NCT06765200

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
19mo left

Started Oct 2025

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress28%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

December 19, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

December 19, 2024

Last Update Submit

January 2, 2025

Conditions

Chronic Pain

Keywords

chronic painmhealthadolescentmobile application

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Refers to the severity of pain an individual experiences, measured on a scale (0-10)

    baseline, 8 weeks, 3 months follow-up

  • Pain interference

    Refers to the extent to which pain affects an individual's daily life and functioning. Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference will be used (0-32; 0=no interference, 32=intense interference).

    baseline, 8 weeks, 3 months follow-up

  • Global perception of change after treatment

    refers to an individual's overall assessment of how their condition has improved or worsened following a treatment, measured on a scale (0-10).

    8 weeks, 3 months follow-up

Study Arms (1)

Digital treatment

EXPERIMENTAL

The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain.

Behavioral: Self-administered psychosocial intervention delivered via smartphone.

Interventions

Self-administered psychosocial intervention delivered via smartphone.BEHAVIORAL

The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain.

Digital treatment

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive or language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Rovira i Virgili

Tarragona, Spain

Location

Related Publications (1)

  • 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 2025.

    PMID: 40534825DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jordi Miró

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariadna Sampietro

CONTACT

+34 977558471ariadna.sampietro@urv.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 9, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

ES(1)