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

NCT04245423 | Completed DMC

• 2 other identifiers: UF1MH1219441UF1MH121944-01
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Mental Health Conditions

Keywords

Opioid-use disorder; Depression; Anxiety; Post-traumatic stress disorder; Collaborative Care

Outcome Measures

Primary Outcomes (5)

• Change in opioid use based on self-reported

  Modified Timeline Followback

  Baseline and monthly for 6 months

• Change in opioid use based on toxicology

  Urine Drug Screens

  Baseline and monthly for 6 months

• Change in psychiatric symptoms - Depression

  Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes

  Baseline and monthly for 6 months

• Change in psychiatric symptoms - Anxiety

  Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes

  Baseline and monthly for 6 months

• Change in psychiatric symptoms - Post-traumatic Stress Disorder

  Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); range is 0-80 with higher scores demonstrating worse outcomes

  Baseline and monthly for 6 months

Secondary Outcomes (4)

• Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)

  Baseline and monthly for 6 months

• Change in medication adherence

  Baseline and monthly for 6 months

• Treatment retention

  6 months

• Rate of Mortality

  6 months

Study Arms (3)

Augmented Usual Care (AUC)

ACTIVE COMPARATOR

If not already waivered, PCPs will be trained and waivered to treat OUD with medications. Almost all practices have hired mental health clinicians, equivalent to the care managers in the investigators' collaborative care model, to treat mild and moderate depression and anxiety. These clinicians typically are licensed clinical social workers; a few are nurses or psychologists. No care managers have received systematic training in treating patients with OUD. The clinicians will retain their role and continue to treat and monitor patients with mental health conditions in these practices. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD. Patients are informed that the primary care practice provides both OUD and mental health treatment and are referred back to their provider for referral or to schedule care. A list of available community resources are available to the patient.

Behavioral: Augmented Usual Care

Collaborative Care (CC)

EXPERIMENTAL

CC condition includes the following elements: 1. Personnel trained to assist with scheduling, reminders and referrals; 2. PCP trained and waivered to provide evidence-based pharmacotherapy for OUD; 3. Addictions psychiatrist with collaborative care expertise to provide treatment consultation and supervision in both OUD and mental health issues; 4. A care manager trained in evidence-based interventions for individuals with OUD and psychiatric disorders, who provides care in the primary care practice as part of the collaborative care team; 5. Measurement-guided care and treat-to-target practices, using validated measures of substance use, depression, anxiety as well as measures of adherence and side effects; 6. Electronic and in-person systematic communication regarding patient care among team members, facilitated by the electronic health record; and 7. Shared patient-provider decision making.

Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions

Collaborative Care + Certified Recovery Specialist (CC+)

EXPERIMENTAL

In addition to the collaborative care model described above, patients in the CC+ condition will have access to a Certified Recovery Specialist (CRS) to assist with treatment engagement and retention. A CRS is a person in the community who is in recovery and may share similar experiences and barriers that participants have faced. They will work with participants as a peer to help them coordinate information and needs with their providers. The CRS will take participants to their PCP appointments and any other appointments that they may have to help them engage and stay in care to remain healthy. They will also provide education and help participants work on their recovery goals. They will identify and support linkages to community resources and help participants identify barriers to full participation in their recovery and develop strategies to overcome those barriers.

Behavioral: Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists

Interventions

Collaborative Care for Opioid Use Disorders and Mental Health Conditions BEHAVIORAL

CC is delivered using the investigators' Foundations for Integrated Care model. The first line pharmacotherapy is buprenorphine-naloxone. The second line pharmacotherapy included is extended-release injectable naltrexone. Pharmacotherapy is accompanied by brief problem-solving therapy, cognitive-behavioral therapy, and/or motivational interviewing. The primary care physician, in consultation with the addictions psychiatrist and care manager, also will provide psychotropic medications for psychiatric disorders. In-person and telephone visits consist of the care manager carrying out intervention activities over 6 months. Visits are at baseline (90-minute intake appointment), home or office induction when in moderate opiate withdrawal if buprenorphine is prescribed, twice a week for two weeks with telephone calls in between visits, then weekly, and when stable once a month. There will be a final visit at 6 months. The intervention includes routine collection of urine drug screens.

Collaborative Care (CC)

Augmented Usual Care BEHAVIORAL

If not already waivered, PCPs will be trained and waivered to treat OUD with medications. All practices will have mental health clinicians to treat mild psychiatric disorders. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD.

Augmented Usual Care (AUC)

Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists BEHAVIORAL

This intervention includes the Collaborative Care Intervention plus Certified Recovery Specialist to assist with treatment engagement and retention.

Collaborative Care + Certified Recovery Specialist (CC+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older;
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Penn Center for Primary Care

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Harris RA, Campbell K, Calderbank T, Dooley P, Aspero H, Maginnis J, O'Donnell N, Coviello D, French R, Bao Y, Mandell DS, Bogner HR, Lowenstein M. Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. Healthc (Amst). 2022 Sep;10(3):100641. doi: 10.1016/j.hjdsi.2022.100641. Epub 2022 Jul 2.

  PMID: 35785613 DERIVED

• Harris RA, Mandell DS, Kampman KM, Bao Y, Campbell K, Cidav Z, Coviello DM, French R, Livesey C, Lowenstein M, Lynch KG, McKay JR, Oslin DW, Wolk CB, Bogner HR. Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol. Contemp Clin Trials. 2021 Apr;103:106325. doi: 10.1016/j.cct.2021.106325. Epub 2021 Feb 22.

  PMID: 33631356 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• David Mandell, ScD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kenneth E. Appel Professor and Director, Penn Center for Mental Health

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 28, 2020
• Study Start: December 15, 2020
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)