Clinical trial NCT02502227: Mechanisms of Mindfulness Training and Stress Reduction
Official title: Mechanisms of Mindfulness Training and Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Mindfulness
Keywords: mindfulness
psychological stress
wellness programs
cortisol
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Penn State University
First posted: 2015-07-20
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Daily life stress assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Secondary outcomes:
measure: Daily life state attention and acceptance assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
measure: Subjective stress in response to social evaluative threat
timeFrame: assessed at post-intervention, which is an average of 14 weeks
measure: Salivary Cortisol in response to social evaluative threat
timeFrame: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
measure: Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
timeFrame: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
measure: Sustained attention measured by the Dichotic Listening Task
timeFrame: change from baseline to post-intervention, which is an average of 14 weeks
measure: Sustained inattentional blindness measured by the Inattentional Blindness Task
timeFrame: post-intervention only
Other outcomes:
measure: Daily life affect assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
measure: Daily life social interactions assessed via Ecological Momentary Assessment
timeFrame: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
measure: Perceived stress using the Perceived Stress Scale
timeFrame: change from baseline to post-intervention, which is an average of 14 weeks
measure: Attentional control using the Attentional Control Scale
timeFrame: change from baseline to post-intervention, which is an average of 14 weeks
measure: Treatment expectancies
timeFrame: post-intervention an average of 14 weeks after the baseline
measure: Subjective responses to the training program intervention
timeFrame: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
measure: Mindfulness using the Mindful Attention Awareness Scale
timeFrame: change from baseline to post-intervention, which is an average of 14 weeks
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center- Center for Integrative Medicine
state: Pennsylvania
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: National Center for Complementary and Integrative Health, National Institutes of Health
name: Wendy Weber, Ph.D.
role: STUDY_CHAIR
References:
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.
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.
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.