<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977988</url>
  </required_header>
  <id_info>
    <org_study_id>UP-14-00391-AM001</org_study_id>
    <secondary_id>5R01DA038648-04</secondary_id>
    <nct_id>NCT02977988</nct_id>
  </id_info>
  <brief_title>Women's Treatment and Early Recovery</brief_title>
  <acronym>MBRP-W</acronym>
  <official_title>Neural Mechanisms in Women's Treatment and Early Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of&#xD;
      alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related&#xD;
      to crime, lost work productivity and health care. While effective treatments exist, over half&#xD;
      of those who enter treatment for substance use disorders drop out early in treatment and&#xD;
      return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis&#xD;
      of substance use disorder (SUD) and relapse risk. Low-income women report high levels of&#xD;
      stress in SUD residential treatment stemming from significant economic and family stressors&#xD;
      in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,&#xD;
      especially in early stages of residential treatment, is a major concern because it can&#xD;
      increase dropout. Dropout from residential treatment places women at risk of substance use&#xD;
      relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions&#xD;
      with racially/ethnically diverse low-income women with SUDs, especially regarding the&#xD;
      efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout&#xD;
      and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,&#xD;
      Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women&#xD;
      (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates&#xD;
      relapse prevention, addresses literacy level, and is relevant to issues surrounding&#xD;
      treatment- and relapse-related stressors of disadvantaged women. The current project has&#xD;
      three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention&#xD;
      and substance use relapse in racially/ethnically diverse low-income women; (2) to determine&#xD;
      the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes&#xD;
      associated with program effects. A rationale for MBRP-W is the need for self-initiated stress&#xD;
      management skills in women with SUDs during the early stressful periods of residential&#xD;
      treatment that increase risk of dropout and relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  This randomized clinical trial will deliver two interventions as add-ons to residential&#xD;
           substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery:&#xD;
           Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery&#xD;
           (B&amp;R) which serves as an active psychoeducational attention control group.&#xD;
&#xD;
        -  Participants (N=165) who meet study eligibility criteria based on intake assessment will&#xD;
           be recruited and complete baseline assessments during weeks 3-6 after entry into a&#xD;
           residential treatment program. Participants will be randomly assigned to interventions&#xD;
           using Urn randomization. All participants (MBRP-W and B&amp;R) will receive SUD treatment as&#xD;
           normally provided by the treatment program. Fifteen participants from each intervention&#xD;
           group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.&#xD;
&#xD;
        -  Participants will be adult females who have been admitted to a residential treatment&#xD;
           center in an urban area of California and who are diagnosed with a SUD based on clinical&#xD;
           intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)&#xD;
           diagnostic assessment.&#xD;
&#xD;
        -  MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical&#xD;
           populations. Facilitators will have previous experience in MBSR facilitation and will be&#xD;
           trained in MBRP-W. Each session has a central theme and is divided into five segments&#xD;
           consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of&#xD;
           session objectives, (c) a brief didactic psycho-educational presentation and discussion&#xD;
           based on the session's theme, (d) experiential and formal meditation or other practices,&#xD;
           and (e) readings and practice assignments for the next class.&#xD;
&#xD;
        -  B&amp;R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations.&#xD;
           Facilitators will be trained in B&amp;R. The B&amp;R group will receive didactic education on&#xD;
           the neurobiology of addiction. B&amp;R contains no information on behavior change, relapse&#xD;
           prevention, stress reduction, or mindfulness-based or relapse-related content. The&#xD;
           intervention was developed over three years with a population similar to that of the&#xD;
