State AnxietyNCT05452629
Effect of Brief Mindfulness and Relaxation Inductions on Anxiety, Affect and Brain Activation in Athletes
A study testing Mindfulness induction (MI) and Relaxation (RI) in people with State Anxiety and Affect, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The athlete population has a high risk of suffering from mental health problems (e.g., anxiety), especially for athletes with individual sports. As such, various forms of mental training were used to maintain the mental health of athletes, such as mindfulness training or relaxation training. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- State Anxiety, Affect, Electroencephalography
- What is being tested?
- Mindfulness induction (MI) and Relaxation (RI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2020to 19 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- track and field athletes with regular training
- right-handedness
- no history of neurological illness
- no regular training experience in mindfulness or relaxation interventions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The athlete population has a high risk of suffering from mental health problems (e.g., anxiety), especially for athletes with individual sports. As such, various forms of mental training were used to maintain the mental health of athletes, such as mindfulness training or relaxation training. However, differences pertaining to the electrophysiological mechanisms resulting from both mental training in athletes are unknown. Therefore, the purpose of the current study was to examine the differential effects between the brief mindfulness induction (MI) and relaxation induction (RI) on state anxiety, affect and the activation of the brain in track and field athletes.
Read the detailed description
The purposes of this study are: (1) examining the effect of brief mindfulness induction (MI) and relaxation induction (RI) on anxiety and affect in athletes with individual sports, (2) and we sought to identify the different brain activity (i.e., theta, alpha) changes between MI and RI using EEG. In the present study, subjects were contrasted using a within-subject comparison across MI, RI, and control condition. According to past works on the comparison of mindfulness and psychological skill training, we hypothesized that MI and RI would both improve anxiety and affect, compared with control condition. Furthermore, we also hypothesized that RI would elicit greater theta power (i.e., more cognitive control) than MI. In addition, when compared with control condition, participants might be elicited greater alpha power during the MI and RI.
- Conditions
- State Anxiety, Affect, Electroencephalography
- Being tested
- Mindfulness induction (MI), Relaxation (RI)
- Keywords
- Mindfulness, Relaxation, Mental health, EEG, Cognitive resource
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness induction (MI)Behavioural
In the MI condition, participants were guided to focus on present experiences regarding the thoughts, emotions and sensations through the three classic mindfulness exercises (i.e., focused breathing, meditation, and body scanning). The duration of MI was 30-minutes.
Relaxation (RI)Behavioural
In the RI condition, participants were guided to relax each muscle group following the audio for 30-minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Induction | Experimental | A brief and single session of mindfulness practice for 30-minute. Receives: Behavioral: Mindfulness induction (MI) |
| Relaxation Induction | Experimental | A brief and single session of self-directed relaxation for 30-minute. Receives: Behavioral: Relaxation (RI) |
| Control Condition | No intervention | Open thinking. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety
The Chinese version of the State-Trait Anxiety Inventory (C-STAI, Wang \& Chung, 2016), which is based on the State-Trait Anxiety Inventory (STAI, Spielberger, 1970), was utilized to assess an individual's alteration of state anxiety before and after each experimental manipulation in current study. The State Anxiety Inventory (SAI) is a 20-item sub-scales in the STAI, with a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) used for each item. Higher total scores indicate higher levels of state anxiety.
Measured: 10 minutes
Affective state
The Positive and Negative Affect Schedule (PANAS) was utilized to assess an individual's alteration of PA and NA before and after each experimental manipulation in current study. PANAS is a 20-items questionnaire that consists of two 10-item mood scales assessing the positively affective states (i.e., PA) and negatively affective states (i.e., NA), respectively. Participants were asked to rate to what extent they felt a certain way right now from 1 (not at all) to 5 (extremely). Higher total scores indicate higher intensity of affective state.
