Clinical trial NCT05039554: Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
Official title: Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Chronic Pain
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years old or older;
2. English or Spanish proficiency;
3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
4. 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:

1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);
2. psychotropic medication changes within the past three months prior to enrollment;
3. CP related to malignancy;
4. received ACT or similar therapeutic intervention in the past;
5. initiated psychotherapy within the past three months;
6. neurocognitive conditions that may prevent participants from accessing telehealth services;
7. current use of a smartphone health platform similar to the Valera app;
8. are unable or unwilling to provide signed consent for participation.

Primary outcomes:
measure: Pain interference
timeFrame: Baseline, 30 days, 12 weeks, 36 weeks
measure: Opioid Use
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Secondary outcomes:
measure: Patient Report Outcome Measurement
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks
measure: Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: CHRONIC PAIN ACCEPTANCE QUESTIONNAIRE
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: AAQ-SA
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Mood Symptoms
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Anxiety Symptoms
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Pain catastrophizing
timeFrame: Baseline, 12 weeks, 36 weeks
measure: Trauma
timeFrame: Baseline and 24 weeks
measure: Opioid craving
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Substance Use
timeFrame: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Alcohol Use
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Substance use
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Anhedonia
timeFrame: Baseline, 24 weeks, 36 weeks
measure: Sleep
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks
measure: Perceived Stress
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks
measure: Stress
timeFrame: Baseline and 24 weeks
measure: Stigma & discrimination
timeFrame: Baseline
measure: Suicidality
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
measure: Satisfaction with Therapy
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Hector Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore
name: Tiffany Liu, MD
role: STUDY_DIRECTOR
affiliation: Montefiore
name: Brianna Norton, DO
role: STUDY_DIRECTOR
References: