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

Depression Clinical Trial

— Mindful-OBOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278586
• Other study ID #: CHA-IRB-1114/06/19
• Secondary ID: R33AT010125
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: September 19, 2023

Study information

• Verified date: April 2024
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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), level of pain interference measured by the PROMIS Pain Interference Scale (PROMIS-PISF), and the number of positive oral fluid tests for BZD or cocaine during the final 12 weeks of the study. Other exploratory outcomes will be level of anxiety measured by the Beck anxiety inventory (BAI), 24-week intervention 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 a minimum of 12 and a maximum of 25 M-ROCC completers until thematic saturation 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participant lives in Massachusetts, Connecticut, Florida, Maine, New Hampshire, New York, Rhode Island, Texas, or Vermont.

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Opioid-Related Disorders
• Opioid-use Disorder
• Stress Related Disorder

Intervention

Behavioral:
• Live-Online M-ROCC
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. 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. 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.
• 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.

Locations

Country	Name	City	State
United States	Cambridge Health Alliance	Somerville	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge Health Alliance	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fatkin T, Moore SK, Okst K, Creedon TB, Samawi F, Fredericksen AK, Roll D, Oxnard A, Le Cook B, Schuman-Olivier Z. Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. J Subst Abuse Treat. 2021 Nov;130:108415. doi: 10.1016/j.jsat.2021.108415. Epub 2021 Apr 15. Erratum In: J Subst Abuse Treat. 2022 Feb;133:108469. — View Citation

Rosansky JA, Howard L, Goodman H, Okst K, Fatkin T, Fredericksen AK, Sokol R, Gardiner P, Parry G, Cook BL, Weiss RD, Schuman-Olivier ZD. Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT. Contemp Clin Trials. 2024 Feb;137:107417. doi: 10.1016/j.cct.2023.107417. Epub 2023 Dec 20. — View Citation

Schuman-Olivier Z, Fatkin T, Creedon TB, Samawi F, Moore SK, Okst K, Fredericksen AK, Oxnard AS, Roll D, Smith L, Cook BL, Weiss RD. Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Am J Addict. 2023 May;32(3):244-253. doi: 10.1111/ajad.13364. Epub 2022 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Catastrophizing Scale (PCS)	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")	24 Weeks
Other	Substance Craving Scale (SUBCS)	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).	24 Weeks
Other	Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews	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.	24 Weeks
Other	Treatment Retention at 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.	24 Weeks
Other	Difficulties in Emotion Regulation Scale (DERS-16)	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.	24 Weeks
Other	Self-Compassion Scale (SCS)	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.	24 Weeks
Other	Beck Anxiety Inventory (BAI)	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.	24 Weeks
Other	Experiences Questionnaire Decentering Subscale (EQD)	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".	24 Weeks
Other	Self-Critical Rumination Scale (SCRS)	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."	24 Weeks
Other	Brief Experiential Avoidance Questionnaire (BEAQ)	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.	24 Weeks
Other	Perceived Stress Scale (PSS)	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).	24 Weeks
Other	Multidimensional Assessment of Interoceptive Awareness (MAIA-2)	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.	24 Weeks
Other	Interpersonal Mindfulness Scale (IMS)	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).	24 Weeks
Other	Five Facet Mindfulness Questionnaire (FFMQ)	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.	24 Weeks
Other	M-ROCC Qualitative Interviews	We will conduct a minimum of 12 and a maximum of 25 qualitative interviews of M-ROCC completers, defined as having attended at least 3 LDM sessions and 12 MTPC-OUD/MCS sessions of a possible total of 24 sessions. Interviews will last between 30 and 60 minutes. All M-ROCC completers will be invited to interview until thematic saturation is reached. Interviews will be conducted on the HIPAA-compliant videoconferencing technology platform Zoom. Research staff with qualitative interviewing experience will be trained to conduct productive post-study interviews, oversee preparation of transcripts and ensure compatibility for it to be entered into the software program ATLAS.ti version 8.4.4 to enable comparison across qualitative data sources.	24 Weeks
Primary	Number of biochemically-confirmed opioid abstinent 2-week time periods	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.	Weeks 13-24
Secondary	Number of positive oral-fluid toxicology tests for Cocaine.	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.	Weeks 13-24
Secondary	Number of positive oral-fluid toxicology tests for Benzodiazepines.	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.	Weeks 13-24
Secondary	Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)	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).	24 Weeks
Secondary	Pain Interference PROMIS (PROMIS-PISF)	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.	24 Weeks