Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
- Conditions
- Chronic PainOpioid-use Disorder
- Interventions
- Other: Treatment as UsualBehavioral: Acceptance and commitment therapyOther: Valera Smartphone Application
- Registration Number
- NCT05039554
- Lead Sponsor
- Albert Einstein College of Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 18 years old or older;
- English or Spanish proficiency;
- receiving BUP treatment for OUD for at least 14 days (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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description treatment as usual (TAU) Treatment as Usual Participants randomized to this cohort will not receive any experimental treatments. acceptance and commitment therapy (ACT) alone Acceptance and commitment therapy Participants randomized to this cohort will receive only acceptance and commitment therapy. ACT + Valera app Acceptance and commitment therapy Participants randomized to this cohort will receive both ACT and the Valera app (and a smartphone with network connectivity if necessary). Valera smartphone application (app) alone Valera Smartphone Application Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary. ACT + Valera app Valera Smartphone Application Participants randomized to this cohort will receive both ACT and the Valera app (and a smartphone with network connectivity if necessary).
- Primary Outcome Measures
Name Time Method Pain interference Baseline, 30 days, 12 weeks, 36 weeks 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.
Opioid Use Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks 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.
- Secondary Outcome Measures
Name Time Method Suicidality Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks Suicidality will be assessed via the Columbia Suicide Severity Rating Scale. CSSR-S
Stigma & discrimination Baseline Stigma and discrimination will be assessed via the Perceived discrimination: Everyday discrimination scale.
Patient Report Outcome Measurement Baseline, 12 weeks, 24 weeks, 36 weeks Quality of life based on Physical, Emotional, and Substance Use
Multidimensional Psychological Flexibility Inventory (MPFI) Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks psychological flexibility of behavior, feelings and emotions
CHRONIC PAIN ACCEPTANCE QUESTIONNAIRE Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks Feelings of pain and whether they can be accepted or tolerated
AAQ-SA Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks Substance use urges and psychological flexibility when it comes to misuse
Mood Symptoms Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks Mood symptoms will be assessed by the Patient Health Questionnaire Beck Depression Inventory
Anxiety Symptoms Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks Anxiety symptoms will be assessed by the Beck Anxiety Index
Pain catastrophizing Baseline, 12 weeks, 36 weeks Pain catastrophizing will be assessed via the Pain Catastrophizing Scale.
Trauma Baseline and 24 weeks Trauma will be assessed for via the Life Events Checklist.
Opioid craving Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks Opioid craving will be assessed for via the Medication Craving Scale.
Substance Use Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks Substance use other than opioid use will be assessed via the ASI
Alcohol Use Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks Audit C
Substance use Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks urine toxicology tests.
Anhedonia Baseline, 24 weeks, 36 weeks Anhedonia will be assessed via the Snaith-Hamilton Pleasure Scale (SHAPS).
Sleep Baseline, 12 weeks, 24 weeks, 36 weeks Sleep will be assessed via PROMIS Sleep Disturbance 6a + Sleep Duration Question.
Perceived Stress Baseline, 12 weeks, 24 weeks, 36 weeks NIH Toolbox Perceived Stress Fixed Form 18+.
Stress Baseline and 24 weeks Stress will be assessed via the Urban Life Stress Scale.
Satisfaction with Therapy 12 weeks Satisfaction with therapy will be assessed by administration of a 13-item 'Satisfaction With Therapy Scale Revised' questionnaire. Responses to the items on the questionnaire will assess the participants' agreement to the various statements that best describe the ACT therapy received over the past 12 weeks based on a 5 point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree") for an overall possible score of 13-65 with higher scores denoting increased satisfaction. Group scores will be summarized by study arm using basic descriptive statistics.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States