DepressionMI-CARENCT05122676
More Individualized Care: Assessment and Recovery Through Engagement
A study testing More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) in people with Depression and Anxiety, run by Kaiser Permanente at 2 sites in United States.
Trial summary
The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time. The study tests whether offering nurse support to the patient and their primary care team that addresses these things and related issues can improve patients'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Opioid-Related Disorders
- What is being tested?
- More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must meet all 4 criteria:
- ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date);
- Age ≥18 years at the pull date;
- ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date.
- Evidence of potential OUD in the 365 days prior to and including the date of the qualifying PHQ-9 score. Any 1 of the following qualifies as evidence of potential OUD:
- ≥1 active OUD ICD-10 diagnosis code in any setting except labs;
Show all 10Show fewer
- ≥1 prescription (orders or dispensed) for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
- ≥1 procedure code for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant);
- ≥1 ICD-10 codes for opioid overdose;
- ≥1 OUD ICD-10 code, including remission, and prescription (orders or dispensed) or procedure code for injectable naltrexone.
Who cannot join
- Patients are ineligible who meet any of the criteria below:
- The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2;
- The patient has already been randomized to the trial or was outreached in the pilot study (including outreach to the primary care provider only);
- English interpreter required (per health system records).
- Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ:
- Alzheimer's disease or dementia diagnosis, or medication to treat Alzheimer's or dementia.
Show all 11Show fewer
- Severe cognitive limitations.
- Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers).
- Previously requested to not participate in research studies at the health system;
- Documentation of hospice care in the 2 years prior to and including the date of the qualifying PHQ score;
- Patient is actively being outreached for (or is participating in) depression care management (Kaiser Permanente Washington only)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health
Indianapolis, Indiana, 46202
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time. The study tests whether offering nurse support to the patient and their primary care team that addresses these things and related issues can improve patients' health and well-being. Eligible subjects are identified automatically using health system data and randomly assigned 50:50 to either a no-contact usual care arm or to the arm offered the MI-CARE program.
Read the detailed description
The MI-CARE trial is a randomized encouragement trial that will test whether offering a primary care-based collaborative care (CC) model can increase opioid use disorder (OUD) treatment and improve depression outcomes among patients with:
- recent electronic health record (EHR) documentation of depressive symptoms, and
- evidence of OUD documented in the prior year.
The study objective is to evaluate the effectiveness of offering eligible primary care patients the MI-CARE CC program for up to 12 months when compared to usual primary care. Among all eligible primary care patients, MI-CARE and usual primary care will be compared to assess the following outcomes:
- Aim 1: Days of OUD medication treatment (buprenorphine)
- Aim 2: Improvement of depression symptoms.
- Aim 3 (intervention arm only): Examining a) implementation using mixed-methods formative evaluation including reach, adoption, and implementation fidelity, and b) nurse care manager time needed to support the MICARE intervention.
The MI-CARE CC intervention is offered by a nurse care manager (NCM) and delivered by telephone (or video) visits to consenting patients. The intervention is designed to support "whole health" by engaging patients in medication treatment for OUD and depression, reducing depressive symptoms, and addressing common comorbid conditions that complicate OUD and depression (e.g., anxiety, pain, sleep, and other mental health and substance use disorders).
The Collaborative Care Model was originally designed to improve mental health outcomes in primary care and includes 5 essential elements. The CC intervention tested in the MI-CARE trial will include each of these elements: population-based care, patient-centered team care, evidence-based care, measurement-based treatment to target, and accountable care.
The MI-CARE program begins with NCM care focused on PCP and patient engagement:
- Care team engagement - In addition to engaging the patient, the engagement process is designed to build the relationship between the NCM and the primary care team. Prior to a patient's first outreach call, the NCM informs the PCP that their patient was selected for the CC program and offers to have an initial brief (optional) call about the program with the care team. The NCM may also reach out to engage with specialty mental health providers who are working closely with the patient. If the patient does not have an established PCP, the NCM will offer to work with the patient to establish a PCP within the healthcare system. Additionally, each site's collaborative care consultants will message PCPs in their health plan when a given PCP's patient consents to participate in the MICARE intervention. These messages are to inform the PCP of the support the CC consultants provide each NCM in the management of consented patients to the intervention (including that the CC consultant's role may include various recommendations regarding patient care).
