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NCT Number: NCT06765200

Effectiveness of a Digital Treatment for Adolescents with Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Rovira i Virgili

Tarragona, Spain

Location contact

Ariadna Sampietro

CONTACT

Helena Garriga

CONTACT

Jordi Miró

CONTACT

María Isabel Salvat

CONTACT

Pere Llorens

CONTACT

Sampietro

CONTACT

[email protected]

+34 977 55 84 71

Sonia Monterde

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ariadna Sampietro

CONTACT

[email protected]

+34 977558471

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

  • Ministry of Science and Innovation, Spain

Registry information

Acronym: DigiDOL-Ad

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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