           current study (i.e., racially/ethnically diverse and low-income women in SUD treatment)&#xD;
           with input and review from focus group participants, care providers in SUD treatment,&#xD;
           and three experts on the neurobiology of addiction. Topics include: (1) brain structure&#xD;
           and function related to addiction, (2) effects of various types of substance use on the&#xD;
           brain, and (3) rewarding effects of substance use and how these rewarding effects can&#xD;
           lead to addiction.&#xD;
&#xD;
        -  There are three data collection points, 1) baseline, 2) immediate post-intervention, and&#xD;
           3) 8-months post-intervention completion. Data will be collected in-person by research&#xD;
           interviewers via computer-assisted interviews, which includes administration of an&#xD;
           alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to&#xD;
           assess drug use. Interviews will be conducted at the treatment program (for those who&#xD;
           remain in residential treatment) or at convenient locations for participants no longer&#xD;
           in treatment. Baseline interview will occur prior to randomization, post-intervention&#xD;
           interview will occur within 1-2 weeks of the last group session, and the follow-up&#xD;
           interview will occur at an 8-months post-intervention completion window. Brain imaging&#xD;
           for a subsample of participants will be completed at baseline and immediate&#xD;
           post-intervention.&#xD;
&#xD;
        -  Number of intervention program class sessions attended will be collected for all&#xD;
           enrolled participants.&#xD;
&#xD;
        -  Participant Satisfaction Surveys measuring acceptability, credibility, and perceived&#xD;
           utility of the study arms will be administered to both groups at two class sessions.&#xD;
&#xD;
        -  Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of&#xD;
           mindfulness skills to address life challenges, will be administered to the MBRP-W&#xD;
           participants at four class sessions as well as at follow-up. Mindfulness practice effort&#xD;
           will also be assessed at these same four class sessions.&#xD;
&#xD;
        -  An in-treatment clinical record review of services will be collected weekly for the&#xD;
           duration of residential treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2015</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days in residential treatment</measure>
    <time_frame>11 month interval</time_frame>
    <description>Days in residential treatment confirmed by residential clinic archival records</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of and relapse to alcohol and illicit drugs</measure>
    <time_frame>11 month interval</time_frame>
    <description>Use of and relapse to alcohol and illicit drug obtained from the interviewer-assisted timeline followback calendar and confirmed by urine drug screen and alcohol breathalyzer test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neural correlates</measure>
    <time_frame>10 week interval</time_frame>
    <description>Brain tissue morphology and neural network correlates of mindfulness training obtained from magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) in subsample of n=15 in each treatment group at pre- and immediate post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological mechanisms of action underlying intervention</measure>
    <time_frame>11 month interval</time_frame>
    <description>Self-report of mindfulness qualities, perceived stress, psychological distress, distress tolerance, self-regulation, craving, and negative affect</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Substance-related Disorders</condition>
  <arm_group>
    <arm_group_label>Mindfulness Meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness-Based Relapse Prevention-Women (MBRP-W)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brain and Recovery (B&amp;R)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Meditation</intervention_name>
    <description>MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.</description>
    <arm_group_label>Mindfulness Meditation</arm_group_label>
    <other_name>Mindfulness-Based Relapse Prevention-Women (MBRP-W)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain and Recovery (B&amp;R)</intervention_name>
    <description>B&amp;R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B&amp;R group will receive didactic education on the neurobiology of addiction. B&amp;R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.</description>
    <arm_group_label>Active Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for parent study:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Adult in California (18 years or older)&#xD;
&#xD;
          -  Diagnosed with a substance use disorder (SUD)&#xD;
&#xD;
