Psychological StressNCT02502227
Mechanisms of Mindfulness Training and Stress Reduction
A study testing Mindfulness in people with Psychological Stress and Mindfulness, run by Carnegie Mellon University at 3 sites in United States.
Trial summary
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Mindfulness
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to Jan 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Moderate- to high-stress
- Owns an internet-enabled smart phone
Who cannot join
- Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
- Hospitalization in past 3 months
- Medication use that interferes with cortisol activity (e.g. corticosteroids)
- Current oral contraceptive use
- Pregnancy
- Current antibiotic, antiviral, or antimicrobial treatment
Show all 9Show fewer
- Travel outside the country within the past 6 months to any country on the Center for Disease Control 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
3 sites in 1 country.
United States3 sites
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center- Center for Integrative Medicine
Pittsburgh, Pennsylvania, 15232
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.
Read the detailed description
There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.
- Conditions
- Psychological Stress, Mindfulness
- Being tested
- Mindfulness
- Keywords
- mindfulness, psychological stress, wellness programs, 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.
MindfulnessBehavioural
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Active comparator | Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation Receives: Behavioral: Mindfulness |
| Mindful Attention Only Training | Active comparator | Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation Receives: Behavioral: Mindfulness |
| No Treatment Control Condition | No intervention | No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period. |
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 12 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 12 weeks
Subjective stress in response to social evaluative threat
Measured: assessed at post-intervention, which is an average of 14 weeks
Salivary Cortisol in response to social evaluative threat
Measured: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Measured: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
Sustained attention measured by the Dichotic Listening Task
Measured: change from baseline to post-intervention, which is an average of 14 weeks
Sustained inattentional blindness measured by the Inattentional Blindness Task
Measured: post-intervention only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Penn State University
- Responsible party
- Sponsor
- Investigators
- Wendy Weber, Ph.D., Study chair, National Center for Complementary and Integrative Health, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502227
- Sponsor's protocol ID
- 1R21AT008493-01A1
- Status last verified
- Jan 2017
- First submitted
- 7 Jul 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woods WC, Edershile EA, Ringwald WR, Sharpe BM, Himmelstein PH, Newman MG, Wilson SJ, Ellison WD, Levy KN, Pincus AL, Creswell JD, Wright AGC. Psychometric evaluation of a Visual Interpersonal Analog Scale. Psychol Assess. 2023 Apr;35(4):311-324. doi: 10.1037/pas0001210. Epub 2023 Jan 19.
PubMed 36656726Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial. J Exp Psychol Gen. 2021 Apr;150(4):686-699. doi: 10.1037/xge0000969. Epub 2020 Sep 24.
PubMed 32969686Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23.
PubMed 31120272Lindsay 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 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Mindfulness Training and Stress Reduction
- ClinicalTrials.gov ID
- NCT02502227
- Acronym / sponsor ID
- 1R21AT008493-01A1
- Conditions
- Psychological Stress, Mindfulness
- Keywords
- mindfulness, psychological stress, wellness programs, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Penn State University
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Jul 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.
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.
Detailed description
There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.
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: MindfulnessMindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation |
| Mindful Attention Only Training | Active comparator | Behavioral: MindfulnessMindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation |
| No Treatment Control Condition | No intervention | –No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Moderate- to high-stress
- Owns an internet-enabled smart phone
Key exclusion criteria (9 listed)
- Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
- Hospitalization in past 3 months
- Medication use that interferes with cortisol activity (e.g. corticosteroids)
- Current oral contraceptive use
- Pregnancy
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 |
|---|---|---|
| MindfulnessMindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience | Behavioural | Mindful Attention Only Training, Mindfulness 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 12 weeks
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 12 weeks
Subjective stress in response to social evaluative threat
Time frame: assessed at post-intervention, which is an average of 14 weeks
Salivary Cortisol in response to social evaluative threat
Time frame: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Time frame: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
Sustained attention measured by the Dichotic Listening Task
Time frame: change from baseline to post-intervention, which is an average of 14 weeks
Sustained inattentional blindness measured by the Inattentional Blindness Task
Time frame: post-intervention only
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 1 Feb 2017.
- Derived from this study: PubMed 36656726Woods WC, Edershile EA, Ringwald WR, Sharpe BM, Himmelstein PH, Newman MG, Wilson SJ, Ellison WD, Levy KN, Pincus AL, Creswell JD, Wright AGC. Psychometric evaluation of a Visual Interpersonal Analog Scale. Psychol Assess. 2023 Apr;35(4):311-324. doi: 10.1037/pas0001210. Epub 2023 Jan 19.
- Derived from this study: PubMed 32969686Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial. J Exp Psychol Gen. 2021 Apr;150(4):686-699. doi: 10.1037/xge0000969. Epub 2020 Sep 24.
- Derived from this study: PubMed 31120272Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23.
- 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.
Wendy Weber, Ph.D. study chair
National Center for Complementary and Integrative Health, National Institutes of Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Psychological Stress and Mindfulness, run by Carnegie Mellon University at 3 sites 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 3 inclusion and 9 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 12 weeks). 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 NCT02502227, which also lists 4 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 1 Feb 2017.