An interventional study of More Individualized Care: Assessment and Recovery through Engagement (MI-CARE) in Depression, Anxiety and Opioid-Related Disorders, sponsored by Kaiser Permanente. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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.
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:
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:
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:
Beginning with engagement and throughout the follow up period, the NCM will use common elements of two evidence-based core behavioral approaches:
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 805 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible patients must meet all 4 criteria:
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:
EXCLUSION CRITERIA
Patients are ineligible who meet any of the criteria below:
Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ:
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.
Behavioral: More Individualized Care: Assessment and Recovery through Engagement (MI-CARE)
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.
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.
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.
Time frame: days 1-365 after randomization
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.
Time frame: 3-13 months after randomization
Buprenorphine treatment or improved depressive symptoms
Composite measure identifying whether a patient is treated with buprenorphine and/or has documentation of clinically-significant improvement in depressive symptoms from secondary electronic data sources: * Treatment with buprenorphine is a binary measure of treatment with buprenorphine formulations for pain or OUD defined as \> 90 days of buprenorphine during the 12-month follow up period. * Clinically significant improvement in depressive symptoms is a binary measure of documented clinical response of depressive symptoms during follow-up (50% decrease in PHQ9 score or negative PHQ2 screen).
Time frame: 1 day - 13 months after randomization
Major acute adverse health events
A composite of any major adverse event over 12 months of follow-up, which includes: opioid overdose, other drug overdose, suicide attempt or other self-harm, hospitalizations (opioid and non-opioid), or death (from secondary electronic data sources).
Time frame: 12 months after randomization
Serious opioid related event
A count of the number of serious opioid-related events over 12 months of follow up; defined as emergency department visits or hospital admissions with a primary OUD or opioid-related diagnosis or an opioid-related overdose (lethal of non-lethal), from secondary electronic data sources.
Time frame: 12 months after randomization
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Access criteria: Although our trial had planned to publicly share data with the NIMH data archive (NDA), they determined on February 24, 2022 that they would remove our grant from NDA data sharing because the subjects in this trial do not have signed consent forms.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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