Psychological StressNCT02433431
Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
A study testing Mindfulness Training, Mindful Attention Only Training and Analytic Thinking Training in people with Psychological Stress and Mindfulness, run by Carnegie Mellon University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychological Stress, Mindfulness
- What is being tested?
- Mindfulness Training, Mindful Attention Only Training and Analytic Thinking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers.
The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training.
Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.
- Conditions
- Psychological Stress, Mindfulness
- Being tested
- Mindfulness Training, Mindful Attention Only Training, Analytic Thinking Training
- Keywords
- mindfulness, psychological stress, immune marker, wellness programs, mobile applications, cortisol
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Mindfulness 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 TrainingBehavioural
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.
Analytic Thinking TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Active comparator | 14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance Receives: Behavioral: Mindfulness Training |
| Mindful Attention Only Training | Active comparator | 14-lesson audio-guided mindfulness training program instructing present-moment attention only Receives: 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 Receives: Behavioral: Analytic Thinking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily life stress assessed via Ecological Momentary Assessment
Measured: 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).
Measured: 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
Measured: 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)
Measured: assessed at post-intervention, which is an average of 3.5 weeks
Salivary Cortisol AUC in response to social evaluative threat (TSST)
Measured: 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)
Measured: assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session
Evening salivary cortisol
Measured: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Sustained attention measured by the Dichotic Listening Task
Measured: change from baseline to post-intervention, which is an average of 3.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, Yoga Science Foundation, Penn State University, University of Pittsburgh, Virginia Commonwealth University, 01 Expert Systems, LLC
- Responsible party
- Principal investigator, Emily Lindsay, Carnegie Mellon University
- Investigators
- Emily K Lindsay, MS, Principal investigator, Carnegie Mellon UniversityJ. David Creswell, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433431
- Sponsor's protocol ID
- IRBSTUDY2015_00000122
- Status last verified
- May 2016
- First submitted
- 23 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39570681Lindsay 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.
PubMed 30550321
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
- ClinicalTrials.gov ID
- NCT02433431
- Acronym / sponsor ID
- IRBSTUDY2015_00000122
- Conditions
- Psychological Stress, Mindfulness
- Keywords
- mindfulness, psychological stress, immune marker, wellness programs, mobile applications, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts, Yoga Science Foundation, Penn State University, University of Pittsburgh, Virginia Commonwealth University, 01 Expert Systems, LLC
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers.
The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training.
Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Active comparator | Behavioral: Mindfulness Training14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance |
| Mindful Attention Only Training | Active comparator | Behavioral: Mindful Attention Only Training14-lesson audio-guided mindfulness training program instructing present-moment attention only |
| Analytic Thinking Training | Active comparator | Behavioral: Analytic Thinking Training14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingMindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period. | Behavioural | Mindfulness Training |
| Mindful Attention Only TrainingMindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period. | Behavioural | Mindful Attention Only Training |
| Analytic Thinking TrainingComparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period. | Behavioural | Analytic Thinking Training |
Primary outcome
Daily life stress assessed via Ecological Momentary Assessment
Time frame: 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
Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks
Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).
6 secondary outcomes
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Time frame: 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)
Time frame: assessed at post-intervention, which is an average of 3.5 weeks
Salivary Cortisol AUC in response to social evaluative threat (TSST)
Time frame: 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)
Time frame: assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session
Evening salivary cortisol
Time frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Sustained attention measured by the Dichotic Listening Task
Time frame: change from baseline to post-intervention, which is an average of 3.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 39570681Lindsay 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.
- Derived from this study: PubMed 30550321Lindsay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K Lindsay, MS principal investigator
Carnegie Mellon University
J. David Creswell, PhD principal investigator
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training, Mindful Attention Only Training and Analytic Thinking Training in people with Psychological Stress and Mindfulness, run by Carnegie Mellon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily life stress assessed via Ecological Momentary Assessment (time frame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.