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Not yet recruiting NCT06765200

Effectiveness of a Digital Treatment for Adolescents with Chronic Pain

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-administered psychosocial intervention delivered via smartphone..
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Research has shown that the prevalence of chronic pain in adolescents is high and increasing. These young people report significant changes in both their physical and psychological functioning. Currently, psychosocial treatments enjoy strong empirical support and are crucial to maintaining and improving the quality of life of adolescents suffering from chronic pain. However, the availability of these evidence-based interventions is insufficient to meet the high demand, especially outside of large cities. The aim of this project is to develop a digital treatment that helps improve the quality of life of adolescents with chronic pain and complementary websites for their parents and teachers.

Interventions

  • Behavioral Self-administered psychosocial intervention delivered via smartphone.
    The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain.

Primary outcome measures

  • Pain intensity [Time frame: baseline, 8 weeks, 3 months follow-up]
  • Pain interference [Time frame: baseline, 8 weeks, 3 months follow-up]
  • Global perception of change after treatment [Time frame: 8 weeks, 3 months follow-up]

Eligibility criteria

Inclusion criteria

  • 12-18 years old,
  • Having a non-oncology secondary chronic pain problem,
  • Having internet access,
  • A parent willing to participate in the study,
  • Providing informed consent/assent.

Exclusion criteria

  • Cognitive or language problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universitat Rovira i Virgili — Tarragona

Publications

  • Miro J, Sampietro A, Monterde S, Ingelmo P, Wicksell RK, Nolla C, Alonso M, Lazaro JJ, Martinez E, Rubio P, Sanchez A, Sanchez V, Vazquez A, de la Vega R, Reinoso-Barbero F. Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study. Front Digit Health. 2025 Jun 4;7:1555733. doi: 10.3389/fdgth.2025.1555733. eCollection 20 PMID 40534825

Identifiers

NCT: NCT06765200 · PID2022-142071OB-I00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