RecruitingNot ApplicableNCT05039554

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

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

Sponsor

Albert Einstein College of Medicine

Enrollment

123 participants

Start Date

Feb 2, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Opioid-use Disorder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether Acceptance and Commitment Therapy (ACT) — a type of mindfulness-based talk therapy — combined with a care management smartphone app can help people in opioid use disorder (OUD) treatment who also have chronic pain manage their pain better while staying on their buprenorphine medication. **You may be eligible if...** - You are 18 or older - You speak English or Spanish - You are currently being treated with buprenorphine for opioid use disorder for at least 14 days - You have moderate to severe chronic pain (scoring 4 or more on the PEG pain scale) **You may NOT be eligible if...** - You are experiencing an acute psychiatric crisis (active mania, suicidal thoughts, psychosis) - Your psychiatric medications were changed in the past 3 months - Your chronic pain is caused by cancer - You have already received ACT or similar therapy - You started psychotherapy in the past 3 months - You have a cognitive condition preventing telehealth access - You are already using a similar health app Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance and commitment therapy

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).

OTHERValera Smartphone Application

For those randomized to a cohort with the Valera app, the app (and cellphones if necessary) will be provided. The app is Health Insurance Portability and Accountability Act (HIPAA) compliant and Institutional Review Board (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.

OTHERTreatment as Usual

TAU for Buprenorphine (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).