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Remote Mindfulness Training for Stress (ReMind Trial)
Phase 1
Recruiting
Led By Emily K Lindsay, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
Awards & highlights
ReMind Trial Summary
This trial will test whether mindfulness and coping interventions delivered via smartphone can help reduce stress and inflammation in young adults with a history of early life adversity.
Who is the study for?
This trial is for English-speaking young adults aged 18-29 who have experienced moderate-to-severe abuse in childhood. Participants must own a smartphone and be able to follow the study's procedures. It excludes shift workers, those with chronic physical or mental diseases, substance use disorders, pregnancy, regular mind-body practitioners, and certain medication users.Check my eligibility
What is being tested?
The study tests a two-week mindfulness training via smartphone app against a coping control intervention in individuals with early life adversity. Both groups receive audio lessons and practice prompts three times daily. The effects on stress and inflammation will be measured through questionnaires, blood samples, and sensor data from smartphones/wearables.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like mindfulness training delivered through an app, side effects are minimal but may include discomfort or emotional distress related to engaging with one's thoughts during the practice.
ReMind Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in hr reactivity assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in hr reactivity assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability: Treatment Expectancies
Change in Circulating Inflammatory Markers
Change in Daily Life Physiological Stress Reactivity
+8 moreSecondary outcome measures
Change in Daily Life Mindfulness: Acceptance
Change in Daily Life Mindfulness: Awareness
Change in Daily Life Negative Affect: Daily
+5 moreOther outcome measures
Change in Circulating Inflammatory Biomarkers: CRP
Change in Circulating Inflammatory Biomarkers: IL-10
Change in Circulating Inflammatory Biomarkers: IL-8
+23 moreReMind Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MindfulnessExperimental Treatment1 Intervention
Mindfulness intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train meditation techniques for 3 mindfulness skills: concentration, sensory clarity, and equanimity. Practice prompts delivered 3x daily build on the skills trained in each lesson.
Group II: CopingActive Control1 Intervention
Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness
2014
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,714 Previous Clinical Trials
7,511,253 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,655 Total Patients Enrolled
University of PittsburghLead Sponsor
1,729 Previous Clinical Trials
16,307,410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic mental health condition or have had suicidal thoughts.I have a long-term illness like cancer, HIV, heart disease, diabetes, or a bleeding disorder.I am currently taking antibiotics, antivirals, or antimicrobials.I am between 18 and 29 years old.I am not on medications that affect stress hormones, blood pressure, inflammation, or clotting.You have experienced significant physical, emotional, or sexual abuse during your childhood.
Research Study Groups:
This trial has the following groups:- Group 1: Coping
- Group 2: Mindfulness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Stress Patient Testimony for trial: Trial Name: NCT05516108 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who would be suitable candidates for this research trial?
"Individuals who meet the criteria of being between 18 and 29 years old, in addition to exhibiting mindful behaviours, are eligible for recruitment into this trial. A total of 80 participants must be enrolled before its completion."
Answered by AI
What is the intake capacity of this clinical trial?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this clinical trial is currently soliciting participants, with the original posting occurring on September 1st 2022 and the latest update taking place on September 2nd 2022. To complete their study, 80 individuals need to be recruited from one medical centre."
Answered by AI
Is the age criterion for this clinical trial inclusive of those aged eighty and above?
"This trial is designed for people aged 18 to 29, with an additional 30 studies available specifically for minors and 120 separate clinical trials catering to patients 65 years or older."
Answered by AI
What beneficial results are expected from this clinical research?
"This clinical trial's primary outcome is the feasibility of patient retention, while secondary objectives include ascertaining changes in daily negative and positive affect as well as alterations to social interactions. The progress will be measured over a period pre-enrollment."
Answered by AI
Is the recruitment process for this experiment still accepting participants?
"As noted on clinicaltrials.gov, the medical trial is engaging in active recruitment of participants; it was first posted to the website on September 1st 2022 and recently updated on September 2nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Will I have to consume anything?
PatientReceived no prior treatments
Why did patients apply to this trial?
I am interested in research and want to be a part of it.
PatientReceived no prior treatments
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