Chronic PainDigiDOL-AdNCT06765200
Effectiveness of a Digital Treatment for Adolescents with Chronic Pain
A study testing Self-administered psychosocial intervention delivered via smartphone. in people with Chronic Pain, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-administered psychosocial intervention delivered via smartphone.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Cognitive or language problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universitat Rovira i Virgili
Tarragona
Sampietro, +34 977 55 84 71, ariadna.sampietro@urv.cat
Jordi Miró
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Self-administered psychosocial intervention delivered via smartphone.
- Keywords
- chronic pain, mhealth, adolescent, mobile application
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered psychosocial intervention delivered via smartphone.Behavioural
The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Digital treatment | Experimental | The treatment includes a smartphone-based psychosocial program designed to improve the quality of life of adolescents with chronic pain. Receives: Behavioral: Self-administered psychosocial intervention delivered via smartphone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Refers to the severity of pain an individual experiences, measured on a scale (0-10)
Measured: 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).
Measured: 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).
Measured: 8 weeks, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study startOct 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Jordi Miró, University Rovira i Virgili
- Investigators
- Jordi Miró, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765200
- Sponsor's protocol ID
- PID2022-142071OB-I00
- Acronym
- DigiDOL-Ad
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 2025.
PubMed 40534825
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Treatment for Adolescents with Chronic Pain
- ClinicalTrials.gov ID
- NCT06765200
- Acronym / sponsor ID
- DigiDOL-Ad / PID2022-142071OB-I00
- Conditions
- Chronic Pain
- Keywords
- chronic pain, mhealth, adolescent, mobile application
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital treatment | Experimental | 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Cognitive or language problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Digital treatment |
Primary outcome
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)
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 40534825Miro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordi Miró principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered psychosocial intervention delivered via smartphone. in people with Chronic Pain, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariadna Sampietro (+34 977558471, ariadna.sampietro@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: baseline, 8 weeks, 3 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.