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Telephone-Based Nurse Support for Depression (MI-CARE Trial)
N/A
Waitlist Available
Led By Lynn DeBar, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after randomization
Awards & highlights
MI-CARE Trial Summary
This trial is testing whether offering telephone-based nurse support to patients with depressive symptoms who have taken opioids at some time can improve their health and well-being.
Eligible Conditions
- Depression
- Anxiety
- Opioid Use Disorder
- Chronic Pain
MI-CARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Days of buprenorphine medication treatment for opioid use disorder (OUD)
Secondary outcome measures
Change in depressive symptoms
Other outcome measures
Buprenorphine treatment or improved depressive symptoms
Acute Coryza
Serious opioid related event
MI-CARE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MI-CARE programExperimental Treatment1 Intervention
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.
Group II: Usual careActive Control1 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 is running the clinical trial?
University of New MexicoOTHER
372 Previous Clinical Trials
3,527,985 Total Patients Enrolled
14 Trials studying Depression
2,068 Patients Enrolled for Depression
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,024 Total Patients Enrolled
35 Trials studying Depression
120,080 Patients Enrolled for Depression
Indiana University HealthOTHER
30 Previous Clinical Trials
15,229 Total Patients Enrolled
3 Trials studying Depression
970 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have serious trouble with thinking and understanding.Your depression screening score was 10 or higher in the past 7 days.In the past year, there is proof that you may have a problem with opioid use.You have been diagnosed with Alzheimer's disease or dementia in the 2 years before and including the date of the qualifying PHQ.You have received chemotherapy or radiation therapy for cancer in the past 3 months, not including treatment for non-melanoma skin cancers.You have a diagnosis code for opioid use disorder (OUD) in any setting except labs.You have received hospice care in the 2 years before and including the date of the qualifying PHQ score.You are currently receiving or participating in depression care management at Kaiser Permanente Washington.You are 18 years old or older.You have taken medication for Alzheimer's or dementia in the two years before the qualifying date.You have undergone a specific medical procedure related to buprenorphine, which is used to treat opioid use disorder.You have been diagnosed with an opioid overdose.You have been prescribed buprenorphine for opioid use disorder in any form.You have been diagnosed with opioid use disorder (OUD) and have been prescribed or received injectable naltrexone.
Research Study Groups:
This trial has the following groups:- Group 1: MI-CARE program
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to join this clinical research?
"Clinicaltrials.gov confirms that this medical trial, which initially commenced on November 10th 2021, is no longer recruiting participants. Although it has concluded its recruitment phase, there are 1,964 other studies actively enrolling patients at the present moment."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have been dealing with extreme depression and anxiety and I did something stupid by taking opiates thinking that they would help me but it's the opposite. I'm suffering with withdrawals and I don't know what to do but I definitely don't want to take those drugs anymore and I need help! I am a 74 year old woman.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Will or can I be excepted because of my age. Can I get help without having to travel, don't drive?
PatientReceived no prior treatments
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