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Digital Mindfulness for Substance Use Disorder Recovery

N/A

Recruiting

Research Sponsored by Yale University

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 baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)

Awards & highlights

Study Summary

This trial tests a digital mindfulness-based treatment for people in early recovery from substance use, to see if it is effective & acceptable. Participants are randomized to usual treatment or usual+digital treatment over 8 weeks.

Who is the study for?

This trial is for adults over 18 who speak English, have finished at least one month of substance use disorder treatment, and used their primary substance within the last six months. They must not be in residential treatment, agree to random assignment, participate fully, provide contact info for follow-up, and own a smartphone with WIFI.Check my eligibility

What is being tested?

The study compares usual recovery treatments with an added digital mindfulness program completed over eight weeks. Participants are randomly placed into either the standard treatment group or the one that includes digital mindfulness exercises.See study design

What are the potential side effects?

Since this trial involves a non-medical intervention (digital mindfulness), typical drug side effects are not expected. However, participants may experience emotional discomfort or distress related to mindfulness practice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adherence to the digital treatment

Completion rates for ecological momentary assessment at baseline

Completion rates for ecological momentary assessment at post-treatment

+3 more

Other outcome measures

Change in frequency of any substance use

Change in frequency of primary substance use

Change in substance-related problems

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAU Plus Digital Mindfulness-Based TreatmentExperimental Treatment2 Interventions

TAU consists of weekly outpatient-based group therapy. The digital mindfulness-based treatment is multimedia app-based program teaching mindfulness skills.

Group II: Treatment-as-Usual (TAU)Active Control1 Intervention

TAU consists of weekly outpatient-based group therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment-as-Usual (TAU)

2010

N/A

~510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,527 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,419 Total Patients Enrolled

Media Library

Digital Mindfulness Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05852015 — N/A

Substance Use Disorder Research Study Groups: Treatment-as-Usual (TAU), TAU Plus Digital Mindfulness-Based Treatment

Substance Use Disorder Clinical Trial 2023: Digital Mindfulness Treatment Highlights & Side Effects. Trial Name: NCT05852015 — N/A

Digital Mindfulness Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852015 — N/A

Frequently Asked Questions

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

Is this experiment currently accessible to individuals seeking treatment?

"Data hosted on clinicaltrials.gov demonstrates that this medical trial is open to recruitment, first posted on May 18th 2023 and updated as recently as the 19th of May."

Answered by AI

How many participants is the trial currently recruiting?

"Affirmative, clinicaltrials.gov reveals that this trial is still in need of applicants. Initially posted on May 18th 2023 and last updated the day after, it requires 34 individuals from one site to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

Corey Roos 2023. "Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852015.