About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
Disqualifiers
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;
Trial design
Factorial
Treatments tested in this trial
Acceptance and commitment therapy
BehavioralIntervention 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).
Valera Smartphone Application
Other interventionFor 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.
Treatment as Usual
Other interventionTAU 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).
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain Interference
Change in Pain Interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associate with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Higher scores are indicative of more interference with daily life. Results will be summarized by study arm using basic descriptive statistics.
Illicit Opioid Use
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids or analgesics \[unprescribed\]. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Secondary outcomes
Psychological Flexibility
Psychological flexibility is measured using the Multidimensional Psychological Flexibility Inventory - Short (MPFI-S) flexibility subscale, which consists of 12 items. Responses range from 1 ("Never true") to 6 ("Always true"). There are two subscales measuring psychological flexibility and inflexibility across key areas. A global composite score for flexibility uses the first 12 answers and divides scores by 12 to obtain a mean score. Higher scores reflect higher levels of psychological flexibility.
Psychological Inflexibility
Psychological inflexibility is measured using the Multidimensional Psychological Flexibility Inventory - Short (MPFI-S) inflexibility scale, which consists of 12 items. Responses range from 1 ("Never true") to 6 ("Always true"). There are two subscales measuring psychological flexibility and inflexibility across key areas. A global composite score for inflexibility uses the last 12 answers and divides scores by 12 to obtain a mean score. Higher scores reflect higher levels of psychological inflexibility.
Psychological Flexibility Related to Substance Use
Psychological inflexibility related to substance use is measured using the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA), a self-report scale. The AAQ-SA assesses the degree to which individuals avoid or struggle with substance-related thoughts, urges, and emotions, and the extent to which these experiences interfere with values-consistent behavior over recent weeks. Items are rated on a 7-point Likert scale ranging from 1 ("Never true") to 7 ("Always true"). Several items are reverse scored so that item responses can be summed to yield a total score, with lower scores indicating greater psychological flexibility (i.e., less experiential avoidance) in the context of substance use.
Committed Action
Committed action is measured using the Committed Action Questionnaire (CAQ), an 18-item self-report scale. Each item assesses the degree to which individuals persist in values-directed actions in the face of discomfort over the past several weeks and is rated on a 7-point scale ranging from 0 ("Never true") to 6 ("Always true"). Item scores are summed to produce a total score ranging from 0 to 108, with higher scores indicating greater levels of committed action.
Sponsors and contacts
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Albert Einstein College of Medicine
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Weill Medical College of Cornell University
Collaborator
Wake Forest University Health Sciences
Collaborator
University of Miami
Collaborator
Valera Health
Collaborator
Tulane University
Collaborator