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Live-Online M-ROCC for Anxiety (Mindful-OBOT Trial)

N/A

Waitlist Available

Led By Zev Schuman-Olivier, MD

Research Sponsored by Cambridge Health Alliance

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 13-24

Awards & highlights

Mindful-OBOT Trial Summary

This trial will compare two groups, one receiving the M-ROCC treatment and one receiving a control treatment, to see which is more effective in helping people abstain from opioids.

Eligible Conditions

Stress Disorder
Anxiety
Depression
Opioid Use Disorder

Mindful-OBOT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 13-24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 13-24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 13-24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of biochemically-confirmed opioid abstinent 2-week time periods

Secondary outcome measures

Number of positive oral-fluid toxicology tests for Benzodiazepines.

Number of positive oral-fluid toxicology tests for Cocaine.

Pain Interference PROMIS (PROMIS-PISF)

+1 more

Other outcome measures

Beck Anxiety Inventory (BAI)

Brief Experiential Avoidance Questionnaire (BEAQ)

Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews

+12 more

Mindful-OBOT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Live-Online Mindful Recovery OUD Care ContinuumExperimental Treatment1 Intervention

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.

Group II: Live-Online ControlActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Live-Online M-ROCC

2021

N/A

~260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cambridge Health AllianceLead Sponsor

57 Previous Clinical Trials

20,292 Total Patients Enrolled

6 Trials studying Anxiety

408 Patients Enrolled for Anxiety

National Center for Complementary and Integrative Health (NCCIH)NIH

831 Previous Clinical Trials

668,673 Total Patients Enrolled

18 Trials studying Anxiety

3,819 Patients Enrolled for Anxiety

Zev Schuman-Olivier, MDPrincipal InvestigatorStudy Principal Investigator

14 Previous Clinical Trials

1,733 Total Patients Enrolled

3 Trials studying Anxiety

159 Patients Enrolled for Anxiety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being granted admittance to this experiment?

"As per the guidelines for inclusion in this trial, participants must fall between 18 years of age and 70."

Answered by AI

How many individuals have chosen to participate in this clinical investigation?

"Indeed, according to clinicaltrials.gov this medical trial is open for enrollment and accepting applications from potential participants. The study was first posted on February 15th 2021 and last updated on August 4th 2021 with a requirement of 236 patients at one site."

Answered by AI

Are there any current openings for participants in this experiment?

"According to the clinicaltrials.gov database, this investigation is still recruiting suitable participants. The study was first posted on February 15th 2021 and then subsequently modified on August 4th 2021."

Answered by AI

To what extent can individuals participate in this research?

"This experimental medication is enrolling 236 adults between 18 and 70 with depression. To be eligible, patients must possess the ability to use a device equipped with video technology as well as have had no more than 90 days of abstinence from illicit substances or alcohol (or suffer from Opioid Use Disorder along with co-morbid anxiety/stress disorder)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278586.