Project Summary
PCORI has identified treatment for opioid use disorder as an important research topic. Patients, clinicians, and others want to learn: Can counseling, support groups, and similar programs help patients who are getting medicine-based treatment for opioid use disorder? To help answer this question, PCORI launched an initiative in 2018 on Psychosocial Interventions with Office-Based Opioid Treatment (OBOT) for Opioid Use Disorder. The initiative funded this research project and others.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Opioid use disorder, or OUD, happens when people misuse, become addicted to, or take too many opioids at once. Doctors may use medicine to treat OUD. But many people stop taking their medicine, which increases their risk of using opioids again or taking too many opioids at once. Involving friends and family may help people stay on treatment for OUD.
In this study, the research team is testing a counseling program for people who support patients with OUD, including family members, spouses, and friends. The program is called Integrating Support Persons Into Recovery, or INSPIRE. INSPIRE draws from the Community Reinforcement and Family Training, or CRAFT, approach and teaches support people effective ways to help a person with OUD change their behavior. It also teaches ways for them to feel better themselves. The team wants to know if INSPIRE helps patients stay on OUD treatment and if it improves health outcomes for patients and their support people.
Who can this research help?
Results may help clinic leaders considering ways to help people with OUD and people who support them.
What is the research team doing?
The research team is recruiting 500 pairs of adults who are starting treatment for OUD and their support people. Patients are receiving treatment from 17 community health clinics in California.
The team is assigning the support people to receive either INSPIRE or the usual services available at clinics. INSPIRE consists of ten 90-minute in-person group sessions, led by two facilitators. The research team is interviewing patients and support people at the start of the study and again 3 and 12 months later. The team wants to see if INSPIRE helps patients keep using medicine to treat OUD and stop using opioids. In addition, the team is looking to see if INSPIRE improves depression and anxiety for patients and support people. Finally, the team wants to know if INSPIRE works better for some people than others, such as when a support person is a family member, spouse, or friend.
Patients, support people, clinic staff, psychologists, psychiatrists, and health insurers are helping to plan and conduct the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 500 adults ages 18 and older who are starting buprenorphine and their support person |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient buprenorphine retention Secondary: patient opioid and other substance use, patient and support person depression, patient and support person anxiety |
| 1-year follow-up for primary outcome |
COVID-19-Related Study
Testing a Group Counseling Program for People Who Support Patients with Opioid Use Disorder -- The eINSPIRE Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
In opioid use disorder, or OUD, people use opioids in ways that cause impairment and distress. One way to treat OUD is with medicine. Support people, including friends and family, can help patients stay on their OUD medicine. But during the COVID-19 pandemic, isolation and stress made it hard for support people to help patients stay on their treatment.
In this study, the research team compared two approaches to improve support people’s and patient’s mental health and support people’s efforts to help patients to stay on OUD medicine:
- A group telehealth program. The program included 10 weekly, one-hour group video sessions for support people. A trained counselor led sessions about OUD medicine, ways to help patients with OUD stay on treatment, and how support people can increase their social support.
- Usual care. Support people could use services such as counseling and primary care to support their mental health.
What were the results?
After three months, the two approaches didn’t differ in the percentage of patients staying on OUD medicine.
Support people in the group program reported less impairment from the patient’s OUD on their work, home, and social life than support people in usual care.
Compared with usual care, patients who had support people in the group program:
- Didn’t differ in their level of impairment from OUD
- Reported higher social support
The two groups didn’t differ in support people’s or patients’ depression, anxiety, or relationship strength and conflict.
Who was in the study?
The study included 100 pairs of patients with OUD and their support people. Support people could be patients’ partners, parents, adult children, or friends.
Of support people, 56 percent were White, 17 percent were more than one race, 10 percent were Hispanic or Latino, and 8 percent were Black. Also, 3 percent were Alaska Native or American Indian, 1 percent were Asian, 1 percent were Native Hawaiian, and 4 percent identified as another race. The average age was 48, and 80 percent were women. Patients received care from one of five community health clinics in California.
What did the research team do?
The research team assigned support people by chance to the group telehealth program or usual care. All patients continued receiving medicine to treat OUD.
At the start of the study and three months later, patients and support people completed surveys. Surveys asked about depression and anxiety symptoms, strength of relationships, conflict in relationships, social support, and harm from the patients’ OUD. The research team reviewed patients’ health records to assess OUD medicine use.
A panel of patients with OUD, support people, doctors, health insurers, and policy makers helped design the study.
What were the limits of the study?
