Major Depressive DisorderNCT02176226
IntelliCare: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
A study testing IntelliCare in people with Major Depressive Disorder and Anxiety Disorders, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Major Depressive Disorder, Anxiety Disorders
- What is being tested?
- IntelliCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Anxiety Disorders
- Being tested
- IntelliCare
- Keywords
- Major Depressive Disorder, Anxiety Disorders, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCareBehavioural
Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
| Study group | Role | What they receive |
|---|---|---|
| 8-Week Single Arm Field Trial | Experimental | Use of IntelliCare program for 8 weeks. Receives: Behavioral: IntelliCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (1)
Mean Number of Treatment App Use Sessions by Study Week
Measured: Weekly for Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C Mohr, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176226
- Sponsor's protocol ID
- R01MH100482-01-FTIC
- Other IDs
- R01MH100482-01
- Status last verified
- Mar 2023
- First submitted
- 25 Jun 2014
- Last updated
- 26 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Interested parties can contact the PI. Data may be made available if proposed analyses are consistent with the IRB regulations and a Data Use Agreement is established
Publications
Rubanovich CK, Mohr DC, Schueller SM. Health App Use Among Individuals With Symptoms of Depression and Anxiety: A Survey Study With Thematic Coding. JMIR Ment Health. 2017 Jun 23;4(2):e22. doi: 10.2196/mental.7603.
PubMed 28645891Mohr DC, Tomasino KN, Lattie EG, Palac HL, Kwasny MJ, Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L, Stiles-Shields C, Schueller SM. IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. J Med Internet Res. 2017 Jan 5;19(1):e10. doi: 10.2196/jmir.6645.
PubMed 28057609
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
- ClinicalTrials.gov ID
- NCT02176226
- Acronym / sponsor ID
- R01MH100482-01-FTIC
- Conditions
- Major Depressive Disorder, Anxiety Disorders
- Keywords
- Major Depressive Disorder, Anxiety Disorders, Behavior Therapy, Technology Assisted, Mobile Phone, Cellular Phone, Smartphone, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8-Week Single Arm Field Trial | Experimental | Behavioral: IntelliCareUse of IntelliCare program for 8 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntelliCareBehavioral interventions for depression and anxiety via a mobile phone application, IntelliCare. | Behavioural | 8-Week Single Arm Field Trial |
Primary outcome
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Time frame: Baseline, Week 4, and Week 8
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)
Time frame: Baseline, Week 4, and Week 8
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.
1 secondary outcome
Mean Number of Treatment App Use Sessions by Study Week
Time frame: Weekly for Two Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28645891Rubanovich CK, Mohr DC, Schueller SM. Health App Use Among Individuals With Symptoms of Depression and Anxiety: A Survey Study With Thematic Coding. JMIR Ment Health. 2017 Jun 23;4(2):e22. doi: 10.2196/mental.7603.
- Derived from this study: PubMed 28057609Mohr DC, Tomasino KN, Lattie EG, Palac HL, Kwasny MJ, Weingardt K, Karr CJ, Kaiser SM, Rossom RC, Bardsley LR, Caccamo L, Stiles-Shields C, Schueller SM. IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. J Med Internet Res. 2017 Jan 5;19(1):e10. doi: 10.2196/jmir.6645.
- Individual participant dataSharing planned: No. Interested parties can contact the PI. Data may be made available if proposed analyses are consistent with the IRB regulations and a Data Use Agreement is established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Mohr, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare in people with Major Depressive Disorder and Anxiety Disorders, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module (time frame: Baseline, Week 4, and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02176226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.