Mechanisms of Mindfulness Training and Stress Reduction

Mindfulness Clinical Trial

Official title:

Mechanisms of Mindfulness Training and Stress Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502227
• Other study ID #: 1R21AT008493-01A1
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: January 30, 2017
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness
• Psychological Stress
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center- Center for Integrative Medicine	Pittsburgh	Pennsylvania
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Carnegie Mellon University	Penn State University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Perceived stress using the Perceived Stress Scale		change from baseline to post-intervention, which is an average of 14 weeks
Other	Attentional control using the Attentional Control Scale		change from baseline to post-intervention, which is an average of 14 weeks
Other	Treatment expectancies		post-intervention an average of 14 weeks after the baseline
Other	Subjective responses to the training program intervention		composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
Other	Mindfulness using the Mindful Attention Awareness Scale		change from baseline to post-intervention, which is an average of 14 weeks
Primary	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	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
Secondary	Subjective stress in response to social evaluative threat		assessed at post-intervention, which is an average of 14 weeks
Secondary	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
Secondary	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
Secondary	Sustained attention measured by the Dichotic Listening Task		change from baseline to post-intervention, which is an average of 14 weeks
Secondary	Sustained inattentional blindness measured by the Inattentional Blindness Task		post-intervention only