Digital SPA: a smartphone program co-designed with teens and parents to help manage chronic pain
Official title: Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
Run by University of Malaga · NCT05917626 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 195 (estimated) |
| Sponsor | University of Malaga Academic / other |
| Locations | 6 sites (Almería, Almería and 5 other locations) |
| Status | Recruiting |
| Started | May 5, 2023 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT05917626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.