Collaboration Leading to Addiction Treatment and Recovery From Other Stresses (CLARO)

Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.

Study Overview

• Status: Completed
• Conditions: Depression; Addiction; Opioid-use Disorder; Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Collaborative Care

Detailed Description

Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).

The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).

• Study Type: Interventional
• Enrollment (Actual): 729
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90003
      • Hubert Humphrey Comprehensive Health Center
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • First Choice Community Healthcare - South Broadway Medical Center
    • Albuquerque, New Mexico, United States, 87105
      • First Choice Community Healthcare - South Valley Medical/Dental Center
    • Albuquerque, New Mexico, United States, 87107
      • First Choice - Alameda Medical Center
    • Albuquerque, New Mexico, United States, 87107
      • First Choice Community Healthcare - North Valley Medical Center
    • Albuquerque, New Mexico, United States, 87107
      • University of New Mexico Family Health Clinic, North Valley
    • Albuquerque, New Mexico, United States, 87108
      • University of New Mexico Family Health Clinic, Southeast Heights
    • Albuquerque, New Mexico, United States, 87121
      • First Choice Community Healthcare - Alamosa Medical Center
    • Albuquerque, New Mexico, United States, 87121
      • University of New Mexico Internal Medicine Clinic, Southwest Mesa
    • Belen, New Mexico, United States, 87002
      • First Choice Community Healthcare - Belen Medical Center
    • Edgewood, New Mexico, United States, 87015
      • First Choice Community Healthcare - Edgewood Medical/Dental Center
    • Lordsburg, New Mexico, United States, 88045
      • Hidalgo Medical Services - Lordsburg Clinic
    • Los Lunas, New Mexico, United States, 87031
      • First Choice Community Healthcare - Los Lunas Medical/Dental Center
    • Silver City, New Mexico, United States, 88061
      • Hidalgo Medical Services - Community Health Center
    • Silver City, New Mexico, United States, 88061
      • Hidalgo Medical Services - Med Square Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 and older
• Receiving primary care at one of the participating clinical sites
• Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)

Exclusion Criteria:

• Under 18
• Does not speak English or Spanish
• Unable to consent
• Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled
• Not receiving primary care at one of the participating clinical sites

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in this arm will receive enhanced usual care.
Experimental: Collaborative Care; Intervention is administered to patients in this arm. Care to be delivered via collaborative care.	Behavioral: Collaborative Care; Collaborative care consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buprenorphine access	Number of days until first buprenorphine prescription after study enrollment for study participants with a new episode of OUD care (no care for at least 30 days prior). Obtained from the Prescription Drug Monitoring Program and patient survey.	Assessed at 6 months after study entry.
Buprenorphine continuity of care	The cumulative number of days the patient receives buprenorphine during the 180 days after study enrollment for study participants not on methadone at baseline. Obtained from the Prescription Drug Monitoring Program and patient survey.	Assessed at 6 months after study entry.
Major Depressive Disorder (MDD) symptom severity	Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.	Assessed at 6 months after study entry.
Post-traumatic Stress Disorder (PTSD) symptom severity	Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.	Assessed at 6 months after study entry.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access to MDD and/or PTSD treatment	Receipt of medication and/or behavioral treatment associated with an MDD or PTSD diagnosis within 30 days of study enrollment (initial) or within 180 days of study enrollment (any) for study participants who did not have any visits (behavioral health treatment or medication) for MDD and/or PTSD in 30 days prior to study enrollment. Obtained from patient survey and electronic medical records.	Assessed at 30 days and 180 days after study entry.
Quality of care for MDD	Four psychotherapy visits in the first six months or an adequate (60 day) medication trial for new episodes of MDD care (completed within 6 months) for study participants with probable MDD at baseline and a new episode of MDD care (no MDD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.	Assessed at 6 months after study entry.
Quality of care for PTSD	Four psychotherapy visits in the first six months or an adequate (60 days) medication trial for new episodes of PTSD care (completed within 6 months) for study participants with probable PTSD at baseline, and a new episode of PTSD care (no PTSD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.	Assessed at 6 months after study entry.
MDD remission	Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score less than 5 at 6 months for study participants with probable MDD at baseline.	Assessed at 6 months after study entry
MDD response	Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score at 6 months less than 50% of baseline score for participants with probable MDD at baseline.	Assessed at 6 months after study entry.
PTSD remission	Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score less than 34 at 6 months for study participants with probable PTSD at baseline.	Assessed at 6 months after study entry.
PTSD response	Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score at 6 months less than 50% of baseline score for study participants with probable PTSD at baseline.	Assessed at 6 months after study entry.
Active suicidal ideation	Dichotomized Columbia Suicide Severity Rating Scale at 6 months. Endorsed if participants answer YES to Question 3, 4, and/or 5 and/or YES to Question 7. Obtained from patient survey.	Assessed at 6 months after study entry.
Opioid use frequency	Days of opioid use in the past 30 days from National Survey on Drug Use and Health. Obtained from patient survey.	Assessed over 30 days after study entry.
Opioid overdose events	Opioid overdose events (at least 1 event) in the previous three months. Obtained from patient survey.	Assessed over the previous 3 months after study entry.
Physical health functioning	Physical health measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) physical health subscale.	Assessed at 30 days after study entry
Mental health functioning	Mental health functioning measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) mental health subscale.	Assessed at 30 days after study entry