          -  Speaks fluent English&#xD;
&#xD;
          -  Client at study site, substance use disorder residential facility at time of&#xD;
             recruitment&#xD;
&#xD;
        Exclusion criteria for parent study:&#xD;
&#xD;
          -  Inability to comprehend informed consent&#xD;
&#xD;
          -  Unwilling to sign informed consent&#xD;
&#xD;
          -  Cognitive impairment, psychotic disorder or severe chronic mental health condition&#xD;
             based on clinical intake DSM-V assessment&#xD;
&#xD;
          -  Older than 65 years of age&#xD;
&#xD;
          -  Reported suicidality in last 30 days&#xD;
&#xD;
          -  Current prisoner&#xD;
&#xD;
          -  Pregnant in the 3rd trimester&#xD;
&#xD;
          -  Pregnant (MRI subsample only)&#xD;
&#xD;
          -  Not willing to be audio recorded&#xD;
&#xD;
          -  Not willing to have data stored for research purposes&#xD;
&#xD;
        Additional exclusion criteria for brain imaging sub-study:&#xD;
&#xD;
          -  Older than 50 years of age&#xD;
&#xD;
          -  Not in good general health&#xD;
&#xD;
          -  Left handed (with a mean item score &gt;1 on the handedness scale)&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Current medical devices (cardiac pacemaker, implanted cardiac defibrillator, carotid&#xD;
             artery vascular clamp, neurostimulator, cochlear implant, metal fragments (including&#xD;
             shrapnel) in the head, eyes, or skin, vascular stent, ocular implant, penile implant,&#xD;
             vascular filter for clots (including Greenfield, Umbrella, or Birds Nest filters)&#xD;
&#xD;
          -  Other non-removable devices (IUD, dental braces or retainer, piercings that cannot be&#xD;
             removed prior to resting, permanent eye-liner)&#xD;
&#xD;
          -  Body Mass Index (BMI) greater than 36&#xD;
&#xD;
          -  History of head trauma resulting in loss of consciousness for more than 5 minutes&#xD;
&#xD;
          -  Documented or subjectively reported claustrophobia&#xD;
&#xD;
          -  Having hair extensions or a wig connected by wire&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David S Black, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prototypes' Pomona Women's Center</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://goamra.org</url>
    <description>American Mindfulness Research Association</description>
  </link>
  <reference>
    <citation>Amaro H, Spear S, Vallejo Z, Conron K, Black DS. Feasibility, acceptability, and preliminary outcomes of a mindfulness-based relapse prevention intervention for culturally-diverse, low-income women in substance use disorder treatment. Subst Use Misuse. 2014 Apr;49(5):547-59. doi: 10.3109/10826084.2013.852587.</citation>
    <PMID>24611850</PMID>
  </reference>
  <reference>
    <citation>Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial. Contemp Clin Trials. 2014 Sep;39(1):22-7. doi: 10.1016/j.cct.2014.06.013. Epub 2014 Jul 1.</citation>
    <PMID>24993561</PMID>
  </reference>
  <reference>
    <citation>Hanley A, Garland EL, Black DS. Use of mindful reappraisal coping among meditation practitioners. J Clin Psychol. 2014 Mar;70(3):294-301. doi: 10.1002/jclp.22023. Epub 2013 Jul 1.</citation>
    <PMID>23818289</PMID>
  </reference>
  <reference>
    <citation>Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.</citation>
    <PMID>26858469</PMID>
  </reference>
  <reference>
    <citation>Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.</citation>
    <PMID>26799456</PMID>
  </reference>
  <reference>
    <citation>Galla BM, O'Reilly GA, Kitil MJ, Smalley SL, Black DS. Community-Based Mindfulness Program for Disease Prevention and Health Promotion: Targeting Stress Reduction. Am J Health Promot. 2015 Sep-Oct;30(1):36-41. doi: 10.4278/ajhp.131107-QUAN-567. Epub 2014 Aug 27.</citation>
    <PMID>25162319</PMID>
  </reference>
  <reference>
    <citation>Garland EL, Black DS. Mindfulness for chronic pain and prescription opioid misuse: novel mechanisms and unresolved issues. Subst Use Misuse. 2014 Apr;49(5):608-11. doi: 10.3109/10826084.2014.852801. No abstract available.</citation>
    <PMID>24611857</PMID>
  </reference>
  <reference>
    <citation>Peltz L, Black DS. The thinking mind as addiction: mindfulness as antidote. Subst Use Misuse. 2014 Apr;49(5):605-7. doi: 10.3109/10826084.2014.852803. No abstract available.</citation>
    <PMID>24611856</PMID>
  </reference>
  <reference>
    <citation>Witkiewitz K, Black DS. Unresolved issues in the application of mindfulness-based interventions for substance use disorders. Subst Use Misuse. 2014 Apr;49(5):601-4. doi: 10.3109/10826084.2014.852797. No abstract available.</citation>
    <PMID>24611855</PMID>
  </reference>
  <reference>
    <citation>Black DS. Mindfulness-based interventions: an antidote to suffering in the context of substance use, misuse, and addiction. Subst Use Misuse. 2014 Apr;49(5):487-91. doi: 10.3109/10826084.2014.860749.</citation>
