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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Acceptance and commitment therapy

    Behavioral

    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).

  • Valera Smartphone Application

    Other intervention

    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.

  • Treatment as Usual

    Other intervention

    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).

Treatment groups

127 Participants
are divided into 3 treatment groups
Group A: Valera smartphone application (app) aloneActive comparator 1 intervention
Group B: ACT + Valera appExperimental treatment 2 interventions
Group C: treatment as usual (TAU)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
2

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
2

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
3

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
4

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.

Time frame
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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