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current MDD/PTSD treatment	NSDUH items; assessed as a covariate; obtained from patient interview	Assessed over the previous 30 days at study entry
Prior experience with a care coordinator	Assessed as a covariate; obtained from patient interview	Assessed over the previous 12 months at study entry
Disability and impairment	3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview	Assessed over the previous 7 days at study entry
Ability to access treatment quickly	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Satisfaction with treatment	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
History of MOUD treatment	Assessed as a covariate; obtained from patient interview	Asked about lifetime MOUD treatment; assessed at study entry
Patient-care manager working alliance	Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Clinician (care coordinator) communication	Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Pain levels	Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview	Assessed over the previous 7 days at study entry and at 3 and 6 months after study entry
Homelessness	Homelessness Screening Clinical Reminder Tool and one item from the Government Performance and Results Act (GPRA) clarifying where individuals who are homeless are currently living; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at study entry
Drug use frequency	Maximum days of use in the past 30 days for five drug categories using items from National Survey on Drug Use and Health (prescription opioids, heroin, cocaine/crack, methamphetamine/ other stimulants, and tranquilizers/sedatives). Obtained from patient survey.	Assessed over 30 days after study entry.
Stimulant use frequency	Days of stimulant use (cocaine/crack, methamphetamine/ other stimulants) in the past 30 days from the National Survey on Drug Use and Health. Obtained from patient survey.	Assessed over 30 days after study entry.
Alcohol use	Sum of items (0-12) in the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months.	Assessed over 3 months after study entry.
Opioid overdose risk behaviors	Sum of 32-items in the Opioid Overdose Risk Assessment.	Assessed over 3 months after study entry.
Opioid use severity	Sum of items (7-35) in the Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days. Obtained from patient survey.	Assessed over 30 days after study entry.
Demographics	Self-reported demographics on age, sex, race/ethnicity, educational attainment, and marital status.	Assessed at study entry.

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: National Institute of Mental Health (NIMH); University of Pittsburgh; Boston Medical Center; Stanford University; University of New Mexico; Hidalgo Medical Services; First Choice Community Healthcare; Olive View-UCLA Education & Research Institute; Saint John's Cancer Institute
• Investigators: Principal Investigator: Miriam Komaromy, Boston Medical Center; Principal Investigator: Katherine Watkins, RAND

Publications and helpful links

General Publications

• Osilla KC, Dopp AR, Watkins KE, Ceballos V, Hurley B, Meredith LS, Leamon I, Jacobsohn V, Komaromy M. Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Addict Sci Clin Pract. 2022 Apr 8;17(1):25. doi: 10.1186/s13722-022-00302-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Addiction; Collaborative care; Medication for addiction treatment; Problem solving therapy; Written exposure therapy; Opioid-use disorder
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Opioid-Related Disorders; Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Behavior, Addictive
• Other Study ID Numbers: 1UF1MH121954 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per National Institute of Mental Health (NIMH) funding requirements, study data must be uploaded to the NIMH National Data Archive (NDA) every six months once data collection begins. A universal subject identifier called a Global Unique Identifier (GUID) will be generated for each participant. All raw data will be uploaded every six months to the NIMH NDA per their policies. Additionally, all analysis data sets used for manuscripts must be uploaded to the NIMH NDA, identified by GUID.
• IPD Sharing Time Frame: Every 6 months (January and July) following enrollment of the first patient. First submission expected July 2021. Submission will cease following sharing of final analysis data set for any specified outcomes publications.
• IPD Sharing Access Criteria: Per NIMH NDA policies (https://nda.nih.gov/)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No