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

Conditions

• Chronic Pain
• Opioid-use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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
  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
  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).

Study Details

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.

Key Dates

Start date

Feb 2, 2023

Status verified

May 2026

Primary completion

Apr 27, 2027

Completion

Apr 27, 2027

Study Design

Enrollment

127 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• 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.
• 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).
• Placebo Comparator: treatment as usual (TAU)
  Participants randomized to this cohort will not receive any experimental treatments.

Primary Outcome Measure

Change in Pain Interference [ Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks ]

Central Contacts

• Hector Perez, MD
  718-920-5756
  [email protected]
• Joanna Starrels, MD
  [email protected]

Locations (1)

Find similar trials in The Bronx, NY

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