    <PMID>24611846</PMID>
  </reference>
  <reference>
    <citation>Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. No abstract available.</citation>
    <PMID>22217122</PMID>
  </reference>
  <results_reference>
    <citation>Amaro H, Black DS. Moment-by-Moment in Women's Recovery: Randomized controlled trial protocol to test the efficacy of a mindfulness-based intervention on treatment retention and relapse prevention among women in residential treatment for substance use disorder. Contemp Clin Trials. 2017 Nov;62:146-152. doi: 10.1016/j.cct.2017.09.004. Epub 2017 Sep 14.</citation>
    <PMID>28918120</PMID>
  </results_reference>
  <results_reference>
    <citation>Black DS, Amaro H. Moment-by-Moment in Women's Recovery (MMWR): Mindfulness-based intervention effects on residential substance use disorder treatment retention in a randomized controlled trial. Behav Res Ther. 2019 Sep;120:103437. doi: 10.1016/j.brat.2019.103437. Epub 2019 Jul 7.</citation>
    <PMID>31419610</PMID>
  </results_reference>
  <results_reference>
    <citation>Kechter A, Amaro H, Black DS. Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. Mindfulness (N Y). 2019 Feb;10(2):215-233. doi: 10.1007/s12671-018-0974-4. Epub 2018 Jun 22.</citation>
    <PMID>30854147</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>David Black</investigator_full_name>
    <investigator_title>Assistant Professor of Preventive Medicine and Social Work</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Women</keyword>
  <keyword>Relapse prevention</keyword>
  <keyword>Clinical trial</keyword>
  <keyword>Substance use disorder</keyword>
  <keyword>Ethnically diverse</keyword>
  <keyword>Underserved</keyword>
  <keyword>Health disparities</keyword>
  <keyword>Stress</keyword>
  <keyword>Addiction</keyword>
  <keyword>Latina/Hispanic</keyword>
  <keyword>African American</keyword>
  <keyword>Treatment retention</keyword>
  <keyword>Residential treatment</keyword>
  <keyword>Brain Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not until 12 months after final outcomes manuscript is submitted for publication.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>June 2, 2021</submitted>
    <returned>June 24, 2021</returned>
    <submitted>October 28, 2022</submitted>
    <returned>November 21, 2022</returned>
    <submitted>February 15, 2023</submitted>
    <returned>March 10, 2023</returned>
    <submitted>May 19, 2023</submitted>
    <returned>June 15, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977988
org study id: UP-14-00391-AM001
secondary id: 5R01DA038648-04
nct id: NCT02977988
lead sponsor: 
collaborator: 
has dmc: No
Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of
      alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related
      to crime, lost work productivity and health care. While effective treatments exist, over half
      of those who enter treatment for substance use disorders drop out early in treatment and
      return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis
      of substance use disorder (SUD) and relapse risk. Low-income women report high levels of
      stress in SUD residential treatment stemming from significant economic and family stressors
      in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,
      especially in early stages of residential treatment, is a major concern because it can
      increase dropout. Dropout from residential treatment places women at risk of substance use
      relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions
      with racially/ethnically diverse low-income women with SUDs, especially regarding the
      efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout
      and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,
      Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women
      (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates
      relapse prevention, addresses literacy level, and is relevant to issues surrounding
      treatment- and relapse-related stressors of disadvantaged women. The current project has
      three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention
      and substance use relapse in racially/ethnically diverse low-income women; (2) to determine
      the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes
      associated with program effects. A rationale for MBRP-W is the need for self-initiated stress
      management skills in women with SUDs during the early stressful periods of residential
      treatment that increase risk of dropout and relapse.
-  This randomized clinical trial will deliver two interventions as add-ons to residential
           substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery:
           Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery
           (B&R) which serves as an active psychoeducational attention control group.

