Mechanisms of Mindfulness Training and Stress Reduction

Sponsor

Carnegie Mellon University (Other)

Overall Status

Completed

CT.gov ID

NCT02502227

Collaborator

University of Pittsburgh (Other), Penn State University (Other)

137

Enrollment

Locations

Arms

18.1

Duration (Months)

45.7

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Stress Mindfulness	Behavioral: Mindfulness	N/A

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

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Mechanisms of Mindfulness Training and Stress Reduction

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mindfulness Training 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	Behavioral: Mindfulness 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
Active Comparator: Mindful Attention Only Training 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	Behavioral: Mindfulness 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
No Intervention: No Treatment Control Condition 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.

Arm

Intervention/Treatment

Active Comparator: Mindfulness Training

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

Behavioral: Mindfulness

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

Active Comparator: Mindful Attention Only Training

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

Behavioral: Mindfulness

No Intervention: No Treatment Control Condition

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.

Outcome Measures

Primary Outcome Measures

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 12 weeks]

Secondary Outcome Measures

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 12 weeks]
Subjective stress in response to social evaluative threat [assessed at post-intervention, which is an average of 14 weeks]
Salivary Cortisol in response to social evaluative threat [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) [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 [change from baseline to post-intervention, which is an average of 14 weeks]
Sustained inattentional blindness measured by the Inattentional Blindness Task [post-intervention only]

Other Outcome Measures

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 12 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 12 weeks]
Perceived stress using the Perceived Stress Scale [change from baseline to post-intervention, which is an average of 14 weeks]
Attentional control using the Attentional Control Scale [change from baseline to post-intervention, which is an average of 14 weeks]
Treatment expectancies [post-intervention an average of 14 weeks after the baseline]
Subjective responses to the training program intervention [composite of ratings made after each intervention lesson, an average of 10 weeks following baseline]
Mindfulness using the Mindful Attention Awareness Scale [change from baseline to post-intervention, which is an average of 14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carnegie Mellon University	Pittsburgh	Pennsylvania	United States	15213
2	University of Pittsburgh Medical Center- Center for Integrative Medicine	Pittsburgh	Pennsylvania	United States	15232
3	Pennsylvania State University	University Park	Pennsylvania	United States	16802