Psychological Well-BeingNCT06212986
Enhancing Psychological Skills and Well-being in Sport Through a Blended Intervention: a Controlled Study With Perform-UP Tennis
A study testing Promotion of mental training through mobile application Perform-UP Tennis in people with Psychological Well-Being, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Mental preparation is a fundamental aspect of athletic performance. The investigators present here an experiment aimed at evaluating the effectiveness of a blended intervention to promote mindfulness and self-confidence and a reduction of anxiety among professional athletes. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being
- What is being tested?
- Promotion of mental training through mobile application Perform-UP Tennis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2021to 30 Apr 2022
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being tennis players with a minimum age of 14
- being fluent in Italian
- having a smartphone with an Internet connection
Who cannot join
- having hearing difficulties
- not playing tennis
- being younger than 14 years old
- not having a good knowledge of Italian
Trial locations and contacts
1 site in 1 country.
About this study
Mental preparation is a fundamental aspect of athletic performance. The investigators present here an experiment aimed at evaluating the effectiveness of a blended intervention to promote mindfulness and self-confidence and a reduction of anxiety among professional athletes. Perform-UP Tennis is an application that provides a weekly mental training program to be integrated into the athlete's daily routine. The intervention included eight weekly modules with variable and progressive training and relaxation exercises. Meetings with the athletes took place every 2 weeks. The study involved 41 tennis players who were randomly assigned to either the intervention or the control group.
- Conditions
- Psychological Well-Being
- Being tested
- Promotion of mental training through mobile application Perform-UP Tennis
- Keywords
- mobile app, psychological well-being, sport, tennis players
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of mental training through mobile application Perform-UP TennisDevice
Perform-UP Tennis is a sport specific mental training app that integrates breathing, relaxation and na-ture-based guided imagery exercises and aims to promote emotional well-being and the enhancement of mental skills. The app techniques are integrated into a single gradual path that involves increasingly complex breathing and relaxation exercises with increasing duration.
The intervention consists of eight weekly modules over a period of 8 weeks with progressive exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental blended group | Experimental | The experimental blended group (perform-up group) used the application Perform-UP Tennis on their own and also met up with a professional sports psychologist every 2 weeks for debriefing. Participants were asked to answer a series of questionnaires in two separate phases. Receives: Device: Promotion of mental training through mobile application Perform-UP Tennis |
| Control group | No intervention | Participants were asked to answer a series of questionnaires in two separate phases, but they only carried out their classic technical training without integrating the mental training program with the app Perform-UP Tennis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychological Inventory of Sport Performance (IPPS-48) was used to assess athletes' mental abilities. The questionnaire included 48 items, divided into eight subscales each reflecting eight mental abilities.
Each scale included five items, to which the athletes responded on a 5-point Likert scale. The eight subscales reflected the following eight mental abilities: concentration, arousal control, preparation of the match, goal setting, visualization, cognitive anxiety, self-confidence and self-talk. But for this research, the investigators considered only three subscales that were consistent with the activities proposed within the application (breathing and relaxation techniques). The scales considered were: cognitive anxiety, which evaluates the athlete's level of concern during the match, fear of making mistakes, and fear of failing, self-confidence, which evaluates the confidence that the athlete has in being able to compete at his/her best, to give their best and to believe in themselves, emotional arousal control, which evaluates the athlete's ability to relax when he/she feels anxious and under tension and to activate him/herself when he/she needs to reach the right energy level.
Measured: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
The Mindfulness Inventory for Sport (MIS) was used to evaluate the awareness processes within the athlete's sports performance. The scale consists of 15 items reflecting three distinct components of mindfulness.
Each scale included five items, to which the athletes responded on a 5-point Likert scale. It contains both positively and negatively worded items (the non-judgmental subscale was reverse-scored). Specifically, this questionnaire assessed: (1) Awareness, being aware of stimuli and their associated internal reactions, (2) non-judgmental, adopting a non-judgmental attitude towards these stimuli and reactions, (3) refocusing, quickly refocus attention on target signals.
Measured: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start30 Apr 2021
- Primary completion30 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Well-BeingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Villani, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212986
- Sponsor's protocol ID
- 4221_2021
- Status last verified
- Feb 2024
- First submitted
- 23 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bordo S, Costanzo G, Villani D. Enhancing psychological skills and well-being in sport through an app-based blended intervention: a randomized controlled pilot study. BMC Psychol. 2025 May 21;13(1):537. doi: 10.1186/s40359-025-02824-8.