        -  Participants (N=165) who meet study eligibility criteria based on intake assessment will
           be recruited and complete baseline assessments during weeks 3-6 after entry into a
           residential treatment program. Participants will be randomly assigned to interventions
           using Urn randomization. All participants (MBRP-W and B&R) will receive SUD treatment as
           normally provided by the treatment program. Fifteen participants from each intervention
           group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.

        -  Participants will be adult females who have been admitted to a residential treatment
           center in an urban area of California and who are diagnosed with a SUD based on clinical
           intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
           diagnostic assessment.

        -  MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical
           populations. Facilitators will have previous experience in MBSR facilitation and will be
           trained in MBRP-W. Each session has a central theme and is divided into five segments
           consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of
           session objectives, (c) a brief didactic psycho-educational presentation and discussion
           based on the session's theme, (d) experiential and formal meditation or other practices,
           and (e) readings and practice assignments for the next class.

        -  B&R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations.
           Facilitators will be trained in B&R. The B&R group will receive didactic education on
           the neurobiology of addiction. B&R contains no information on behavior change, relapse
           prevention, stress reduction, or mindfulness-based or relapse-related content. The
           intervention was developed over three years with a population similar to that of the
           current study (i.e., racially/ethnically diverse and low-income women in SUD treatment)
           with input and review from focus group participants, care providers in SUD treatment,
           and three experts on the neurobiology of addiction. Topics include: (1) brain structure
           and function related to addiction, (2) effects of various types of substance use on the
           brain, and (3) rewarding effects of substance use and how these rewarding effects can
           lead to addiction.

        -  There are three data collection points, 1) baseline, 2) immediate post-intervention, and
           3) 8-months post-intervention completion. Data will be collected in-person by research
           interviewers via computer-assisted interviews, which includes administration of an
           alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to
           assess drug use. Interviews will be conducted at the treatment program (for those who
           remain in residential treatment) or at convenient locations for participants no longer
           in treatment. Baseline interview will occur prior to randomization, post-intervention
           interview will occur within 1-2 weeks of the last group session, and the follow-up
           interview will occur at an 8-months post-intervention completion window. Brain imaging
           for a subsample of participants will be completed at baseline and immediate
           post-intervention.

        -  Number of intervention program class sessions attended will be collected for all
           enrolled participants.

        -  Participant Satisfaction Surveys measuring acceptability, credibility, and perceived
           utility of the study arms will be administered to both groups at two class sessions.

        -  Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of
           mindfulness skills to address life challenges, will be administered to the MBRP-W
           participants at four class sessions as well as at follow-up. Mindfulness practice effort
           will also be assessed at these same four class sessions.

        -  An in-treatment clinical record review of services will be collected weekly for the
           duration of residential treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Days in residential treatment
time frame: 11 month interval
description: Days in residential treatment confirmed by residential clinic archival records
measure: Use of and relapse to alcohol and illicit drugs
time frame: 11 month interval
description: Use of and relapse to alcohol and illicit drug obtained from the interviewer-assisted timeline followback calendar and confirmed by urine drug screen and alcohol breathalyzer test
measure: Neural correlates
time frame: 10 week interval
description: Brain tissue morphology and neural network correlates of mindfulness training obtained from magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) in subsample of n=15 in each treatment group at pre- and immediate post-intervention.
measure: Psychological mechanisms of action underlying intervention
time frame: 11 month interval
description: Self-report of mindfulness qualities, perceived stress, psychological distress, distress tolerance, self-regulation, craving, and negative affect
arm group label: Mindfulness Meditation
arm group type: Experimental
description: Mindfulness-Based Relapse Prevention-Women (MBRP-W)
arm group label: Active Comparator
arm group type: Active Comparator
description: Brain and Recovery (B&R)
intervention type: Behavioral
intervention name: Mindfulness Meditation
description: MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.
arm group label: Mindfulness Meditation
other name: Mindfulness-Based Relapse Prevention-Women (MBRP-W)
intervention type: Behavioral
intervention name: Brain and Recovery (B&R)
description: B&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B&R group will receive didactic education on the neurobiology of addiction. B&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.
arm group label: Active Comparator
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David S Black, PhD, MPH
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
url: https://goamra.org
description: American Mindfulness Research Association
citation: Amaro H, Spear S, Vallejo Z, Conron K, Black DS. Feasibility, acceptability, and preliminary outcomes of a mindfulness-based relapse prevention intervention for culturally-diverse, low-income women in substance use disorder treatment. Subst Use Misuse. 2014 Apr;49(5):547-59. doi: 10.3109/10826084.2013.852587.
