The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions

  • End date
    May 29, 2024
  • participants needed
  • sponsor
    University of Pennsylvania
Updated on 29 January 2021


Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety or post-traumatic stress disorder (PTSD) in primary care. We also will examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models.


This research aims to refine and rigorously test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety disorder, or post-traumatic stress disorder (PTSD) in primary care. The investigators will also examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models. The primary aims of this proposal are: (1) Rapidly prototype and test our collaborative care models to optimize them for implementation at the University of Pennsylvania Health System (UPHS) primary care clinics for the treatment of individuals with co-occurring mental health problems and opioid use disorder (OUD); (2) Conduct a randomized clinical trial (RCT) among 1,185 primary care patients aged 18 years and older with OUD and depression, anxiety or PTSD. Patients will be randomized to one of three conditions:

  1. Augmented Usual Care (AUC), which consists of a primary care physician (PCP) waivered to prescribe buprenorphine, a mental health care manager, and an addiction psychiatrist to consult on Medication-Assisted Treatment (MAT); b) Collaborative Care (CC), which consists of a waivered PCP, a mental health care manager who receives OUD training, and a psychiatrist who provides telephonic consultation for OUD and mental health; or c) Collaborative Care Plus (CC+), which consists of all the elements of CC, plus a Certified Recovery Specialist (CRS) to help with patient engagement in treatment and retention in care;

(3) Measure clinician- level factors associated with implementation of each component and metrics of fidelity and reach, our primary implementation outcomes of interest; and (4) Assess the costs to primary care practices of implementing and delivering AUC, CC and CC+ and the change in total healthcare costs associated with the implementation. Successful completion of the proposed study will provide definitive evidence regarding the most parsimonious set of elements of integrated collaborative care required to maximize outcomes for individuals with OUD and psychiatric disorders.

Condition Opioid Use Disorder, Mental Health Conditions
Treatment Collaborative Care for Opioid Use Disorders and Mental Health Conditions, Augmented Usual Care, Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists
Clinical Study IdentifierNCT04245423
SponsorUniversity of Pennsylvania
Last Modified on29 January 2021


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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Mental Health Conditions or Opioid Use Disorder?
18 years and older
a diagnosis of opioid use disorder
a positive urine drug screen for opioids or self-report of opioid use within the last 30 days
agree to receive medication for opioid use disorder at the primary care site (the first line pharmacotherapy is buprenorphine-naloxone and the second line pharmacotherapy will include extended-release injectable naltrexone)
meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD
able to communicate in English; and
willing to give informed consent

Exclusion Criteria

acutely suicidal and needs immediate hospitalization, manic or psychotic (patients will not be randomized and PI or study physician covering for PI will be notified immediately); and
lack of a phone
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