PubMed 40400025
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Psychological Skills and Well-being in Sport Through a Blended Intervention: a Controlled Study With Perform-UP Tennis
- ClinicalTrials.gov ID
- NCT06212986
- Acronym / sponsor ID
- 4221_2021
- Conditions
- Psychological Well-Being
- Keywords
- mobile app, psychological well-being, sport, tennis players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jan 2024 (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.
Mental preparation is a fundamental aspect of athletic performance. The investigators present here an experiment aimed at evaluating the effectiveness of a blended intervention to promote mindfulness and self-confidence and a reduction of anxiety among professional athletes. Perform-UP Tennis is an application that provides a weekly mental training program to be integrated into the athlete's daily routine. The intervention included eight weekly modules with variable and progressive training and relaxation exercises. Meetings with the athletes took place every 2 weeks. The study involved 41 tennis players who were randomly assigned to either the intervention or the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental blended group | Experimental | Device: Promotion of mental training through mobile application Perform-UP TennisThe experimental blended group (perform-up group) used the application Perform-UP Tennis on their own and also met up with a professional sports psychologist every 2 weeks for debriefing. Participants were asked to answer a series of questionnaires in two separate phases. |
| Control group | No intervention | –Participants were asked to answer a series of questionnaires in two separate phases, but they only carried out their classic technical training without integrating the mental training program with the app Perform-UP Tennis. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- being tennis players with a minimum age of 14
- being fluent in Italian
- having a smartphone with an Internet connection
Key exclusion criteria (4 listed)
- having hearing difficulties
- not playing tennis
- being younger than 14 years old
- not having a good knowledge of Italian
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 |
|---|---|---|
| Promotion of mental training through mobile application Perform-UP TennisPerform-UP Tennis is a sport specific mental training app that integrates breathing, relaxation and na-ture-based guided imagery exercises and aims to promote emotional well-being and the enhancement of mental skills. The app techniques are integrated into a single gradual path that involves increasingly complex breathing and relaxation exercises with increasing duration. The intervention consists of eight weekly modules over a period of 8 weeks with progressive exercises. | Device | Experimental blended group |
Primary outcome
The Psychological Inventory of Sport Performance (IPPS-48) was used to assess athletes' mental abilities. The questionnaire included 48 items, divided into eight subscales each reflecting eight mental abilities.
Time frame: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
Each scale included five items, to which the athletes responded on a 5-point Likert scale. The eight subscales reflected the following eight mental abilities: concentration, arousal control, preparation of the match, goal setting, visualization, cognitive anxiety, self-confidence and self-talk. But for this research, the investigators considered only three subscales that were consistent with the activities proposed within the application (breathing and relaxation techniques). The scales considered were: cognitive anxiety, which evaluates the athlete's level of concern during the match, fear of making mistakes, and fear of failing, self-confidence, which evaluates the confidence that the athlete has in being able to compete at his/her best, to give their best and to believe in themselves, emotional arousal control, which evaluates the athlete's ability to relax when he/she feels anxious and under tension and to activate him/herself when he/she needs to reach the right energy level.
The Mindfulness Inventory for Sport (MIS) was used to evaluate the awareness processes within the athlete's sports performance. The scale consists of 15 items reflecting three distinct components of mindfulness.
Time frame: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)
Each scale included five items, to which the athletes responded on a 5-point Likert scale. It contains both positively and negatively worded items (the non-judgmental subscale was reverse-scored). Specifically, this questionnaire assessed: (1) Awareness, being aware of stimuli and their associated internal reactions, (2) non-judgmental, adopting a non-judgmental attitude towards these stimuli and reactions, (3) refocusing, quickly refocus attention on target signals.
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 13 Feb 2024.
- Derived from this study: PubMed 40400025Bordo S, Costanzo G, Villani D. Enhancing psychological skills and well-being in sport through an app-based blended intervention: a randomized controlled pilot study. BMC Psychol. 2025 May 21;13(1):537. doi: 10.1186/s40359-025-02824-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of mental training through mobile application Perform-UP Tennis in people with Psychological Well-Being, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 inclusion and 4 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 13 Feb 2024. 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 Italy. 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?
The Psychological Inventory of Sport Performance (IPPS-48) was used to assess athletes' mental abilities. The questionnaire included 48 items, divided into eight subscales each reflecting eight mental abilities. (time frame: It was assessed at baseline (T0) and after eight weeks, which is at the end of the intervention (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212986, which also lists 1 linked publication.
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 13 Feb 2024.