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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05612295
Other study ID # PACNL_MBPP_Stress
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 31, 2023
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source National Taiwan Normal University
Contact Yu-Kai Chang, Ph.D.
Phone +8862-7749-3223
Email yukaichangnew@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Considering that increased competition levels are typically accompanied by elevated stress and anxiety, athletes' ability to cope with stress has gained even more importance in recent years. Growing evidence has demonstrated the effectiveness of mindfulness in reducing stress and enhancing athletic performance; however, its effectiveness remains a matter of debate and limitations due to absence of more rigorous designs, ecological validity, and randomized controlled trials. Accordingly, the current trial, entitled Mindfulness-based Peak Performance (MBPP), will take an interdisciplinary approach (e.g., sport psychology, sports training, and cognitive neuroscience), to more definitively examine whether a tailored mindfulness-based intervention (MBI) affects athletic performance under pressure and relevant mental attributes. Specifically, this study is an 8-week, three-arm, randomized controlled trial (RCT), and eligible participants will be randomly assigned into (1) an MBPP group (MBPP), (2) a self-talk group (ST), and (3) a wait-list control group (WC). The primary outcomes (e.g., endurance performance under pressure, performance-relevant mental attributes) and secondary outcomes (e.g., dispositional mindfulness, sports psychological skills) will be assessed before and after intervention. The MBPP and ST are expected that will improve performance under pressure, but MBPP might show greater improvement than ST. Additionally, MBPP is expected that will improve performance-relevant mental attributes. The results from this trial might provide rigorous evidence and insight into MBI application in the sports context.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
MBPP
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.
Self-talk
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.

Locations

Country Name City State
Taiwan Department of Physical Education and Sport Sciences, National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 General dispositional mindfulness The general dispositional mindfulness will be assessed by Chinese version of the Mindful Attention Awareness Scale (C-MAAS)(Chang et al., 2011), which is modified from the original Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003). Higher scores reflect higher levels of general dispositional mindfulness. 5 minutes each at the Baseline-Assessment and at the Post-Assessment
Secondary Athletic dispositional mindfulness Athletic mindfulness will be measured by the Athlete Mindfulness Questionnaire (AMQ; Zhang et al., 2017). Higher scores reflect higher levels of athletic dispositional mindfulness. 5 minutes each at the Baseline-Assessment and at the Post-Assessment
Secondary Athletic psychological skills Athletic psychological skill levels will be assessed using the Athletic Psychological Skill Inventory (APSI) (Chiou and Chi, 2001), which is a modified Chinese version of Athletic Coping Skills Inventory-28 (ACSI-28; Smith et al., 1995). 5 minutes each at the Baseline-Assessment and at the Post-Assessment
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