Digital SPA: a smartphone program co-designed with teens and parents to help manage chronic pain
Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
This project will test whether a smartphone app co-designed with teens and parents helps adolescents 12–17 with chronic pain manage pain and improve daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | University of Malaga Academic / other |
| Locations | 6 sites (Almería, Almería and 5 other locations) |
| Trial ID | NCT05917626 on ClinicalTrials.gov |
What this trial studies
This multi-phase project will co-design a smartphone app (Digital SPA) with patients, parents, and clinicians using focus groups and interviews, then create content and perform usability testing. The app’s content will follow WHO guidance and use evidence-based psychological techniques, primarily Cognitive Behavioral Therapy and Acceptance and Commitment Therapy, to teach skills like relaxation, sleep management, goal setting, behavioral activation, and coping with negative thoughts. In Phase 3, 195 adolescents (12–17 years) and one parent each across several Spanish hospitals will try the app while completing questionnaires and outcome measures to test effectiveness and implementation. The study combines qualitative feedback, usage data, and clinical outcomes to refine the intervention and support broader clinical adoption.
Who should consider this trial
Good fit: Ideal candidates are Spanish-speaking adolescents aged 12–17 with non-oncologic chronic pain for at least three months who have internet access and a parent willing to participate.
Not a fit: Patients with serious comorbid medical conditions (for example cancer), active psychosis or suicidal ideation, those who do not read Spanish, or those without internet-capable smartphones are unlikely to benefit from this app-based intervention.
Why it matters
Potential benefit: If successful, Digital SPA could teach teens coping skills that reduce pain-related disability and improve day-to-day functioning while being scalable across clinics.
How similar studies have performed: Previous digital CBT and ACT programs for pediatric chronic pain have shown promising results, although fully co-designed, multi-center implementation apps are still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents age 12-17 years * Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain) * Has Internet access * One parent is willing to participate (and both give consent for their child to participate) Exclusion Criteria: * Diagnosis of a comorbid serious health condition (e.g., cancer) * Parent or child does not speak or read Spanish * Active psychosis or suicidal ideation
Where this trial is running
Almería, Almería and 5 other locations
- Hospital Materno Infantil Torrecardenas — Almería, Almería, Spain (Recruiting)
- Hospital Sant Joan de Déu — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Materno Infantil Virgen de las Nieves — Granada, Granada, Spain (Recruiting)
- Hospital infantil del Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
- Hospital General Universitario Santa Lucía — Cartagena, Murcia, Spain (Recruiting)
- Hospital Materno Infantil del Hospital Regional Universitario — Málaga, Málaga, Spain (Recruiting)
Study contacts
- Principal investigator: Rocio de la Vega, PhD — University of Malaga
- Study coordinator: Rocio de la Vega, PhD
- Email: rocio.delavega@uma.es
- Phone: +34634014362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.