Ankle InjuryNCT07219095
Dance Mental Health App
A study testing Mental Health App in people with Ankle Injury and Foot Injury, run by University of California, San Diego at 1 site in United States.
Trial summary
This project aims to enhance self-compassion in adolescent dancers recovering from a foot and ankle injury by incorporating the use of a mental health intervention app using gamified design during their recovery. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Ankle Injury, Foot Injury, Lower Extremity Injury
- What is being tested?
- Mental Health App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 15 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of informed consent (adult participant), or consent of parent/legal guardian in conjunction with adolescent assent (minor participant)
- 13 to 18 years of age
- Endorses dance as their primary sport, or participates 3 days per week or greater in dance prior to injury
- Stated willingness to comply with all study procedures including the intervention regimen and availability for the duration of the study
- Access to a device with which the SuperBetter app can be downloaded and used
Who cannot join
- Dance is not a primary sport or less than 3 days per week spent dancing prior to injury (skater, gymnast, other sport)
- Requiring surgery or prior surgery for the injury being treated
- Injury outside of the leg below the knee
- Known eating disorder or bone density issue (documented abnormal Z score and/or eating disorder diagnosis upon review of the medical chart)
- Verbalized plans to not return to dance after recovery from the injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
Macy J Dexter, 858-576-1700 ext. 224451, mdexter1@rchsd.org
About this study
Official title: Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial
This project aims to enhance self-compassion in adolescent dancers recovering from a foot and ankle injury by incorporating the use of a mental health intervention app using gamified design during their recovery.
- Conditions
- Ankle Injury, Foot Injury, Lower Extremity Injury
- Being tested
- Mental Health App
- Keywords
- dance, self-compassion
- Medical subject headings
- Ankle Injuries, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health AppDevice
Participants will use the SuperBetter mobile app to participate in gamified mental health activities 5 days per week, 10 minutes per day, for 12 weeks alongside their physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| SuperBetter Arm | Experimental | Those randomized into the treatment group will be completing gamified mental health exercises in an app called SuperBetter for 10 minutes, 5 days per week, for 12 weeks alongside physical therapy. Receives: Device: Mental Health App |
| Control Arm | No intervention | Those randomized into the observation group need only attend their physical therapy appointments and complete the questionnaires but will not use the mental health app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (or percentage) of participants who have returned to full, unrestricted dance after injury
Will be assessed as part of the clinical exam by asking current return to dance status
Measured: 3, 6 and 12 months.
Secondary outcomes (3)
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures of Pediatric Anxiety, Depressive Symptoms, Pain Interference, and Mobility questionnaire
PROMIS scores for Emotional distress (anxiety and depression) and Pain interference subscales. Higher score and higher standard deviation from the norm are considered poorer function/worse outcomes.
Measured: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Self Compassion Scale (SCS) - Short Form questionnaire
1 is the lowest possible overall calculated score, and the highest overall calculated score is 5, with greater scores indicating greater level of self-compassion.
Measured: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living subscale and Sports Subscale questionnaire
Minimum calculated score for each subscale is 0% and highest score is 100% with the higher score meaning better function.
Measured: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuryStudies 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
- Parallel groups
- Model description
- Concurrent mental health intervention with the SuperBetter app synchronously with physical therapy rehab from a lower extremity injury in dancers
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Sanford Scholars Program Mentor Funding
- Responsible party
- Principal investigator, Emily Cidambi, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219095
- Sponsor's protocol ID
- 812643
- Status last verified
- Oct 2025
- First submitted
- 25 Aug 2025
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Likely not relevant or needed by other centers at this time
Publications
Christino MA, Fantry AJ, Vopat BG. Psychological Aspects of Recovery Following Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2015 Aug;23(8):501-9. doi: 10.5435/JAAOS-D-14-00173.
PubMed 26209145Gennarelli SM, Brown SM, Mulcahey MK. Psychosocial interventions help facilitate recovery following musculoskeletal sports injuries: a systematic review. Phys Sportsmed. 2020 Nov;48(4):370-377. doi: 10.1080/00913847.2020.1744486. Epub 2020 Mar 25.
PubMed 32186423Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.
PubMed 32439401Neff KD, Toth-Kiraly I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, Guo HX, Hirsch JK, Hupfeld J, Hutz CS, Kotsou I, Lee WK, Montero-Marin J, Sirois FM, de Souza LK, Svendsen JL, Wilkinson RB, Mantzios M. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: Support for use of a total score and six subscale scores. Psychol Assess. 2019 Jan;31(1):27-45. doi: 10.1037/pas0000629. Epub 2018 Aug 20.
