NCT07219095

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
43mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Nov 2025Nov 2029

First Submitted

Initial submission to the registry

August 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

August 25, 2025

Last Update Submit

October 16, 2025

Conditions

Keywords

danceself-compassion

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months

  • Self Compassion Scale (SCS) - Short Form questionnaire

    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

    enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months

Study Arms (2)

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.

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.

Interventions

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.

SuperBetter Arm

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Provision of informed consent (adult participant), or consent of parent/legal guardian in conjunction with adolescent assent (minor participant)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Related Publications (11)

  • 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.

    PMID: 26209145BACKGROUND
  • Gennarelli 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.

    PMID: 32186423BACKGROUND
  • Walter 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.

    PMID: 32439401BACKGROUND
  • Neff 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.

    PMID: 30124303BACKGROUND
  • Worthen-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.

    PMID: 28665690BACKGROUND
  • Psihogios 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.

    PMID: 33068424BACKGROUND
  • Semenchuk 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.

    PMID: 29580155BACKGROUND
  • Neff 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.

    PMID: 32125190BACKGROUND
  • Bantjes 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.

    PMID: 38714104BACKGROUND
  • Noh 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.

    PMID: 17365949BACKGROUND
  • van 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.

    PMID: 34803856BACKGROUND

MeSH Terms

Conditions

Ankle InjuriesFoot Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Emily O Cidambi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Concurrent mental health intervention with the SuperBetter app synchronously with physical therapy rehab from a lower extremity injury in dancers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

August 25, 2025

First Posted

October 21, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

November 15, 2029

Study Completion (Estimated)

November 15, 2029

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Likely not relevant or needed by other centers at this time

Locations