RECRUITING

Minds and Mentors Program- R33

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 research effort will: The purpose of this study is as follows: 1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120). 2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues. 3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.

Official Title

A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)

Quick Facts

Study Start:2022-01-04
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05363371

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 19 and older
  2. 2. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
  3. 3. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
  4. 4. Are within maintenance phase of MOUD (not actively detoxing)
  5. 5. May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
  6. 6. Capable of reading and understanding English
  7. 7. Able to provide written informed consent (i.e. no surrogate)
  8. 8. Access to a smartphone or a computer with an internet connection
  9. 9. Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)
  1. 1. Significant cognitive impairment
  2. 2. Women who are pregnant (does not impact eligibility post study initiation)
  3. 3. Actively suicidal or homicidal
  4. 4. Active psychosis and/ or
  5. 5. Unstable medical conditions that contraindicate proposed treatment
  6. 1. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
  7. 2. Newly developed active suicidal or homicidal ideation
  8. 3. Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
  9. 4. Inability to return for therapy sessions for four consecutive weeks.

Contacts and Locations

Study Contact

Mercy N Mumba, PhD
CONTACT
682-521-0423
mnmumba@ua.edu

Study Locations (Sites)

Birmingham Veteran Affairs Medical Center
Birmingham, Alabama, 35233
United States
Pathway Healthcare, LLC
Birmingham, Alabama, 35235
United States
Tuscaloosa Veteran Affairs Medical Center
Tuscaloosa, Alabama, 35404
United States
University of Alabama
Tuscaloosa, Alabama, 35487
United States

Collaborators and Investigators

Sponsor: University of Alabama, Tuscaloosa

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 Date2022-01-04
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2022-01-04
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

  • Opioid Use Disorder
  • Mindfulness based therapy
  • Cravings
  • Relapse prevention
  • Treatment retention
  • Depression
  • Stress
  • Anxiety
  • Cortisol
  • Peer Mentors

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Substance Use Disorders
  • Medication Assisted Treatment