Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

Study Overview
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Brief Summary
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The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.

Detailed Description
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Chronic pain (CP) and opioid use disorder (OUD) are leading causes of morbidity and mortality in the United States. Despite being commonly comorbid, there is a striking lack of integrated treatments accessible to people in need. This is particularly true for Black and Hispanic individuals living and seeking care in under-resourced settings like The Bronx, NY, one of the poorest and most racially diverse counties in the U.S. Submitted in response to the HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) RFA-DA-21-030, the overall goal of this proposal is to create the IMPOWR Research Center at Montefiore/Einstein (IMPOWR-ME), in the high-impact county of The Bronx NY. IMPOWR-ME is a synergistic multidisciplinary research center that leverages exceptional research infrastructure in CP and OUD and existing relationships with people living with CP and OUD, advocates, policymakers and payers, and health system stakeholders. The aims of IMPOWR-ME are to: 1) create a robust and sustainable research infrastructure to rigorously test and disseminate integrated and cost-effective evidence-based practices for people with CP and OUD; 2) partner with people with lived experience with CP, OUD, or both, and diverse stakeholders in all stages of the research; and 3) provide opportunities for multidisciplinary early stage investigators to become independent researchers focusing on CP and OUD. This innovative hybrid type 1 effectiveness-implementation trial is proposed to rigorously examine multi-modal evidence-based practices in diverse health care settings and populations of people with comorbid CP and OUD. Specifically, the investigators propose a 2x2 factorial trial to test Acceptance and Commitment Therapy and a care management smartphone app for individuals in primary-care based buprenorphine treatment. Participants will have both CP and OUD or opioid misuse, and specific aims will examine CP, OUD, implementation, and cost-effectiveness outcomes; additional patient-centered outcomes will be driven by people with lived experience. This project improves access to care for Black and Hispanic individuals in under-resourced settings by bringing integrated treatment of CP and OUD to them, and the interventions have high potential for dissemination and sustainability. An innovative program for pilot studies achieves a dual aim of catalyzing stakeholder-driven research and training early stage and new investigators. An exceptional team of investigators and clinical experts focused on CP and OUD, a longstanding history of collaboration with stakeholders and people with lived experience, and a high-impact population make Montefiore-Einstein an ideal site for an IMPOWR research center.

Official Title
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Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment

Conditions
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Opioid-use Disorder, Chronic Pain

