Mechanisms of Mindfulness Training and Stress Reduction

NCT02502227 | Completed DMC

• 1 other identifier: 1R21AT008493-01A1
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 3

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.

Conditions

Psychological Stress; Mindfulness

Keywords

mindfulness; psychological stress; wellness programs; cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (7)

• 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

Study Arms (3)

Mindfulness Training

ACTIVE COMPARATOR

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

Mindful Attention Only Training

ACTIVE COMPARATOR

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 Treatment Control Condition

NO INTERVENTION

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.

Interventions

Mindfulness BEHAVIORAL

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

Mindful Attention Only Training; Mindfulness Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carnegie Mellon University: lead
• University of Pittsburgh: collaborator
• Penn State University: collaborator

Study Sites (3)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center- Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

• Woods WC, Edershile EA, Ringwald WR, Sharpe BM, Himmelstein PH, Newman MG, Wilson SJ, Ellison WD, Levy KN, Pincus AL, Creswell JD, Wright AGC. Psychometric evaluation of a Visual Interpersonal Analog Scale. Psychol Assess. 2023 Apr;35(4):311-324. doi: 10.1037/pas0001210. Epub 2023 Jan 19.

  PMID: 36656726 DERIVED

• 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.

  PMID: 32969686 DERIVED

• 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.

  PMID: 31120272 DERIVED

• 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.

  PMID: 30550321 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wendy Weber, Ph.D.

  National Center for Complementary and Integrative Health, National Institutes of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (3)