Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 scale (PEG). Comorbid psychiatric conditions and use of psychotropic medications will be allowed.

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Hector Perez, MD
heperez@montefiore.org
718-683-0213
Backup
Joanna Starrels, MD
joanna.starrels@einsteinmed.edu
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2027-04
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov