An interventional study of IntelliCare and Hub App with the Recommender System in Depression and Anxiety, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 301 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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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.
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and receive coaching for the 8 week IntelliCare program.
Behavioral: IntelliCare · Behavioral: Hub App with the Recommender System · Behavioral: Coaching
Participant is randomly assigned to receive the IntelliCare Hub App with the recommender system, and independently use the IntelliCare program for 8 weeks.
Behavioral: IntelliCare · Behavioral: Hub App with the Recommender System
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and receive coaching for the 8 week IntelliCare program.
Behavioral: IntelliCare · Behavioral: Coaching
Participant is randomly assigned to receive the IntelliCare Hub App without the recommender system, and independently use the IntelliCare program for 8 weeks.
Behavioral: IntelliCare
Also known as: Behavioral intervention for depression & anxiety via app
Also known as: Recommender via IntelliCare Hub app.
Also known as: Support from coach via phone calls and messaging
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
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.
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.
| Milestone | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach |
|---|---|---|---|---|
| Started | 74 | 75 | 76 | 76 |
| Completed | 71 | 74 | 70 | 76 |
| Not completed | 3 | 1 | 6 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 | 0 |
| Withdrew: Never started treatment | 2 | 0 | 4 | 0 |
Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial
| days | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach |
|---|---|---|---|---|
| Adherence to the Mobile Application Intervention | 56 (56 to 56) | 56 (56 to 56) | 56 (55 to 56) | 56 (53 to 56) |
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.
| score on a scale | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach |
|---|---|---|---|---|
| Week 4 | 8.87 ± 0.52 | 9.43 ± 0.51 | 8.82 ± 0.53 | 8.89 ± 0.51 |
| Week 8 | 6.58 ± 0.52 | 7.90 ± 0.51 | 7.76 ± 0.53 | 8.20 ± 0.51 |
| Month 3 (post treatment) | 6.52 ± 0.52 | 7.73 ± 0.51 | 7.62 ± 0.53 | 8.31 ± 0.51 |
| Month 6 (post treatment) | 6.84 ± 0.53 | 8.35 ± 0.51 | 7.33 ± 0.53 | 7.72 ± 0.51 |
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.
| score on a scale | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach |
|---|---|---|---|---|
| Week 4 | 7.66 ± 0.49 | 8.68 ± 0.48 | 7.67 ± 0.48 | 7.80 ± 0.48 |
| Week 8 | 6.14 ± 0.49 | 7.68 ± 0.48 | 6.88 ± 0.48 | 7.04 ± 0.48 |
| Month 3 (post treatment) | 5.70 ± 0.49 | 7.28 ± 0.48 | 6.45 ± 0.48 | 6.90 ± 0.49 |
| Month 6 (post treatment) | 6.09 ± 0.49 | 6.99 ± 0.49 | 6.00 ± 0.48 | 6.83 ± 0.48 |
Collected over Screening through 6 months post treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IntelliCare Hub Recommender, Coach | 0/74 (0%) | 0/74 (0%) | 0/74 (0%) |
| IntelliCare Hub Recommender, no Coach | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| IntelliCare Hub no Recommender, Coach | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| IntelliCare Hub no Recommender, no Coach | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Age, Continuous(years) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| Mean | 37.6 ± 12.2 | 36.2 ± 11.5 | 37.1 ± 12.3 | 35.3 ± 11.5 | 36.5 ± 11.8 |
| Sex: Female, Male(Participants) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| Female | 57 | 54 | 62 | 55 | 228 |
| Male | 15 | 21 | 14 | 21 | 71 |
| Ethnicity (NIH/OMB)(Participants) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 7 | 5 | 30 |
| Not Hispanic or Latino | 62 | 67 | 68 | 71 | 268 |
| Unknown or Not Reported | 2 | 0 | 1 | 0 | 3 |
| Race (NIH/OMB)(Participants) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 0 | 5 | 2 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 5 | 8 | 6 | 29 |
| White | 57 | 63 | 57 | 60 | 237 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 7 | 6 | 8 | 25 |
| Patient Health Questionaire 9 (PHQ-9)(units on a scale) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| Mean | 12.78 ± 4.45 | 13.24 ± 4.55 | 13.11 ± 4.75 | 13.70 ± 4.79 | 13.21 ± 4.63 |
| Generalized Anxiety Disorder 7 (GAD-7)(units on a scale) | IntelliCare Hub Recommender, Coach | IntelliCare Hub Recommender, no Coach | IntelliCare Hub no Recommender, Coach | IntelliCare Hub no Recommender, no Coach | Total |
|---|---|---|---|---|---|
| Mean | 11.86 ± 4.05 | 11.88 ± 3.85 | 12.33 ± 4.51 | 11.84 ± 3.66 | 11.98 ± 4.02 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
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