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

NCT05039554 | Recruiting DMC

• 2 other identifiers: 2021-13325RM1DA055437
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Psychological Flexibility

  Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

• Psychological Inflexibility

  Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

• Psychological Flexibility Related to Substance Use

  Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

• Committed Action

  Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

• Pain Acceptance

  Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks

Study Arms (3)

Valera smartphone application (app) alone

ACTIVE COMPARATOR

Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary.

Other: Valera Smartphone Application

ACT + Valera app

EXPERIMENTAL

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; Other: Valera Smartphone Application

treatment as usual (TAU)

PLACEBO COMPARATOR

Participants randomized to this cohort will not receive any experimental treatments.

Other: Treatment as Usual

Interventions

Valera Smartphone Application OTHER

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.

ACT + Valera app; Valera smartphone application (app) alone

Treatment as Usual OTHER

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).

Also known as: TAU

treatment as usual (TAU)

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).

Also known as: ACT

ACT + Valera app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Miami: collaborator
• Valera Health: collaborator
• Tulane University: collaborator
• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

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MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hector Perez, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hector Perez, MD

CONTACT

718-920-5756; heperez@montefiore.org

Joanna Starrels, MD

CONTACT

joanna.starrels@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 9, 2021
• Study Start: February 2, 2023
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)