Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Conditions

Addiction, Depression, Opioid-use Disorder, Post-traumatic Stress Disorder

Keywords

Collaborative care, Problem solving therapy, Written exposure therapy, Medication for addiction treatment, Addiction, Opioid-use disorder

Brief summary

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.

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).

Miriam Komaromy, Lisa S. Meredith, Maya Rabinowitz, Colleen McCullough, Lauren Kelly et al. (8 authors)

BMC Primary Care2026-02-24

10.1186/s12875-026-03217-5

Collaborative Care for Opioid Use Disorder and Mental Illness: The CLARO Randomized Clinical Trial.

Watkins KE, Osilla KC, McCullough CM, Griffin BA, Dopp AR, Becker K, Meredith LS, Carrejo V, Hindmarch GM, Mendon-Plasek S, Christensen J, Weir R, Kelly L, Pak L, Murray-Krezan C, Tarhuni L, Crowley C, Bilder A, Kalmin MM, Schoenbaum M, Komaromy M.

2025-12-29

10.1001/jamainternmed.2025.7036

Association between housing status and mental health and substance use severity among individuals with opioid use disorder and co-occurring depression and/or PTSD

Lauren J. Kelly, Grace Hindmarch, Katherine E. Watkins, Colleen McCullough, Beth Ann Griffin et al. (9 authors)

BMC Primary Care2025-08-081 citations

10.1186/s12875-025-02947-2

Interpersonal Violence and Mental Health, Drug use, and Treatment Utilization among Patients with Co-Occurring Opioid use and Mental Health Disorders

Grace Hindmarch, Lisa S. Meredith, Colleen McCullough, Beth Ann Griffin, Katherine E. Watkins

Chronic Stress2024-01-012 citations

10.1177/24705470241279335

Design of CLARO+ (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses, Plus): A randomized trial of collaborative care to decrease overdose and suicide risk among patients with co-occurring disorders

Karen Chan Osilla, Lisa S. Meredith, Beth Ann Griffin, Monique Martineau, Grace Hindmarch et al. (6 authors)

Contemporary Clinical Trials2023-07-162 citations

10.1016/j.cct.2023.107294

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders

Karen Chan Osilla, Alex R. Dopp, Katherine E. Watkins, Venice Ceballos, Brian Hurley et al. (9 authors)

Addiction Science & Clinical Practice2022-04-087 citations

10.1186/s13722-022-00302-9

Interventions

BEHAVIORALCollaborative 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Buprenorphine access	Assessed at 6 months after study entry.	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.
Post-traumatic Stress Disorder (PTSD) symptom severity	Assessed at 6 months after study entry.	Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.
Major Depressive Disorder (MDD) symptom severity	Assessed at 6 months after study entry.	Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.
Buprenorphine continuity of care	Assessed at 6 months after study entry.	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.

Secondary

Measure	Time frame	Description
Access to MDD and/or PTSD treatment	Assessed at 30 days and 180 days after study entry.	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.
Quality of care for MDD	Assessed at 6 months after study entry.	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.
Quality of care for PTSD	Assessed at 6 months after study entry.	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.
MDD remission	Assessed at 6 months after study entry	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.
MDD response	Assessed at 6 months after study entry.	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.
PTSD remission	Assessed at 6 months after study entry.	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.
PTSD response	Assessed at 6 months after study entry.	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.
Active suicidal ideation	Assessed at 6 months after study entry.	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.
Opioid use frequency	Assessed over 30 days after study entry.	Days of opioid use in the past 30 days from National Survey on Drug Use and Health. Obtained from patient survey.
Opioid overdose events	Assessed over the previous 3 months after study entry.	Opioid overdose events (at least 1 event) in the previous three months. Obtained from patient survey.
Physical health functioning	Assessed at 30 days after study entry	Physical health measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) physical health subscale.
Mental health functioning	Assessed at 30 days after study entry	Mental health functioning measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) mental health subscale.

Other

Measure	Time frame	Description
Drug use frequency	Assessed over 30 days after study entry.	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.
Opioid overdose risk behaviors	Assessed over 3 months after study entry.	Sum of 32-items in the Opioid Overdose Risk Assessment.
Alcohol use	Assessed over 3 months after study entry.	Sum of items (0-12) in the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months.
Stimulant use frequency	Assessed over 30 days after study entry.	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.
Opioid use severity	Assessed over 30 days after study entry.	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.
Demographics	Assessed at study entry.	Self-reported demographics on age, sex, race/ethnicity, educational attainment, and marital status.
Pain levels	Assessed over the previous 7 days at study entry and at 3 and 6 months after study entry	Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview
History of MOUD treatment	Asked about lifetime MOUD treatment; assessed at study entry	Assessed as a covariate; obtained from patient interview
Current MDD/PTSD treatment	Assessed over the previous 30 days at study entry	NSDUH items; assessed as a covariate; obtained from patient interview
Prior experience with a care coordinator	Assessed over the previous 12 months at study entry	Assessed as a covariate; obtained from patient interview
Homelessness	Assessed over the previous 3 months at study entry	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
Disability and impairment	Assessed over the previous 7 days at study entry	3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview
Clinician (care coordinator) communication	Assessed over the previous 3 months at 3 months after study entry	Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Ability to access treatment quickly	Assessed over the previous 3 months at 3 months after study entry	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Satisfaction with treatment	Assessed over the previous 3 months at 3 months after study entry	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Patient-care manager working alliance	Assessed over the previous 3 months at 3 months after study entry	Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview

Countries

United States

Outcome results

None listed