Dance Mental Health App
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of California, San Diego
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Mental Health App
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SuperBetter ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
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
Time frame
3, 6 and 12 months.Secondary outcomes
1
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.
Time frame
enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months2
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.
Time frame
enrollment, 3 months, 6 months, 12 months, 18 months, and 24 months3
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.
Time frame
enrollment, 3 months, 6 months, 12 months, 18 months, and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
Sanford Scholars Program Mentor Funding
Collaborator
Source ClinicalTrials.gov