Effectiveness of a Digital Treatment for Adolescents with Chronic Pain (DigiDOL-Ad)

January 2, 2025 updated by: Jordi Miró, University Rovira i Virgili
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Tarragona, Spain
        • Universitat Rovira i Virgili
        • Contact:
        • Contact:
          • Jordi Miró
        • Contact:
          • Ariadna Sampietro
        • Contact:
          • Pere Llorens
        • Contact:
          • Helena Garriga
        • Contact:
          • Sonia Monterde
        • Contact:
          • María Isabel Salvat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital treatment
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.
The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: baseline, 8 weeks, 3 months follow-up
Refers to the severity of pain an individual experiences, measured on a scale (0-10)
baseline, 8 weeks, 3 months follow-up
Pain interference
Time Frame: baseline, 8 weeks, 3 months follow-up
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
Time Frame: 8 weeks, 3 months follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rovira i Virgili

Collaborators

Ministry of Science and Innovation, Spain

Investigators

  • Principal Investigator: Jordi Miró, University Rovira i Virgili

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID2022-142071OB-I00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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