RECRUITING

Stepped Care for Patients to Optimize Whole Recovery

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

This is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise \[Wii Fit, Tai Chi\] and stress reduction \[relaxation training, auricular acupuncture\] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

Official Title

Stepped Care for Patients to Optimize Whole Recovery

Quick Facts

Study Start:2023-06-28
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05155163

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. * Seeking treatment at APT Foundation
  2. * Receiving medications for opioid use disorder (MOUD provided by APT)
  3. * Have high impact chronic pain (\>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work)
  4. * Meet DSM-5 criteria for moderate to severe OUD
  5. * In the past 2 months, has an opioid-positive urine test or self-reports opioid use
  6. * Understand English
  7. * Able to provide informed consent
  1. * Have pending surgery or invasive pain management procedure
  2. * Acutely psychotic, suicidal, or homicidal
  3. * Psychiatric instability (e.g., recent suicide attempt)
  4. * Have a contraindication to exercise (e.g. complete heart block)
  5. * Have a pending or planned relocation or pending incarceration

Contacts and Locations

Study Contact

Declan Barry, PhD
CONTACT
203-285-2708
declan.barry@yale.edu
Svetlana Vassilieva
CONTACT
203-435-2497
svetlana.vassilieva@yale.edu

Principal Investigator

Declan Barry
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

APT Foundation
New Haven, Connecticut, 06520
United States
APT Foundation
North Haven, Connecticut, 06473
United States

Collaborators and Investigators

Sponsor: Yale University

  • Declan Barry, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2023-06-28
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-06-28
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Chronic Pain