PubMed 30124303Worthen-Chaudhari L, McGonigal J, Logan K, Bockbrader MA, Yeates KO, Mysiw WJ. Reducing concussion symptoms among teenage youth: Evaluation of a mobile health app. Brain Inj. 2017;31(10):1279-1286. doi: 10.1080/02699052.2017.1332388. Epub 2017 Jun 30.
PubMed 28665690Psihogios AM, Stiles-Shields C, Neary M. The Needle in the Haystack: Identifying Credible Mobile Health Apps for Pediatric Populations during a Pandemic and beyond. J Pediatr Psychol. 2020 Nov 1;45(10):1106-1113. doi: 10.1093/jpepsy/jsaa094.
PubMed 33068424Semenchuk BN, Strachan SM, Fortier M. Self-Compassion and the Self-Regulation of Exercise: Reactions to Recalled Exercise Setbacks. J Sport Exerc Psychol. 2018 Feb 1;40(1):31-39. doi: 10.1123/jsep.2017-0242. Epub 2018 Mar 26.
PubMed 29580155Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3.
PubMed 32125190Bantjes J, Hunt X, Cuijpers P, Kazdin AE, Kennedy CJ, Luedtke A, Malenica I, Petukhova M, Sampson N, Zainal NH, Davids C, Dunn-Coetzee M, Gerber R, Stein DJ, Kessler RC. Comparative effectiveness of remote digital gamified and group CBT skills training interventions for anxiety and depression among college students: Results of a three-arm randomised controlled trial. Behav Res Ther. 2024 Jul;178:104554. doi: 10.1016/j.brat.2024.104554. Epub 2024 May 3.
PubMed 38714104Noh YE, Morris T, Andersen MB. Psychological intervention programs for reduction of injury in ballet dancers. Res Sports Med. 2007 Jan-Mar;15(1):13-32. doi: 10.1080/15438620600987064.
PubMed 17365949van Winden D, van Rijn RM, Savelsbergh GJP, Oudejans RRD, Stubbe JH. The Association Between Stress and Injury: A Prospective Cohort Study Among 186 First-Year Contemporary Dance Students. Front Psychol. 2021 Nov 5;12:770494. doi: 10.3389/fpsyg.2021.770494. eCollection 2021.
PubMed 34803856
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Mental Health App in the Recovery of Adolescent Dancers From a Lower Extremity Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07219095
- Acronym / sponsor ID
- 812643
- Conditions
- Ankle Injury, Foot Injury, Lower Extremity Injury
- Keywords
- dance, self-compassion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Sanford Scholars Program Mentor Funding
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 21 Oct 2025 (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.
This project aims to enhance self-compassion in adolescent dancers recovering from a foot and ankle injury by incorporating the use of a mental health intervention app using gamified design during their recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Concurrent mental health intervention with the SuperBetter app synchronously with physical therapy rehab from a lower extremity injury in dancers
| Arm | Type | Receives |
|---|---|---|
| SuperBetter Arm | Experimental | Device: Mental Health AppThose randomized into the treatment group will be completing gamified mental health exercises in an app called SuperBetter for 10 minutes, 5 days per week, for 12 weeks alongside physical therapy. |
| Control Arm | No intervention | –Those randomized into the observation group need only attend their physical therapy appointments and complete the questionnaires but will not use the mental health app. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Provision of informed consent (adult participant), or consent of parent/legal guardian in conjunction with adolescent assent (minor participant)
- 13 to 18 years of age
- Endorses dance as their primary sport, or participates 3 days per week or greater in dance prior to injury
- Stated willingness to comply with all study procedures including the intervention regimen and availability for the duration of the study
- Access to a device with which the SuperBetter app can be downloaded and used
Key exclusion criteria (5 listed)
- Dance is not a primary sport or less than 3 days per week spent dancing prior to injury (skater, gymnast, other sport)
- Requiring surgery or prior surgery for the injury being treated
- Injury outside of the leg below the knee
- Known eating disorder or bone density issue (documented abnormal Z score and/or eating disorder diagnosis upon review of the medical chart)
- Verbalized plans to not return to dance after recovery from the injury
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 |
|---|---|---|
| Mental Health AppParticipants will use the SuperBetter mobile app to participate in gamified mental health activities 5 days per week, 10 minutes per day, for 12 weeks alongside their physical therapy. | Device | SuperBetter Arm |
Primary outcome
Number (or percentage) of participants who have returned to full, unrestricted dance after injury
Time frame: 3, 6 and 12 months.