PMID: 24611850
citation: Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial. Contemp Clin Trials. 2014 Sep;39(1):22-7. doi: 10.1016/j.cct.2014.06.013. Epub 2014 Jul 1.
PMID: 24993561
citation: Hanley A, Garland EL, Black DS. Use of mindful reappraisal coping among meditation practitioners. J Clin Psychol. 2014 Mar;70(3):294-301. doi: 10.1002/jclp.22023. Epub 2013 Jul 1.
PMID: 23818289
citation: Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.
PMID: 26858469
citation: Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
PMID: 26799456
citation: Galla BM, O'Reilly GA, Kitil MJ, Smalley SL, Black DS. Community-Based Mindfulness Program for Disease Prevention and Health Promotion: Targeting Stress Reduction. Am J Health Promot. 2015 Sep-Oct;30(1):36-41. doi: 10.4278/ajhp.131107-QUAN-567. Epub 2014 Aug 27.
PMID: 25162319
citation: Garland EL, Black DS. Mindfulness for chronic pain and prescription opioid misuse: novel mechanisms and unresolved issues. Subst Use Misuse. 2014 Apr;49(5):608-11. doi: 10.3109/10826084.2014.852801. No abstract available.
PMID: 24611857
citation: Peltz L, Black DS. The thinking mind as addiction: mindfulness as antidote. Subst Use Misuse. 2014 Apr;49(5):605-7. doi: 10.3109/10826084.2014.852803. No abstract available.
PMID: 24611856
citation: Witkiewitz K, Black DS. Unresolved issues in the application of mindfulness-based interventions for substance use disorders. Subst Use Misuse. 2014 Apr;49(5):601-4. doi: 10.3109/10826084.2014.852797. No abstract available.
PMID: 24611855
citation: Black DS. Mindfulness-based interventions: an antidote to suffering in the context of substance use, misuse, and addiction. Subst Use Misuse. 2014 Apr;49(5):487-91. doi: 10.3109/10826084.2014.860749.
PMID: 24611846
citation: Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. No abstract available.
PMID: 22217122
citation: Amaro H, Black DS. Moment-by-Moment in Women's Recovery: Randomized controlled trial protocol to test the efficacy of a mindfulness-based intervention on treatment retention and relapse prevention among women in residential treatment for substance use disorder. Contemp Clin Trials. 2017 Nov;62:146-152. doi: 10.1016/j.cct.2017.09.004. Epub 2017 Sep 14.
PMID: 28918120
citation: Black DS, Amaro H. Moment-by-Moment in Women's Recovery (MMWR): Mindfulness-based intervention effects on residential substance use disorder treatment retention in a randomized controlled trial. Behav Res Ther. 2019 Sep;120:103437. doi: 10.1016/j.brat.2019.103437. Epub 2019 Jul 7.
PMID: 31419610
citation: Kechter A, Amaro H, Black DS. Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. Mindfulness (N Y). 2019 Feb;10(2):215-233. doi: 10.1007/s12671-018-0974-4. Epub 2018 Jun 22.
PMID: 30854147
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: David Black
investigator title: Assistant Professor of Preventive Medicine and Social Work
mesh term: Substance-Related Disorders
sharing ipd: No
ipd description: Not until 12 months after final outcomes manuscript is submitted for publication.
submitted: June 2, 2021
returned: June 24, 2021
submitted: October 28, 2022
returned: November 21, 2022
submitted: February 15, 2023
returned: March 10, 2023
submitted: May 19, 2023
returned: June 15, 2023