RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-02
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05039554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years old or older;
  2. 2. English or Spanish proficiency;
  3. 3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
  4. 4. 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.
  1. 1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);
  2. 2. psychotropic medication changes within the past three months prior to enrollment;
  3. 3. CP related to malignancy;
  4. 4. received ACT or similar therapeutic intervention in the past;
  5. 5. initiated psychotherapy within the past three months;
  6. 6. neurocognitive conditions that may prevent participants from accessing telehealth services;
  7. 7. current use of a smartphone health platform similar to the Valera app;
  8. 8. are unable or unwilling to provide signed consent for participation.

Contacts and Locations

Study Contact

Hector Perez, MD
CONTACT
718-683-0213
heperez@montefiore.org
Joanna Starrels, MD
CONTACT
joanna.starrels@einsteinmed.edu

Principal Investigator

Hector Perez, MD
PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine Montefiore Medical Center
Tiffany Liu, MD
STUDY_DIRECTOR
Montefiore
Brianna Norton, DO
STUDY_DIRECTOR
Montefiore

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Albert Einstein College of Medicine

  • Hector Perez, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine Montefiore Medical Center
  • Tiffany Liu, MD, STUDY_DIRECTOR, Montefiore
  • Brianna Norton, DO, STUDY_DIRECTOR, Montefiore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-02
Study Completion Date2027-10

Study Record Updates

Study Start Date2023-02-02
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid-use Disorder
  • Chronic Pain