Will be assessed as part of the clinical exam by asking current return to dance status
3 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures of Pediatric Anxiety, Depressive Symptoms, Pain Interference, and Mobility questionnaire
Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Self Compassion Scale (SCS) - Short Form questionnaire
Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living subscale and Sports Subscale questionnaire
Time frame: enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Background: PubMed 26209145Christino MA, Fantry AJ, Vopat BG. Psychological Aspects of Recovery Following Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2015 Aug;23(8):501-9. doi: 10.5435/JAAOS-D-14-00173.
- Background: PubMed 32186423Gennarelli SM, Brown SM, Mulcahey MK. Psychosocial interventions help facilitate recovery following musculoskeletal sports injuries: a systematic review. Phys Sportsmed. 2020 Nov;48(4):370-377. doi: 10.1080/00913847.2020.1744486. Epub 2020 Mar 25.
- Background: PubMed 32439401Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.
- Background: PubMed 30124303Neff KD, Toth-Kiraly I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, Guo HX, Hirsch JK, Hupfeld J, Hutz CS, Kotsou I, Lee WK, Montero-Marin J, Sirois FM, de Souza LK, Svendsen JL, Wilkinson RB, Mantzios M. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: Support for use of a total score and six subscale scores. Psychol Assess. 2019 Jan;31(1):27-45. doi: 10.1037/pas0000629. Epub 2018 Aug 20.
- Background: PubMed 28665690Worthen-Chaudhari L, McGonigal J, Logan K, Bockbrader MA, Yeates KO, Mysiw WJ. Reducing concussion symptoms among teenage youth: Evaluation of a mobile health app. Brain Inj. 2017;31(10):1279-1286. doi: 10.1080/02699052.2017.1332388. Epub 2017 Jun 30.
- Background: PubMed 33068424Psihogios AM, Stiles-Shields C, Neary M. The Needle in the Haystack: Identifying Credible Mobile Health Apps for Pediatric Populations during a Pandemic and beyond. J Pediatr Psychol. 2020 Nov 1;45(10):1106-1113. doi: 10.1093/jpepsy/jsaa094.
- Background: PubMed 29580155Semenchuk BN, Strachan SM, Fortier M. Self-Compassion and the Self-Regulation of Exercise: Reactions to Recalled Exercise Setbacks. J Sport Exerc Psychol. 2018 Feb 1;40(1):31-39. doi: 10.1123/jsep.2017-0242. Epub 2018 Mar 26.
- Background: PubMed 32125190Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3.
- Background: PubMed 38714104Bantjes J, Hunt X, Cuijpers P, Kazdin AE, Kennedy CJ, Luedtke A, Malenica I, Petukhova M, Sampson N, Zainal NH, Davids C, Dunn-Coetzee M, Gerber R, Stein DJ, Kessler RC. Comparative effectiveness of remote digital gamified and group CBT skills training interventions for anxiety and depression among college students: Results of a three-arm randomised controlled trial. Behav Res Ther. 2024 Jul;178:104554. doi: 10.1016/j.brat.2024.104554. Epub 2024 May 3.
- Background: PubMed 17365949Noh YE, Morris T, Andersen MB. Psychological intervention programs for reduction of injury in ballet dancers. Res Sports Med. 2007 Jan-Mar;15(1):13-32. doi: 10.1080/15438620600987064.
- Background: PubMed 34803856van Winden D, van Rijn RM, Savelsbergh GJP, Oudejans RRD, Stubbe JH. The Association Between Stress and Injury: A Prospective Cohort Study Among 186 First-Year Contemporary Dance Students. Front Psychol. 2021 Nov 5;12:770494. doi: 10.3389/fpsyg.2021.770494. eCollection 2021.
- Individual participant dataSharing planned: No. Likely not relevant or needed by other centers at this time
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health App in people with Ankle Injury and Foot Injury, run by University of California, San Diego at 1 site in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Oct 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily O Cidambi, MD (858-576-1700, ecidambi@rchsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number (or percentage) of participants who have returned to full, unrestricted dance after injury (time frame: 3, 6 and 12 months.). 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 NCT07219095, which also lists 11 linked publications.
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 21 Oct 2025.