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

160 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

Inclusion Criteria4

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.

Exclusion Criteria8

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.

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 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.

OTHERTreatment as Usual

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).