
Pharmacotherapy
66 Participants
Treatment
Psychotherapy
23 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 105
serious
Total, serious adverse events
0 / 105

Outcome results

Primary

GAD-7 (Generalized Anxiety Disorder Scale-7)

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: Baseline, Week 4, and Week 8

Population: Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.

ArmMeasureGroupValue (MEAN)Dispersion
8-Week Single Arm Field TrialGAD-7 (Generalized Anxiety Disorder Scale-7)Baseline10.9 units on a scaleStandard Deviation 4.5
8-Week Single Arm Field TrialGAD-7 (Generalized Anxiety Disorder Scale-7)Week 47.1 units on a scaleStandard Deviation 3.9
8-Week Single Arm Field TrialGAD-7 (Generalized Anxiety Disorder Scale-7)Week 85.8 units on a scaleStandard Deviation 4
p-value: <0.001t-test, 2 sided
Primary

Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

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: Baseline, Week 4, and Week 8

Population: Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.

ArmMeasureGroupValue (MEAN)Dispersion
8-Week Single Arm Field TrialPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleBaseline12.5 units on a scaleStandard Deviation 4.3
8-Week Single Arm Field TrialPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 48.4 units on a scaleStandard Deviation 4.1
8-Week Single Arm Field TrialPatient Health Questionnaire - 9 (PHQ-9) - Depression Severity ModuleWeek 86.4 units on a scaleStandard Deviation 4.3
p-value: <0.001t-test, 2 sided
Secondary

Mean Number of Treatment App Use Sessions by Study Week

Time frame: Weekly for Two Months

Population: Of the 99 participants who initiated the treatment, 96.0% (95/99) continued to use the apps at week 5 and 90.1% (90/99) continued through week 8.

ArmMeasureGroupValue (MEAN)Dispersion
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 823.3 number of treatment app use sessionsStandard Deviation 25.57
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 723.44 number of treatment app use sessionsStandard Deviation 22.27
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 120.09 number of treatment app use sessionsStandard Deviation 15.63
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 222.79 number of treatment app use sessionsStandard Deviation 16.76
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 324.1 number of treatment app use sessionsStandard Deviation 20.21
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 425.33 number of treatment app use sessionsStandard Deviation 20.68
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 526.07 number of treatment app use sessionsStandard Deviation 20.41
8-Week Single Arm Field TrialMean Number of Treatment App Use Sessions by Study WeekWeek 626.25 number of treatment app use sessionsStandard Deviation 23.66

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026