- Patient engagement - This begins with a short series of "engagement" sessions to develop a relationship with the patient. Engagement sessions focus on eliciting a patient's health narrative, including current symptoms, and exploring the patient's (general) health goals, priorities, and preferences. Prior to the first engagement call the NCM reviews the patient's chart to obtain current treatment(s) for depression, OUD and related conditions. The NCM will build rapport by learning about patients' lives, how they are impacted by their health, eliciting the patients' thoughts on symptoms reported, and exploring how the program might help them. Motivational interviewing and shared decision-making techniques are used to elicit patient goals and priorities.
Beginning with engagement and throughout the follow up period, the NCM will use common elements of two evidence-based core behavioral approaches:
- Motivational interviewing (MI) skills to elicit ambivalence and move patients toward wanting to improve OUD, depression or other related conditions; and
- Behavioral activation (BA) to help participants build skills to increase positive adaptive experiences in their day-to-day lives and support broader treatment gains.
- Conditions
- Depression, Anxiety, Opioid-Related Disorders, Pain, Chronic
- Being tested
- More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
- Keywords
- Primary health care, Primary care, Primary care nursing, Evidence-based care, Depressive symptoms, Anxiety disorders and symptoms, Mental Health, Mental Health disorder, Opioid use, Opioid misuse, Opioid use disorder, Opioid dependence, Buprenorphine, Substance use disorders, Overdose, Overdose of opiate, Opioid overdose, Motivational Interviewing, Brief psychotherapy
- Medical subject headings
- Depression, Anxiety Disorders, Opioid-Related Disorders, Chronic Pain, Psychological Well-Being, Mental Disorders, Substance-Related Disorders, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)Behavioural
This study evaluates whether offering nurse collaborative care management for 12 months by telephone or video can improve depression-related symptoms, increase access to evidence-based medication treatment for opioid use problems, as well as decreasing adverse health events. Participants randomized to the nurse support arm can work with the nurse at no cost for up to 12 months via phone or video visits.
The nurse asks questions about stress, mood, worry, pain, sleep, and medication and substance use; participants choose what to focus on. The nurse meets weekly with clinical consultants who may recommend treatment options, tailored to the patient. The participant and their regular provider(s) can discuss the options and decide which to try. The nurse and primary care provider can then help the patient access selected options. The nurse can also offer behavioral activation to help build skills to increase day-to-day positive adaptive experiences and support broader treatment gains.
| Study group | Role | What they receive |
|---|---|---|
| MI-CARE program | Experimental | Those automatically identified as eligible and randomized to the MI-CARE arm are outreached by a study nurse care manager and offered the 12-month long virtual Collaborative Care program by telephone or video visits. Individuals are free to accept or decline the offer (e.g., stop/restart, not accept right away) during the 12 months after their randomization date. Receives: Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) |
| Usual care | No intervention | Those identified as eligible and randomized to the usual care arm have no contact with the study. All outcome data for both study arms are collected from secondary, electronic sources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of buprenorphine medication treatment for opioid use disorder (OUD)
A continuous measure of days of OUD treatment with buprenorphine in the 365 days after randomization from secondary electronic data sources.
Measured: days 1-365 after randomization
Secondary outcomes (1)
Change in depressive symptoms
Change in depressive symptoms from the study qualifying Patient Health Questionnaire (PHQ) score to follow-up PHQ score documented as part of routine clinical care 3-13. months later from secondary electronic data sources. The 9-item Patient Health Questionnaire (PHQ9) has a minimum score of 0 and a maximum score of 27. the 2-item Patient Health Questionnaire (PHQ2) has a minimum score of 0 and a maximum score of 6. An increasing PHQ score indicates an increase in depressive symptoms.
Measured: 3-13 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start10 Nov 2021
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, National Institute of Mental Health (NIMH), Boston Medical Center, University of New Mexico, University of Washington, Purdue University, Montana State University
- Responsible party
- Sponsor
- Investigators
- Lynn DeBar, PhD, Principal investigator, Kaiser PermanenteKatharine A Bradley, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122676
- Sponsor's protocol ID
- UF1MH121949
- Other IDs
- 1UF1MH121949-01, 4UF1MH121949
- Acronym
- MI-CARE
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The MI-CARE trial will involve analysis of a large amount of detailed proprietary secondary electronic health plan data from the Kaiser Permanente Washington and Indiana University Health systems, and state-wide datasets, e.g., prescription monitoring programs (PMPs). We will seek to obtain data use agreements that allow us to share all de-identified data. However, if that is not possible, we will share those de-identified data for which we do have permission to share.
