NCT02433431

Brief Summary

The purpose of this study is to test the active components of mindfulness meditation for reducing psychological stress and improving biomarkers of health. This study compares the effects of three brief trainings: (1) training in both present-moment attention and mindful acceptance, (2) training in present-focused attention, and (3) an active psychological training with no mindfulness content.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

April 23, 2015

Last Update Submit

May 13, 2016

Conditions

Psychological StressMindfulness

Keywords

mindfulnesspsychological stressimmune markerwellness programsmobile applicationscortisol

Outcome Measures

Primary Outcomes (2)

  • Daily life stress assessed via Ecological Momentary Assessment

    change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  • Inflammatory Biomarkers assessed via Dried Blood Spot

    Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).

    change from baseline to post-intervention, which is an average of 3.5 weeks

Secondary Outcomes (6)

  • Daily life state attention and acceptance assessed via Ecological Momentary Assessment

    change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  • Subjective stress in response to social evaluative threat (TSST)

    assessed at post-intervention, which is an average of 3.5 weeks

  • Salivary Cortisol AUC in response to social evaluative threat (TSST)

    assessed at post-intervention, which is an average of 3.5 weeks, at time 0, and 25, 35, and 60 minutes post-TSST

  • Blood Pressure reactivity to social evaluative threat (TSST)

    assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session

  • Evening salivary cortisol

    change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  • +1 more secondary outcomes

Other Outcomes (17)

  • Daily life affect assessed via Ecological Momentary Assessment

    change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  • Daily life social interactions assessed via Ecological Momentary Assessment

    change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks

  • Perceived stress measured by the PSS

    change from baseline to post-intervention, which is an average of 3.5 weeks

  • +14 more other outcomes

Study Arms (3)

Mindfulness Training

ACTIVE COMPARATOR

14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance

Behavioral: Mindfulness Training

Mindful Attention Only Training

ACTIVE COMPARATOR

14-lesson audio-guided mindfulness training program instructing present-moment attention only

Behavioral: Mindful Attention Only Training

Analytic Thinking Training

ACTIVE COMPARATOR

14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness

Behavioral: Analytic Thinking Training

Interventions

Mindfulness TrainingBEHAVIORAL

Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

Mindfulness Training
Mindful Attention Only TrainingBEHAVIORAL

Mindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

Mindful Attention Only Training
Analytic Thinking TrainingBEHAVIORAL

Comparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.

Analytic Thinking Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)

You may not qualify if:

  • Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
  • Hospitalization in past 3 months
  • Medication use that interferes with HPA-axis activity (e.g., corticosteroids)
  • Current oral contraceptive use
  • Current antibiotic, antiviral, or antimicrobial treatment
  • Travel outside the country within the past 6 months to any country on the CDC travel alert list
  • Recreational drug use, excessive alcohol or tobacco use
  • Significant experience with or daily practice of mindfulness meditation or related mind-body practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Lindsay EK, Young S, Creswell JD. Mindfulness training fosters a positive outlook during acute stress: A randomized controlled trial. Emotion. 2025 Jun;25(4):815-826. doi: 10.1037/emo0001452. Epub 2024 Nov 21.

    PMID: 39570681DERIVED

  • Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134.

    PMID: 30550321DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Emily K Lindsay, MS

    Carnegie Mellon University

    PRINCIPAL INVESTIGATOR

  • J. David Creswell, PhD

    Carnegie Mellon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 5, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)