Mindfulness for Mindfulness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh, Pittsburgh, PA
Mindfulness+2 More
Mindfulness - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.

Eligible Conditions

  • Stress (Psychology)
  • Mindfulness
  • Early Life Adversity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 8 Secondary · Reporting Duration: change in mindfulness 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)

assessed across the entire 8-week study period
Feasibility of adherence
Feasibility of retention
Feasibility of safe implementation: Incidence of treatment-emergent increases in mental health symptoms
Week 8
Acceptability: Treatment Expectancies
assessed pre-enrollment
Feasibility of recruitment
change from pre- to post-practice across two-week intervention period
Change in state stress following intervention practice
Week 8
Change in Circulating Inflammatory Biomarkers: CRP
Change in Circulating Inflammatory Biomarkers: IL-10
Change in Circulating Inflammatory Biomarkers: IL-8
Change in Circulating Inflammatory Biomarkers: TNF
Change in Circulating Inflammatory Markers
Change in Global Distress Tolerance
Change in Global Experiential Avoidance
Change in Global Mindfulness
Change in Global Psychosocial Resilience: Life Satisfaction
Change in Global Psychosocial Resilience: Positive Affect
Change in Global Psychosocial Resilience: Self-Efficacy
Change in Global Psychosocial Stress: Anxiety
Change in Global Psychosocial Stress: Depersonalization
Change in Global Psychosocial Stress: Depressive Symptoms
Change in Global Psychosocial Stress: Perceived Stress
Change in Global Psychosocial Stress: Social Isolation
Change in Global Psychosocial Stress: Trauma Symptoms
Change in Global Self-Compassion
Change in Sleep Quality
Week 7
Change in Daily Life Physiological Stress Reactivity
Week 7
Change in Daily Life Negative Affect: Daily
Change in Daily Life Negative Affect: State
Change in Daily Life Positive Affect: Daily
Change in Daily Life Positive Affect: State
Week 7
Change in Daily Life Social Interactions: Daily
Change in Daily Life Social Interactions: Interactions in the past 2.5 hours
Week 7
Change in Daily Life Mindfulness: Acceptance
Change in Daily Life Mindfulness: Awareness
Week 7
Change in Daily Life Subjective Stress: Daily Perceived Stress
Change in Daily Life Subjective Stress: Daily stress events
Change in Daily Life Subjective Stress: State Perceived Stress
Change in Daily Life Subjective Stress: Stress events in the past 2.5 hours
Week 8
Passive sensor stress models
daily stress across two-week intervention period
Daily stress following intervention practice
pre-intervention
Early Life Adversity: Childhood SES indexed by parental education
Early Life Adversity: Childhood SES indexed government assistance
Early Life Adversity: Childhood Trauma
Early Life Adversity: Domestic Violence
Early Life Adversity: Emotional neglect

Trial Safety

Trial Design

2 Treatment Groups

Coping
1 of 2
Mindfulness
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Mindfulness · No Placebo Group · N/A

Mindfulness
Behavioral
Experimental Group · 1 Intervention: Mindfulness · Intervention Types: Behavioral
Coping
Behavioral
ActiveComparator Group · 1 Intervention: Coping · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness
2014
Completed Phase 3
~2750

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in mindfulness 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)
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center  1Photo of University of Pittsburgh Medical Center  2Photo of University of Pittsburgh Medical Center 3
2004First Recorded Clinical Trial
2 TrialsResearching Mindfulness
647 CompletedClinical Trials

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
762 Previous Clinical Trials
640,626 Total Patients Enrolled
4 Trials studying Mindfulness
6,111 Patients Enrolled for Mindfulness
University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,502 Total Patients Enrolled
3 Trials studying Mindfulness
5,388 Patients Enrolled for Mindfulness
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,477 Total Patients Enrolled
1 Trials studying Mindfulness
5,098 Patients Enrolled for Mindfulness
Emily K Lindsay, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of moderate-to-severe physical, emotional, or sexual abuse in childhood.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.