Publications
DeBar LL, Bushey MA, Kroenke K, Bobb JF, Schoenbaum M, Thompson EE, Justice M, Zatzick D, Hamilton LK, McMullen CK, Hallgren KA, Benes LL, Forman DP, Caldeiro RM, Brown RP, Campbell NL, Anderson ML, Son S, Haggstrom DA, Whiteside L, Schleyer TKL, Bradley KA. A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial. Contemp Clin Trials. 2023 Apr;127:107124. doi: 10.1016/j.cct.2023.107124. Epub 2023 Feb 18.
PubMed 36804450
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Team-based Primary Care to Treat Opioid Use Disorder, Depression, and Other Conditions
- ClinicalTrials.gov ID
- NCT05122676
- Acronym / sponsor ID
- MI-CARE / UF1MH121949
- Conditions
- Depression, Anxiety, Opioid-Related Disorders, Pain, Chronic
- Keywords
- Primary health care, Primary care, Primary care nursing, Evidence-based care, Depressive symptoms, Anxiety disorders and symptoms, Mental Health, Mental Health disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Indiana University Health, National Institute of Mental Health (NIMH), Boston Medical Center, University of New Mexico, University of Washington, Purdue University, Montana State University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MI-CARE trial tests 12 months of telephone-based nurse care management for patients with depressive symptoms who take or have taken opioids at some time. The study tests whether offering nurse support to the patient and their primary care team that addresses these things and related issues can improve patients' health and well-being. Eligible subjects are identified automatically using health system data and randomly assigned 50:50 to either a no-contact usual care arm or to the arm offered the MI-CARE program.
Detailed description
The MI-CARE trial is a randomized encouragement trial that will test whether offering a primary care-based collaborative care (CC) model can increase opioid use disorder (OUD) treatment and improve depression outcomes among patients with:
- recent electronic health record (EHR) documentation of depressive symptoms, and
- evidence of OUD documented in the prior year.
The study objective is to evaluate the effectiveness of offering eligible primary care patients the MI-CARE CC program for up to 12 months when compared to usual primary care. Among all eligible primary care patients, MI-CARE and usual primary care will be compared to assess the following outcomes:
- Aim 1: Days of OUD medication treatment (buprenorphine)
- Aim 2: Improvement of depression symptoms.
- Aim 3 (intervention arm only): Examining a) implementation using mixed-methods formative evaluation including reach, adoption, and implementation fidelity, and b) nurse care manager time needed to support the MICARE intervention.
The MI-CARE CC intervention is offered by a nurse care manager (NCM) and delivered by telephone (or video) visits to consenting patients. The intervention is designed to support "whole health" by engaging patients in medication treatment for OUD and depression, reducing depressive symptoms, and addressing common comorbid conditions that complicate OUD and depression (e.g., anxiety, pain, sleep, and other mental health and substance use disorders).
The Collaborative Care Model was originally designed to improve mental health outcomes in primary care and includes 5 essential elements. The CC intervention tested in the MI-CARE trial will include each of these elements: population-based care, patient-centered team care, evidence-based care, measurement-based treatment to target, and accountable care.
The MI-CARE program begins with NCM care focused on PCP and patient engagement:
- Care team engagement - In addition to engaging the patient, the engagement process is designed to build the relationship between the NCM and the primary care team. Prior to a patient's first outreach call, the NCM informs the PCP that their patient was selected for the CC program and offers to have an initial brief (optional) call about the program with the care team. The NCM may also reach out to engage with specialty mental health providers who are working closely with the patient. If the patient does not have an established PCP, the NCM will offer to work with the patient to establish a PCP within the healthcare system. Additionally, each site's collaborative care consultants will message PCPs in their health plan when a given PCP's patient consents to participate in the MICARE intervention. These messages are to inform the PCP of the support the CC consultants provide each NCM in the management of consented patients to the intervention (including that the CC consultant's role may include various recommendations regarding patient care).
