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Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase) (Mindful-OBOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278586
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Cambridge Health Alliance

Brief Summary:
This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Stress Related Disorder Anxiety Depression Behavioral: Live-Online M-ROCC Behavioral: Live-Online Control Not Applicable

Detailed Description:

The investigators will conduct a RCT comparing Mindful Recovery Opioid Care Continuum (M-ROCC), a 24-week motivationally-responsive, trauma-sensitive, Group-Based Opioid Treatment (GBOT) program to a live-online control group, on the number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test [negative for opiate, oxycodone, fentanyl, methadone] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).

Clinical secondary outcomes include level of anxiety measured by the Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) among those with at least mild anxiety disorder at baseline (PROMIS-ASF T-score >55), level of pain interference measured by the PROMIS Pain Interference Scale (PROMIS-PISF), and the number of BZD or cocaine positive oral fluid tests (during weeks 13-24 of the study). Other exploratory outcomes will be level of anxiety measured by the Beck Anxiety Inventory (BAI), 24-week treatment retention, as well as mechanisms of self-regulation assessed by self-report and behavioral measures (emotion regulation, decentering/metacognitive monitoring, interoception, experiential avoidance, self-critical rumination, and self-compassion) and their mediating effects on anxiety and opioid abstinence. Qualitative interviews will be conducted with at least 12 M-ROCC completers until thematic saturation is met to examine themes regarding live-online mindfulness delivery and to compare responses with our R21 qualitative outcomes from our in-person M-ROCC group model. Computerized Adaptive Testing for Mental Health (CAT-MH) will also be used to assess changes in psychiatric co-morbidity. Finally, exploratory outcomes of stigma, mindfulness, perceived stress, pain catastrophizing, interpersonal conflict, and shared identity within group will be measured.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms, live-online M-ROCC and live-online control, which are randomly assigned in a 1:1 ratio at the same time and are implemented in parallel.
Masking: Single (Investigator)
Masking Description: The principal investigator will be masked to arm assignment.
Primary Purpose: Treatment
Official Title: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 19, 2021
Estimated Study Completion Date : December 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Live-Online Mindful Recovery OUD Care Continuum
Live-Online Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed for patients with OUD prescribed buprenorphine to be delivered in a live-online environment. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. The live-online M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then a mindfulness maintenance check-in support group.
Behavioral: Live-Online M-ROCC
  1. LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder.
  2. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk.
  3. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk.

After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness.


Active Comparator: Live-Online Control
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.
Behavioral: Live-Online Control
A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.




Primary Outcome Measures :
  1. Number of biochemically-confirmed opioid abstinent 2-week time periods [ Time Frame: Weeks 13-24 ]
    Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.


Secondary Outcome Measures :
  1. Number of positive oral-fluid toxicology tests for Cocaine. [ Time Frame: Weeks 13-24 ]
    Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.

  2. Number of positive oral-fluid toxicology tests for Benzodiazepines. [ Time Frame: Weeks 13-24 ]
    Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.

  3. Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) [ Time Frame: 24 Weeks ]
    The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). This will be assessed among participants with an anxiety disorder (defined as PROMIS >55 at baseline).

  4. Pain Interference PROMIS (PROMIS-PISF) [ Time Frame: 24 Weeks ]
    The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five.


Other Outcome Measures:
  1. Pain Catastrophizing Scale (PCS) [ Time Frame: 24 Weeks ]
    The Pain Catastrophizing Scale (PCS) is a 13-item scale designed to facilitate research on the mechanisms by which catastrophizing impacts pain experience. Participants will be asked to indicate the degree to which they experience certain thoughts and feelings when experiencing pain (e.g. "I feel I can't go on") on a scale from 0 ("Not at all") to 4 ("All the time")

  2. Substance Craving Scale (SUBCS) [ Time Frame: 24 Weeks ]
    The Substance Craving Scale (SUBCS) is a 6-item scale adapted from the Opioid Craving Scale (OCS). The SUBCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and other substance use (including illicit drugs [e.g., cocaine, methamphetamine, etc.], using unprescribed pills [e.g., Adderall, etc.], using prescribed medication in ways or at doses for which they were not prescribed [e.g., Klonopin, etc.], or drinking alcohol).

  3. Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews [ Time Frame: 24 Weeks ]
    Computer Adaptive Testing for Mental Health (CAT-MH) interviews are diagnostic interviews designed to be completed online using a computer, tablet or phone. Items from each of the modules for depression (CAT-DI), anxiety (ANX-CAT), mania and hypomania (M/HM-CAT), PTSD (PTSD-CAT), psychosis (PSY-S-CAT), suicidality (SS-CAT), and substance abuse (SUD-CAT) are chosen from large item banks based on multidimensional item response theory, adapting each item presented to the individual's severity so that different individuals are tested with different items depending on their severity level.

  4. Treatment Retention at 24 Weeks [ Time Frame: 24 Weeks ]
    Treatment retention at 24 weeks, defined as any active BUP prescription within the last 28 days (i.e., between Weeks 20-24 of participant enrollment). This will be determined from the weekly survey, which will track BUP prescription over time. Time to treatment discontinuation will also be assessed.

  5. Difficulties in Emotion Regulation Scale (DERS-16) [ Time Frame: 24 Weeks ]
    The DERS-16 is a 16-item self-report scale designed to assess emotional dysregulation. The scale is a shortened version of the original 36-item scale. The scale assesses 5 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, limited access to emotion regulation strategies, and lack of emotional clarity.