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy
* Other: Valera Smartphone Application
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older; English or Spanish proficiency; receiving BUP treatment for OUD in the Montefiore BUP Treatment Network for at least 1 month (thus a stabilized BUP dose); and CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity scale (PEG). Comorbid psychiatric conditions and use of psychotropic medications will be allowed. Exclusion Criteria: Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis); psychotropic medication changes within the past three months prior to enrollment; CP related to malignancy; received ACT or similar therapeutic intervention in the past; initiated psychotherapy within the past three months; neurocognitive conditions that may prevent participants from accessing telehealth services; current use of a smartphone health platform similar to the Valera app; are unable or unwilling to provide signed consent for participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acceptance and commitment therapy (ACT) alone<br>Participants randomized to this cohort will receive only acceptance and commitment therapy. | Behavioral: Acceptance and commitment therapy<br>* Intervention will be provided over 12 weeks with weekly 1-hour sessions using a group format with the overall goal to foster psychological flexibility. ACT will assist participants to notice their internal triggers; abandon their attempts to manage these triggers via active avoidance (suppression or other control-based strategies including opioid or other substance use) and to make commitments to engage in behaviors consistent with their chosen values or goals (rather than allowing negative thoughts, feelings, or pain symptoms to dictate behavior).<br>* Other names: ACT;|
| Active Comparator: Valera smartphone application (app) alone<br>Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary. | Other: Valera Smartphone Application<br>* For those randomized to a cohort with the Valera app, the app (and cellphones if necessary) will be provided. The app is HIPAA compliant and IRB approved. It consists of 2 components: a participant-facing Smartphone Application and a corresponding online Care Manager Dashboard. Smartphones and internet access will be provided as needed for the 12-week study duration.<br>|
| Experimental: ACT + Valera app<br>Participants randomized to this cohort will receive both ACT and the Valera app (and a smartphone with network connectivity if necessary). | Behavioral: Acceptance and commitment therapy<br>* Intervention will be provided over 12 weeks with weekly 1-hour sessions using a group format with the overall goal to foster psychological flexibility. ACT will assist participants to notice their internal triggers; abandon their attempts to manage these triggers via active avoidance (suppression or other control-based strategies including opioid or other substance use) and to make commitments to engage in behaviors consistent with their chosen values or goals (rather than allowing negative thoughts, feelings, or pain symptoms to dictate behavior).<br>* Other names: ACT;Other: Valera Smartphone Application<br>* For those randomized to a cohort with the Valera app, the app (and cellphones if necessary) will be provided. The app is HIPAA compliant and IRB approved. It consists of 2 components: a participant-facing Smartphone Application and a corresponding online Care Manager Dashboard. Smartphones and internet access will be provided as needed for the 12-week study duration.<br>|
| Placebo Comparator: treatment as usual (TAU)<br>Participants randomized to this cohort will not receive any experimental treatments. | Other: Treatment as Usual<br>* TAU for BUP treatment typically consists of regularly scheduled visits every 1-2 months with primary care physicians and/or nurse care managers in Montefiore primary care settings. During these 15-min follow up visits, providers typically inquire about opioid and other substance use, opioid craving, symptoms of opioid withdrawal, and risk of relapse. In addition, at each visit, urine toxicology tests are conducted and providers review results of prior urine toxicology tests with patients. If opioid or other substance use is ongoing, typically providers will intensify treatment, including increasing the frequency of visits, referring to social workers or mental health providers, recommending self-help groups, and/or recommending outpatient drug treatment programs (e.g., individual and group counseling).<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference | The primary outcome for pain will be pain-related functional interference, assessed with the Brief Pain Inventory (BPI), pain interference subscale, a nine-item measure that assesses pain related interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The total score has demonstrated reliability (e.g., Cronbach's Alpha = 0.86) and validity with chronic pain patients. | 24 weeks | 
| Opioid Use | Opioid use will be measures by the Addiction Severity Index (ASI), which provides an assessment of drug use in the past 30 days, as done in our other studies. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Report Outcome Measurement | Quality of life based on Physical, Emotional, and Substance Use | 24 weeks | 
| Multidimensional Psychological Flexibility Inventory (MPFI) | psychological flexibility of behavior, feelings and emotions | 24 weeks | 
| CHRONIC PAIN ACCEPTANCE QUESTIONNAIRE | Feelings of pain and whether they can be accepted or tolerated | 24 weeks | 
| AAQ-SA | Substance use urges and psychological flexibility when it comes to misuse | 24 weeks | 
| Mood Symptoms | Mood symptoms will be assessed by the Patient Health Questionnaire Beck Depression Inventory | 24 weeks | 
| Anxiety Symptoms | Anxiety symptoms will be assessed by the Beck Anxiety Index | 24 weeks | 
| Pain catastrophizing | Pain catastrophizing will be assessed via the Pain Catastrophizing Scale. | 24 weeks | 
| Trauma | Trauma will be assessed for via the Life Events Checklist. | 24 weeks | 
| Opioid craving | Opioid craving will be assessed for via the Medication Craving Scale. | 24 weeks | 
| Substance Use | Substance use other than opioid use will be assessed via the ASI | 24 weeks | 
| Alcohol Use | Audit C | 24 weeks | 
| Substance use | urine toxicology tests. | 24 weeks | 
| Anhedonia | Anhedonia will be assessed via the Snaith-Hamilton Pleasure Scale (SHAPS). | 24 weeks | 
| Sleep | Sleep will be assessed via PROMIS Sleep Disturbance 6a + Sleep Duration Question. | 24 weeks | 
| Perceived Stress | NIH Toolbox Perceived Stress Fixed Form 18+. | 24 weeks | 
| Stress | Stress will be assessed via the Urban Life Stress Scale. | 24 weeks | 
| Stigma & discrimination | Stigma and discrimination will be assessed via the Perceived discrimination: Everyday discrimination scale. | 24 weeks | 
| Suicidality | Suicidality will be assessed via the Columbia Suicide Severity Rating Scale. CSSR-S | 24 weeks |