- Patient engagement - This begins with a short series of "engagement" sessions to develop a relationship with the patient. Engagement sessions focus on eliciting a patient's health narrative, including current symptoms, and exploring the patient's (general) health goals, priorities, and preferences. Prior to the first engagement call the NCM reviews the patient's chart to obtain current treatment(s) for depression, OUD and related conditions. The NCM will build rapport by learning about patients' lives, how they are impacted by their health, eliciting the patients' thoughts on symptoms reported, and exploring how the program might help them. Motivational interviewing and shared decision-making techniques are used to elicit patient goals and priorities.
Beginning with engagement and throughout the follow up period, the NCM will use common elements of two evidence-based core behavioral approaches:
- Motivational interviewing (MI) skills to elicit ambivalence and move patients toward wanting to improve OUD, depression or other related conditions; and
- Behavioral activation (BA) to help participants build skills to increase positive adaptive experiences in their day-to-day lives and support broader treatment gains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-CARE program | Experimental | Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)Those automatically identified as eligible and randomized to the MI-CARE arm are outreached by a study nurse care manager and offered the 12-month long virtual Collaborative Care program by telephone or video visits. Individuals are free to accept or decline the offer (e.g., stop/restart, not accept right away) during the 12 months after their randomization date. |
| Usual care | No intervention | –Those identified as eligible and randomized to the usual care arm have no contact with the study. All outcome data for both study arms are collected from secondary, electronic sources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date);
- Age ≥18 years at the pull date;
- ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date.
- Evidence of potential OUD in the 365 days prior to and including the date of the qualifying PHQ-9 score. Any 1 of the following qualifies as evidence of potential OUD:
Key exclusion criteria (11 listed)
- The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2;
- The patient has already been randomized to the trial or was outreached in the pilot study (including outreach to the primary care provider only);
- English interpreter required (per health system records).
- Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ:
- Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers).
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 |
|---|---|---|
| More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)This study evaluates whether offering nurse collaborative care management for 12 months by telephone or video can improve depression-related symptoms, increase access to evidence-based medication treatment for opioid use problems, as well as decreasing adverse health events. Participants randomized to the nurse support arm can work with the nurse at no cost for up to 12 months via phone or video visits. The nurse asks questions about stress, mood, worry, pain, sleep, and medication and substance use; participants choose what to focus on. The nurse meets weekly with clinical consultants who may recommend treatment options, tailored to the patient. The participant and their regular provider(s) can discuss the options and decide which to try. The nurse and primary care provider can then help the patient access selected options. The nurse can also offer behavioral activation to help build skills to increase day-to-day positive adaptive experiences and support broader treatment gains. | Behavioural | MI-CARE program |
Primary outcome
Days of buprenorphine medication treatment for opioid use disorder (OUD)
Time frame: days 1-365 after randomization
A continuous measure of days of OUD treatment with buprenorphine in the 365 days after randomization from secondary electronic data sources.
1 secondary outcome
Change in depressive symptoms
Time frame: 3-13 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 36804450DeBar LL, Bushey MA, Kroenke K, Bobb JF, Schoenbaum M, Thompson EE, Justice M, Zatzick D, Hamilton LK, McMullen CK, Hallgren KA, Benes LL, Forman DP, Caldeiro RM, Brown RP, Campbell NL, Anderson ML, Son S, Haggstrom DA, Whiteside L, Schleyer TKL, Bradley KA. A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial. Contemp Clin Trials. 2023 Apr;127:107124. doi: 10.1016/j.cct.2023.107124. Epub 2023 Feb 18.
- Individual participant dataSharing planned: Yes. The MI-CARE trial will involve analysis of a large amount of detailed proprietary secondary electronic health plan data from the Kaiser Permanente Washington and Indiana University Health systems, and state-wide datasets, e.g., prescription monitoring programs (PMPs). We will seek to obtain data use agreements that allow us to share all de-identified data. However, if that is not possible, we will share those de-identified data for which we do have permission to share.
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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.
Lynn DeBar, PhD principal investigator
Kaiser Permanente
Katharine A Bradley, MD, MPH principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) in people with Depression and Anxiety, run by Kaiser Permanente at 2 sites 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 10 inclusion and 11 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days of buprenorphine medication treatment for opioid use disorder (OUD) (time frame: days 1-365 after randomization). 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 NCT05122676, which also lists 1 linked publication.
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 30 Mar 2026.