Measured: 5 minutes
EEG
The selected frequency bands were as theta (4-8 Hz) and alpha (8-13 Hz), the frequency bands were computed by averaged across epochs and integrated spectral power, the frontal region (Fp1, Fp2, F7, F3, Fz, F4, F8) for theta power, and posterior region (P7, P3, Pz, P4, P8, O1, Oz, O2) for alpha power were selected into the statistical analysis, respectively.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 Jul 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for State AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a counterbalanced order, participants completed three conditions that incorporated two 30-minute experimental conditions (i.e., MI or RI) and a control condition (i.e., opened thinking)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Kai Chang, Ph.D., Study director, Department of Physical Education and Sport Sciences, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452629
- Sponsor's protocol ID
- PACNL_JT_MI_EEG
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brief Mindfulness and Relaxation Inductions on Anxiety, Affect and Brain Activation in Athletes
- ClinicalTrials.gov ID
- NCT05452629
- Acronym / sponsor ID
- PACNL_JT_MI_EEG
- Conditions
- State Anxiety, Affect, Electroencephalography
- Keywords
- Mindfulness, Relaxation, Mental health, EEG, Cognitive resource
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The athlete population has a high risk of suffering from mental health problems (e.g., anxiety), especially for athletes with individual sports. As such, various forms of mental training were used to maintain the mental health of athletes, such as mindfulness training or relaxation training. However, differences pertaining to the electrophysiological mechanisms resulting from both mental training in athletes are unknown. Therefore, the purpose of the current study was to examine the differential effects between the brief mindfulness induction (MI) and relaxation induction (RI) on state anxiety, affect and the activation of the brain in track and field athletes.
Detailed description
The purposes of this study are: (1) examining the effect of brief mindfulness induction (MI) and relaxation induction (RI) on anxiety and affect in athletes with individual sports, (2) and we sought to identify the different brain activity (i.e., theta, alpha) changes between MI and RI using EEG. In the present study, subjects were contrasted using a within-subject comparison across MI, RI, and control condition. According to past works on the comparison of mindfulness and psychological skill training, we hypothesized that MI and RI would both improve anxiety and affect, compared with control condition. Furthermore, we also hypothesized that RI would elicit greater theta power (i.e., more cognitive control) than MI. In addition, when compared with control condition, participants might be elicited greater alpha power during the MI and RI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In a counterbalanced order, participants completed three conditions that incorporated two 30-minute experimental conditions (i.e., MI or RI) and a control condition (i.e., opened thinking)
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Induction | Experimental | Behavioral: Mindfulness induction (MI)A brief and single session of mindfulness practice for 30-minute. |
| Relaxation Induction | Experimental | Behavioral: Relaxation (RI)A brief and single session of self-directed relaxation for 30-minute. |
| Control Condition | No intervention | –Open thinking. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- track and field athletes with regular training
- right-handedness
- no history of neurological illness
- no regular training experience in mindfulness or relaxation interventions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness induction (MI)In the MI condition, participants were guided to focus on present experiences regarding the thoughts, emotions and sensations through the three classic mindfulness exercises (i.e., focused breathing, meditation, and body scanning). The duration of MI was 30-minutes. | Behavioural | Mindfulness Induction |
| Relaxation (RI)In the RI condition, participants were guided to relax each muscle group following the audio for 30-minutes. | Behavioural | Relaxation Induction |
Primary outcome
State anxiety
Time frame: 10 minutes
The Chinese version of the State-Trait Anxiety Inventory (C-STAI, Wang \& Chung, 2016), which is based on the State-Trait Anxiety Inventory (STAI, Spielberger, 1970), was utilized to assess an individual's alteration of state anxiety before and after each experimental manipulation in current study. The State Anxiety Inventory (SAI) is a 20-item sub-scales in the STAI, with a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) used for each item. Higher total scores indicate higher levels of state anxiety.
Affective state
Time frame: 5 minutes
The Positive and Negative Affect Schedule (PANAS) was utilized to assess an individual's alteration of PA and NA before and after each experimental manipulation in current study. PANAS is a 20-items questionnaire that consists of two 10-item mood scales assessing the positively affective states (i.e., PA) and negatively affective states (i.e., NA), respectively. Participants were asked to rate to what extent they felt a certain way right now from 1 (not at all) to 5 (extremely). Higher total scores indicate higher intensity of affective state.
EEG
Time frame: 30 minutes
The selected frequency bands were as theta (4-8 Hz) and alpha (8-13 Hz), the frequency bands were computed by averaged across epochs and integrated spectral power, the frontal region (Fp1, Fp2, F7, F3, Fz, F4, F8) for theta power, and posterior region (P7, P3, Pz, P4, P8, O1, Oz, O2) for alpha power were selected into the statistical analysis, respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Kai Chang, Ph.D. study director
Department of Physical Education and Sport Sciences, National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness induction (MI) and Relaxation (RI) in people with State Anxiety and Affect, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.