  6. Self-Compassion Scale (SCS) [ Time Frame: 24 Weeks ]
    The Self-Compassion Scale (SCS)265 is a 26-item Self-Compassion Scale. This scale evaluates six different aspects of self-compassion: Self-Kindness (e.g., ''I try to be understanding and patient toward those aspects of my personality I don't like''), Self-Judgment (e.g., ''I'm disapproving and judgmental about my own flaws and inadequacies''), Common Humanity (e.g., ''I try to see my failings as part of the human condition''), Isolation (e.g., ''When I feel inadequate in some way, I try to remind myself that feelings of inadequacy are shared by most people"), Mindfulness (e.g., ''When something painful happens I try to take a balanced view of the situation''), and Over-Identification (e.g., ''When I'm feeling down I tend to obsess and fixate on everything that's wrong.''). The scale is scored on a 5-point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored. Duration: 5 min.

  7. Beck Anxiety Inventory (BAI) [ Time Frame: 24 Weeks ]
    The Beck Anxiety Inventory (BAI) consists of 21 items with a Likert scale ranging from 0 to 3 and raw scores ranging from 0 to 63.

  8. Experiences Questionnaire Decentering Subscale (EQD) [ Time Frame: 24 Weeks ]
    The EQD is a subset of the 20-item self-report measure of experiences, consisting of 10 questions measuring decentering. The EQD uses a 5-point Likert scale with responses from "never" to "all the time".

  9. Self-Critical Rumination Scale (SCRS) [ Time Frame: 24 Weeks ]
    The SCRS is a 10-item scale measuring the degree to which the person repeatedly evaluates themselves negatively. Specifically, the scale measures constructs such as shame and self-criticism. Participants respond on a 7-point Likert scale from "not at all" to "very well."

  10. Brief Experiential Avoidance Questionnaire (BEAQ) [ Time Frame: 24 Weeks ]
    The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item scale developed to assess a broad range of experiential avoidance (EA) content. Answers are based on a 6-point Likert scale.

  11. Perceived Stress Scale (PSS) [ Time Frame: 24 Weeks ]
    The PSS Scale uses 14 items to measure the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).

  12. Multidimensional Assessment of Interoceptive Awareness (MAIA-2) [ Time Frame: 24 Weeks ]
    The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The 6 point Likert scale (ranging from 0-5) assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. We will not be collecting the not-distracting and not-worrying subscales for this study.

  13. Interpersonal Mindfulness Scale (IMS) [ Time Frame: 24 Weeks ]
    Interpersonal Mindfulness Scale (IMS) is a 27-item scale that assesses trait mindfulness in the context of interpersonal interactions and relationships. Factors include Presence, Awareness of Self and Others, Nonjudgmental Acceptance, and Nonreactivity. Participants are asked to rate their response from 1 (almost never) to 5 (almost always).

  14. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 24 Weeks ]
    The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five facets that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." Subjects rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient receives a current buprenorphine prescription from a prescriber in Massachusetts
  • Diagnosis of opioid use disorder prescribed a stable dose of buprenorphine (at least 4 weeks)
  • Less than 90 days of abstinence (from non-prescribed opioids or benzodiazepines, cocaine, or alcohol) OR OUD with a co-morbid anxiety or stress disorder (as evaluated by Computerized Adaptive Testing for Mental Health [CAT-MH] or PROMIS-ASF > 55).
  • Able to use an electronic device with a videocamera to attend study groups and complete questionnaires.
  • Sufficient English fluency to understand procedures and questionnaires
  • Ability to provide informed consent.

Exclusion Criteria:

  • Active psychosis
  • Bipolar I disorder history or severe level of mania on CAT-MH (>71)
  • Acute suicidality or self-injurious behavior or severe level of suicidality on CAT-SS (>71)
  • Cognitive inability as demonstrated by both the inability to complete an informed consent assessment AND complete the Montreal Cognitive Assessment Blind (MOCA BLIND) <24 on two different days
  • Current participation in another experimental research study
  • Previous participation in an 8-week intensive Mindfulness-Based Intervention in past 3 years or participation in the MINDFUL-OBOT pilot study
  • Expected medical hospitalization in next 6 months
  • Expected incarceration in next 6 months
  • Substance use severity requiring likely inpatient treatment in opinion of principal investigator (e.g., severe alcohol withdrawal symptoms, severe benzodiazepine withdrawal symptoms, etc.).
  • Inability to participate in group intervention without disrupting group in opinion of principal investigator or site PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278586


Contacts
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Contact: Thomas P Fatkin, BA 617-851-8625 tfatkin@challiance.org
Contact: Kayley Okst, BA 857-270-0372 kokst@challiance.org

Locations
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United States, Massachusetts
Cambridge Health Alliance Recruiting
Somerville, Massachusetts, United States, 02143
Contact: Thomas P Fatkin, BA    617-806-8567    tfatkin@challiance.org   
Contact: Kayley Okst, BA    857-270-0372    kokst@challiance.org   
Principal Investigator: Zev D Schuman-Olivier, MD         
Sponsors and Collaborators
Cambridge Health Alliance
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Zev Schuman-Olivier, MD Study Principal Investigator
  Study Documents (Full-Text)

Documents provided by Cambridge Health Alliance:
Informed Consent Form  [PDF] May 18, 2021

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Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT04278586    
Other Study ID Numbers: CHA-IRB-1114/06/19
R33AT010125 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Anxiety Disorders
Pathologic Processes
Mental Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders