NCT05612295

Brief Summary

The primary aim of this study is to conduct a well-designed trial to investigate the effect of an MBI program entitled Mindfulness-based Peak Performance (MBPP) on endurance performance under pressure from an interdisciplinary approach of sport psychology, sports training, and cognitive neuroscience. The secondary aim is to examine the effect of MBPP program on performance-relevant mental attributes in behavioral and neurocognitive assessments. The present study hypothesizes that the MBPP and self-talk groups will improve performance under pressure, but MBPP is expected to show greater improvement than ST. Additionally, we expect the MBPP will improve the relevant mental attributes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

November 1, 2022

Last Update Submit

March 15, 2026

Conditions

Keywords

mindfulness interventionsport performance under pressureNeurocognitive function

Outcome Measures

Primary Outcomes (10)

  • Endurance performance: Change in time to exhaustion

    Time to exhaustion (TTE) will be one of the measured variables of endurance performance and be evaluated via a graded exercise test (GXT) on a motor-driven treadmill.

    30 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Endurance performance: Change in maximum oxygen consumption

    Maximum oxygen consumption (VO2max) will be one of the measured variables of endurance performance and be evaluated via a computerized indirect calorimetry system throughout the whole graded exercise test (GXT) on a motor-driven treadmill.

    30 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Endocrine stress responses

    Before and after pressure manipulation, and after endurance performance measure, stress responses of endocrine assessments will be assessed. Specifically, salivary cortisol (sCort) and salivary alpha-amylases (sAA) will be collected using the commercially available sampling devices.

    1 minutes for each sampling

  • Subjective stress responses

    The participants' subjective perception of stress will be assessed via the Chinese version of the State-Trait Anxiety Inventory (C-STAI) (Wang and Chung, 2016) modified from the original version of STAI (Spielberger et al., 1971). The state subscale of the STAI will be the index of state anxiety influenced by pressure manipulation.

    5 minutes for each assessment

  • Change in emotion regulation

    The Chinese version of the Difficulties in Emotion Regulation Scale (C-DERS) modified from DERS (Gratz and Roemer, 2004) will be used to assess emotional regulation. C-DERS is a 36-item self-reported questionnaire to measure the six facets of emotional regulation (i.e., awareness, clarity, impulse, goal, non-acceptance, and strategies). Items are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always).

    10 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Engagement

    Participants' engagement will be an adherence score calculated by addition of the Z scores for overall participant attendance of MBPP/ST sessions and a Z score for overall participant minutes spent on home practice, then divided by the total Z scores. Researchers will record the attendance of each participant in MBPP or ST programs.

    5 minutes at the Post-Assessment

  • Executive function: Change in reaction time

    The executive function in terms of reaction time will be assessed by the computerized Stroop Test. The types of trials are the three Chinese color words printed in one of the three types of color. Based on the combination of words and the pixels of the color, there are three types of trials: (1) congruent trials: the stimuli in which the color of the word corresponds to the semantic meaning of the word; (2) incongruent trials: the stimuli in which the paint color of the word is inconsistent with the semantic meaning of the word; and (3) neutral trials: the colored squared.

    30 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Executive function: Change in accuracy

    The executive function in terms of accuracy will also be assessed by the computerized Stroop Test. The types of trials are the three Chinese color words printed in one of the three types of color. Based on the combination of words and the pixels of the color, there are three types of trials: (1) congruent trials: the stimuli in which the color of the word corresponds to the semantic meaning of the word; (2) incongruent trials: the stimuli in which the paint color of the word is inconsistent with the semantic meaning of the word; and (3) neutral trials: the colored squared.

    30 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Change in attention

    The attention will be measured by event-related potential while Stroop Test.

    30 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Change in brain resting state

    The frequency domain of electroencephalography (EEG) will also be recorded during the resting state at baseline and post-intervention.

    8 minutes each at the Baseline-Assessment and at the Post-Assessment

Secondary Outcomes (3)

  • General dispositional mindfulness

    5 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Athletic dispositional mindfulness

    5 minutes each at the Baseline-Assessment and at the Post-Assessment

  • Athletic psychological skills

    5 minutes each at the Baseline-Assessment and at the Post-Assessment

Study Arms (3)

MBPP group

EXPERIMENTAL

The Mindfulness-based Peak Performance (MBPP) program consists of eight 60-min training sessions, once weekly for 8 weeks, which aim to enhance human performance.

Behavioral: MBPP

Self-talk group

ACTIVE COMPARATOR

The self-talk intervention serving as the active control group will be included in the current trial. In line with the MBPP intervention, the self-talk intervention is also designed to enhance athletic performance, and will consist of eight 60-min meaningful sessions, once per week for eight weeks.

Behavioral: Self-talk

Waiting-list control

NO INTERVENTION

The participants in waiting-list control group are advised to maintain their everyday lifestyles and regular training. Once the participants in WC finish the experiment, they will be invited to participate in one of the 8-week interventions (i.e., MBPP or ST) based upon their preference.

Interventions

MBPPBEHAVIORAL

MBPP program consist of three fundamental principles (i.e., attention monitoring, acceptance, sport-specific rationale) and six performance-related core mental attributes including three behavioral and three neurocognitive components. Each session will start with a brief homework discussion and recap of the preceding session, and instructors will deliver a topic-related brief story or group activity to participants, followed by a theoretical introduction and practice of mindfulness. Finally, at the end of each session, instructors will guide participant to discuss mindfulness applications related to specific sports performances. At the end of the session, participants will be assigned homework to increase the effectiveness of MBPP, and participants will be encouraged to practice daily for at least 10-15 min between the sessions.

Also known as: Mindfulness-based intervention
MBPP group
Self-talkBEHAVIORAL

self-talk sessions include: Session 1 \& 2. The concepts, types, and the importance of self-talk will be introduced; Session 3. Researchers, coaches and the athletes will work together to design syntactically recognizable, concise, and clear sport-specific instructional scripts for specific sports performance (e.g., running); Session 4. practice of sport-specific instructional self-talk; Session 5. researchers, coaches and the athletes will work together to design syntactically recognizable, concise, and clear sport-specific motivational self-talk scripts for specific sports performances; Session 6. practice of sport-specific motivational self-talk; and Session 7 \& 8. general practice for learned self-talk techniques.

Self-talk group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 30 years
  • Normal or corrected-to-normal 20/20 vision
  • No red-green color blindness
  • Able to speak and read Chinese
  • Physical Activity Readiness Questionnaire (PAR-Q) score = 0
  • With one of the designated sport proficiencies (i.e., middle-long running, marathon, triathlon)
  • No previous major experience in mindfulness-related training (e.g., meditation or Tai Chi)
  • Provide informed consent

You may not qualify if:

  • Diagnosed or self-reported cognitive problems
  • The diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
  • Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
  • History of alcohol or drug abuse
  • Unwillingness to be randomized to one of the three groups
  • Currently participating in another study trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Sciences, National Taiwan Normal University

Taipei, 106308, Taiwan

Location

Related Publications (1)

  • Chang YK, Gill DL, Creswell JD, Chen DT, Lin CY, Chu CH, Nien JT. Effect of mindfulness-based intervention on endurance performance under pressure and performance-relevant mental attributes, an interdisciplinary perspective: Protocol for a Mindfulness-Based Peak Performance (MBPP) trial. Contemp Clin Trials. 2023 Jun;129:107175. doi: 10.1016/j.cct.2023.107175. Epub 2023 Apr 5.

Study Officials

  • Yu-Kai Chang, Ph.D.

    Department of Physical Education and Sport Sciences, National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 10, 2022

Study Start

September 5, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data are available upon request.

Locations