Of support people assigned to the group telehealth program, 75 percent didn’t attend any sessions. Results may have differed if support people had attended more sessions.
How can people use the results?
Health clinics can consider the results when working to help patients stay on OUD medicine and improve support people’s mental health.
| PCORI identified treatment for opioid use disorder as an important research topic. Patients, clinicians, and others wanted to learn: Can counseling, support groups, and similar programs help patients who are getting medicine-based treatment for opioid use disorder? To help answer this question, PCORI launched an initiative in 2018 on Psychosocial Interventions with Office-Based Opioid Treatment (OBOT) for Opioid Use Disorder. The initiative funded this research project and others. |
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
During the COVID-19 pandemic, patients with opioid use disorder (OUD) and their support people (SPs) experienced increased isolation and stress levels, which made it more challenging for patients to maintain buprenorphine treatment.
Objective
To compare the effectiveness of a group telehealth program for SPs of patients with OUD versus usual care in improving patient buprenorphine retention and mental health outcomes among patients and SPs
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 100 patient–SP pairs, which included 100 patients ages 18 and older who were receiving buprenorphine treatment for OUD at a community clinic and 100 SPs, including family members, spouses, and friends who had contact with the patient at least 3 times a week and were not actively using opioids |
| Outcomes | Primary: patients’ buprenorphine retention (defined as a patient having active buprenorphine prescriptions for 90 days since enrollment, with no more than a 7-day lapse between prescriptions); patients’ and SPs’ depressive symptoms; patients’ and SPs’ anxiety symptoms; patient- and SP-reported functional impairment associated with patients’ OUD across work, school, home, and social life
Secondary: patients’ and SPs’ relationship cohesion and conflict, and perceived social support |
| Data Collection Timeframe | November 2020–December 2022 |
This randomized controlled trial compared the effectiveness of a group telehealth program for SPs versus usual care in improving patient buprenorphine retention and mental health outcomes among patients and SPs.
Researchers randomized SPs to receive either:
- The eINSPIRE program. The program included 10 group sessions delivered via telehealth. A trained facilitator led each 60-minute session and mailed worksheets for home use. Sessions focused on improving SP communication strategies, using positive reinforcement and rewards with the patient, increasing social support for the SP, and providing education about OUD and buprenorphine.
- Usual care. SPs could choose to participate in individual behavioral health counseling, psychoeducation groups, or standard primary care services.
All patients continued receiving buprenorphine from their community clinic via telehealth or in-person visits.
The study included 100 dyads of patients with OUD receiving buprenorphine and their SPs. Patients received care at one of five community clinics in California. Of SPs, 56% were White, 17% were more than one race, 10% were Hispanic or Latino, 8% were Black, 3% were Alaska Native or American Indian, 1% were Asian, 1% were Native Hawaiian, and 4% identified as another race. The average age was 48, and 80% were female.
At baseline and three months later, both patients and SPs completed surveys on depression, anxiety, relationship cohesion, conflict, social support, and impairment related to the patients’ OUD. At three months, researchers reviewed medical records to assess patient buprenorphine retention.
A panel of patients with OUD, SPs, clinicians, health insurers, and policy makers helped design the study.
Results
After three months, 68% of patients with SPs in the eINSPIRE program were retained on buprenorphine compared with 53% of patients with SPs in usual care; this difference was not statistically significant.
More SPs in the eINSPIRE program reported reductions in impairment associated with the patient’s OUD compared with SPs in usual care (p=0.011); patients with SPs in eINSPIRE versus usual care did not differ significantly in their level of impairment. More patients with SPs in eINSPIRE reported increases in social support compared with patients with SPs in usual care (p=0.004).
The two groups did not differ significantly in all other outcomes.
Limitations
About 75% of SPs did not attend any program sessions. Results may have differed with higher attendance.
Conclusions and Relevance
In this study, compared with usual care, the eINSPIRE program for SPs did not significantly improve buprenorphine retention among patients with OUD. SPs in the eINSPIRE program did have reductions in impairment associated with the patient’s OUD, but no improvement was seen in other mental health outcomes.
| PCORI identified treatment for opioid use disorder as an important research topic. Patients, clinicians, and others wanted to learn: Can counseling, support groups, and similar programs help patients who are getting medicine-based treatment for opioid use disorder? To help answer this question, PCORI launched an initiative in 2018 on Psychosocial Interventions with Office-Based Opioid Treatment (OBOT) for Opioid Use Disorder. The initiative funded this research project and others. |
Peer Review Summary
The Peer-Review Summary for this COVID-19 study will be posted here soon.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by July 2024.