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

Not Applicable

Active, not recruiting

• Conditions: Opioid-use Disorder; Mental Health Conditions

• Registration Number: NCT04245423
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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:

a) 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.

Study Timeline

• Study First Submitted: 2020-01-25
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Study Start: 2020-12-15
• Primary Completion: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

1. 18 years and older;
2. a diagnosis of opioid use disorder using DSM-5 criteria within the last 12 months OR have taken medication for opioid use disorder (MOUD) within the last 12 months;
3. 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);
4. meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD;
5. able to communicate in English; and
6. willing to give informed consent.

Exclusion Criteria

1. 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
2. lack of a phone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in opioid use based on toxicology	Baseline and monthly for 6 months	Urine Drug Screens
Change in opioid use based on self-reported	Baseline and monthly for 6 months	Modified Timeline Followback
Change in psychiatric symptoms - Depression	Baseline and monthly for 6 months	Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes
Change in psychiatric symptoms - Anxiety	Baseline and monthly for 6 months	Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes
Change in psychiatric symptoms - Post-traumatic Stress Disorder	Baseline and monthly for 6 months	Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); range is 0-80 with higher scores demonstrating worse outcomes

Secondary Outcome Measures

Name	Time	Method
Change in medication adherence	Baseline and monthly for 6 months	Self-report
Rate of Mortality	6 months	Assessed through death records
Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)	Baseline and monthly for 6 months	Modified Timeline Followback
Treatment retention	6 months	Measured as the time to dropout (from both OUD and mental health treatment using clinic records)

Trial Locations

Locations (1)

Penn Center for Primary Care; 🇺🇸 Philadelphia, Pennsylvania, United States