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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Acceptance and commitment therapy; Other: Valera Smartphone Application; Other: Treatment as Usual

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, New York, 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) (Request For Applications ID: 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 New York. 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.

• Study Type: Interventional
• Enrollment (Estimated): 127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Starrels, MD; Email: joanna.starrels@einsteinmed.edu
• Study Contact Backup: Name: Hector Perez, MD; Phone Number: 718-920-5756; Email: heperez@montefiore.org

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Beth Hribar, MPP; Phone Number: 608-335-3481; Email: mary.hribar@einsteinmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (PEG) scale). 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Valera smartphone application (app) alone; Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary.	Other: Valera 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.
Placebo Comparator: treatment as usual (TAU); Participants randomized to this cohort will not receive any experimental treatments.	Other: Treatment 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).; Other Names: TAU
Experimental: ACT + Valera app; Participants randomized to this cohort will receive both acceptance and commitment therapy (ACT) and the Valera app (and a smartphone with network connectivity if necessary).	Behavioral: Acceptance 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).; Other Names: ACT; Other: Valera 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
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.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Pain Acceptance	Pain acceptance is measured using a 20-item scale called the Chronic Pain Acceptance Questionnaire--Revised (CPAQ-R). This is designed to measure acceptance of pain. It is measured on a scale of 0 ("Never true") to 6 ("Always true"). There are two subscales: (1) activity engagement, (2) pain willingness. Total score for pain acceptance is derived from mean scores on each of the subscales. Higher scores indicate higher levels of acceptance.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Pain Catastrophizing	Pain catastrophizing is assessed via the 6-item Pain Catastrophizing Scale (PCS-6). The PCS-6 is a shortened version of the full 13-item Pain Catastrophizing Scale, designed to assess pain-related catastrophic thinking. Each items assesses maladaptive, cognitive, and emotional responses to pain experiences. Responses to items 4, 5, 6, 10, 11, and 13 from the original 13 item scale are rated on a 5-point scale ranging from 0 ("Not al all") to 4 ("All the time"). Item scores are summed to produce a total score ranging from 0-24, with higher scores indicating greater levels of pain catastrophizing. Scores will be summarized by study arm using basic descriptive statistics.	Baseline, 12 weeks, 36 weeks
Change in Pain Intensity	Change in pain intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine," such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Heroin Use	Heroin use will be defined by self-reported heroin use days of the past 30 days using an item from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Fentanyl Use	Fentanyl use will be defined by self-reported fentanyl use days of the past 30 days that is not prescribed, using items from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Unprescribed Prescription Opioid Analgesic Use	Prescription opioid analgesic use will be defined by self-reported number of days of prescription opioid analgesic use that is not prescribed, over the past 30 days, using items from a modified Addiction Severity Index questionnaire. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Heatlh Related Quality of Life (HRQoL)	HRQoL will be assessed using a utility score from the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) scoring system. PROPr summarizes several PROMIS domains into a single, preference-based score. PROPr is a health utility score which aggregates scores from 7 PROMIS domains: Cognitive Function/Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. PROPr scores are calculated using a multiplicative multiattribute utility function that combines the individual PROMIS domain scores into a single score. The PROPr score is expressed as a health utility index value on a scale between 0 (the utility of being dead) and 1 (utility of full health) such that higher scores are indicative of better perceived overall health utility. Scores will be summarized by study arm using basic descriptive statistics.	Baseline, 12 weeks, 24 weeks, and 36 weeks
Global Impression of Change	Global Impression of change from the beginning of the study will be evaluated using the Patient Global Impression of Change (PGIC) assessment. The PGIC consists of a single item which asks the participant "Since the start of the study (treatment), my overall pain is..." and asks the participant to rate their pain on a 7-point Likert scale ranging from 0 ("Very much improved") to 6 ("Very much worse"), such that lower scores are associated with an overall impression of improvement since the start of the study. Results will be summarized by study arm using basic descriptive statistics.	12 weeks and 36 weeks
