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Mechanisms of Mindfulness Training and Stress Reduction

Primary Purpose

Psychological Stress, Mindfulness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychological Stress focused on measuring mindfulness, psychological stress, wellness programs, cortisol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking
  • Moderate- to high-stress
  • Owns an internet-enabled smart phone

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Carnegie Mellon University
  • University of Pittsburgh Medical Center- Center for Integrative Medicine
  • Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Mindfulness Training

Mindful Attention Only Training

No Treatment Control Condition

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Daily life stress assessed via Ecological Momentary Assessment

Secondary Outcome Measures

Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Subjective stress in response to social evaluative threat
Salivary Cortisol in response to social evaluative threat
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Sustained attention measured by the Dichotic Listening Task
Sustained inattentional blindness measured by the Inattentional Blindness Task

Full Information

First Posted
July 7, 2015
Last Updated
January 30, 2017
Sponsor
Carnegie Mellon University
Collaborators
University of Pittsburgh, Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT02502227
Brief Title
Mechanisms of Mindfulness Training and Stress Reduction
Official Title
Mechanisms of Mindfulness Training and Stress Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carnegie Mellon University
Collaborators
University of Pittsburgh, Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Mindfulness
Keywords
mindfulness, psychological stress, wellness programs, cortisol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Training
Arm Type
Active Comparator
Arm Description
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
Arm Title
Mindful Attention Only Training
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Treatment Control Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Subjective stress in response to social evaluative threat
Time Frame
assessed at post-intervention, which is an average of 14 weeks
Title
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
Title
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
Title
Sustained attention measured by the Dichotic Listening Task
Time Frame
change from baseline to post-intervention, which is an average of 14 weeks
Title
Sustained inattentional blindness measured by the Inattentional Blindness Task
Time Frame
post-intervention only
Other Pre-specified Outcome Measures:
Title
Daily life affect 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
Title
Daily life social interactions 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
Title
Perceived stress using the Perceived Stress Scale
Time Frame
change from baseline to post-intervention, which is an average of 14 weeks
Title
Attentional control using the Attentional Control Scale
Time Frame
change from baseline to post-intervention, which is an average of 14 weeks
Title
Treatment expectancies
Time Frame
post-intervention an average of 14 weeks after the baseline
Title
Subjective responses to the training program intervention
Time Frame
composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
Title
Mindfulness using the Mindful Attention Awareness Scale
Time Frame
change from baseline to post-intervention, which is an average of 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking Moderate- to high-stress Owns an internet-enabled smart phone Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Weber, Ph.D.
Organizational Affiliation
National Center for Complementary and Integrative Health, National Institutes of Health
Official's Role
Study Chair
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Medical Center- Center for Integrative Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32969686
Citation
Chin 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.
Results Reference
derived
PubMed Identifier
31120272
Citation
Chin 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.
Results Reference
derived
PubMed Identifier
30550321
Citation
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.
Results Reference
derived

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Mechanisms of Mindfulness Training and Stress Reduction

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