Mechanisms of Mindfulness Training and Stress Reduction

Carnegie Mellon University

Status: Completed

Conditions: Psychological Stress; Mindfulness

Treatments: Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT02502227

1R21AT008493-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

137 participants in 3 patient groups

Mindfulness Training

Active Comparator group

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

Treatment:

Behavioral: Mindfulness

Mindful Attention Only Training

Active Comparator group

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

Treatment:

Behavioral: Mindfulness

No Treatment Control Condition

No Intervention group

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.