Depressive Symptoms	Depressive symptoms are measured using the Beck Depression Inventory (BDI), a 21-item self-report scale. Each item assesses the severity of a depressive symptom experienced over the past two weeks and is scored on a 4-point scale ranging from 0 ("Symptom not present") to 3 ("Severe symptom"). Item scores are summed to produce a total score ranging from 0 to 63, with higher scores indicating greater severity of depressive symptoms. Scores will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Anxiety Symptoms	Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI), a 21-item self-report scale. Each item assesses the severity of common anxiety symptoms experienced over the past week and is scored on a 4-point scale ranging from 0 ("Not at all") to 3 ("Severely; it bothered me a lot"). Item scores are summed to produce a total score ranging from 0 to 63, with higher scores indicating greater severity of anxiety symptoms. Scores will be summarized by study arm using basic descriptive statistics.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Positive Urine for Non-prescribed Opioids	Positive urine for non-prescribed opioids will be assessed using point of care urine drug testing. Results of the test will be reported using a dichotomous variable ("Yes"/"No") where "Yes" is is indicated by positive oxycodone, fentanyl, or other opiates that were not indicated by participant as prescribed.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Anhedonia	Anhedonia will be assessed via the Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale. Each item assesses the ability to experience pleasure over the past few days and is rated on a 4-point scale consisting of "Strongly disagree," "Disagree", "Agree," or "Strongly agree". For scoring, responses will be dichotomized such that "Strongly disagree" and "Disagree" are scored as 1 point and "Strongly agree" and "Agree" are scored as 0 points. Scores are summed to yield a total score ranging from 0 to 14. Higher total scores indicate greater levels of anhedonia.	Baseline, 24 weeks, 36 weeks
Psychiatric Diagnoses	Psychiatric diagnoses are assessed using the Mini International Neuropsychiatric Interview (MINI), a structured diagnostic interview based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. The MINI is administered by trained study personnel to determine the presence or absence of current psychiatric disorders. Diagnoses are assessed at multiple time points to evaluate changes in diagnostic status over the course of the study. The total number of diagnoses at each timepoint will be reported. A higher number reflects higher burden of psychiatric disease.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Retention with Buprenorphine	Retention with buprenorphine will be measured by a dichotomous measure of whether a buprenorphine prescription occurred within 1 week of the time of a study visit. This is measured using pharmacy data obtained through I-stop, a NY State controlled substance monitoring program. Results will be summarized by study arm.	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Satisfaction with ACT	For participants enrolled into the ACT arm, satisfaction with ACT is measured using the Satisfaction With Therapy Scale (STS), a 14-item self-report questionnaire. The scale assesses participants' satisfaction with various aspects of their therapeutic experience. Each item is rated on a 5-point Likert scale ranging from 1 to 5, and item responses are summed to yield a total score ranging from 14-70. Higher total scores indicate greater satisfaction with ACT.	12 weeks
Satisfaction with Valera	For participants enrolled into one of the Valera smartphone application arms, satisfaction with Valera is measured is measured using a novel scale measuring overall satisfaction along with satisfaction with three different components: (1) Educational articles, (2) Appointment Reminders, and (3) Messaging Care Team. Each is measured along a Likert-type scale from 1-5, with higher scores reflecting higher satisfaction or usefulness, of Valera.	12 weeks
Valera Engagement with Articles	For participants enrolled into one of the Valera smartphone application arms, Valera Engagement with articles is a dichotomous measure assessing whether participants opened up each of 24 articles sent to participants twice weekly across the 12 week intervention. Each measure is measured as "Yes" or "No." Total engagement will be reflected as a percentage of total yes answers over the 24 articles. Higher percentages reflect higher engagement with articles.	12 weeks
ACT Attendance	For participants enrolled into the ACT arm, ACT attendance is a measure of attendance of each of 12 ACT sessions. These will be reported as percentages. Higher percentages indicates higher attendance.	12 weeks

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA); University of Miami; Weill Medical College of Cornell University; Wake Forest University Health Sciences; Tulane University; Valera Health
• Investigators: Principal Investigator: Hector Perez, MD, Albert Einstein College of Medicine Montefiore Medical Center

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Chronic Pain; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy; Therapeutics
• Other Study ID Numbers: 2021-13325; RM1DA055437 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No