Chronic PainDigital SPANCT05917626
Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
A study testing Digital SPA in people with Chronic Pain, run by University of Malaga at 6 sites in Spain.
Trial summary
Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Digital SPA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 6 sitesSpain
- Study dates
- 5 May 2023to Oct 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents age 12-17 years
- Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
- Has Internet access
- One parent is willing to participate (and both give consent for their child to participate)
Who cannot join
- Diagnosis of a comorbid serious health condition (e.g., cancer)
- Parent or child does not speak or read Spanish
- Active psychosis or suicidal ideation
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Materno Infantil Torrecardenas
Almería, Almería, 04009
Moisés Leyva, MD, +34634014362, moises.leyva.sspa@juntadeandalucia.es
- Recruiting
Hospital Sant Joan de Déu
Barcelona, Barcelona, 08950
Iván Cano Cámara, MD, +34634014362, ivan.cano@sjd.es
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Maria Luz Padilla, MD, +34634014362, mariluzpadilladelrey@gmail.com
María Cases, MD, maria.cases.s12@gmail.com
- Recruiting
Hospital Materno Infantil Virgen de las Nieves
Granada, Granada, 18014
Susana Roldán, MD, +34634014362, sroldanaparicio@gmail.com
- Recruiting
Hospital infantil del Hospital Universitario La Paz
Madrid, Madrid, 28046
Eduardo Fernández, PhD, +34634014362, eduferjim.psyc@gmail.com
- Recruiting
Hospital Materno Infantil del Hospital Regional Universitario
Málaga, Málaga, 29006
Silvia Oliva, MD, +34634014362, silviaolivarp@gmail.com
María José Peláez, MD, pelaez_mariajose@hotmail.com
About this study
Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood.
The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability.
Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app.
Read the detailed description
Phase 1) Focus groups with patients, parents and clinicians (n = 5-6 each) will inform about unmet pain care needs, and provide a starting point for co-designing the intervention.
Phase 2) Content creation and usability testing will be based on the results of Phase 1 and the theory-driven development will follow the latest available evidence and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills.
Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.
- Conditions
- Chronic Pain
- Being tested
- Digital SPA
- Keywords
- Chronic pain, Adolescents, Digital Health, Psychological Intervention, Co-development, Implementation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital SPABehavioural
A psychological digital intervention for chronic pain in adolescents, based on evidence-based Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet.
| Study group | Role | What they receive |
|---|---|---|
| Digital SPA | Experimental | A psychological intervention for chronic pain in adolescents administered using an app co-created with patients. Receives: Behavioral: Digital SPA |
| Usual Care | No intervention | Participants assigned to this arm will receive usual care from their hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference
Spanish version of the Brief Pain Inventory (BPI) short version. Pain intensity scale scores range from from 0 to 10 , with higher scores indicating greater interference. Interference scores range from 0 to 10, with higher scores indicating greater interference.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Global impression of change after treatment
11-point scale (0 to 10) with higher scores indicating greater impression of change.
Measured: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in the number of visits to the Emergency Room (ER) due to pain
The number of visits to the ER due to pain during the follow-up period (T3 to T4; 3 months) will be compared with the three months before starting treatment (T1).
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Secondary outcomes (10)
Change in pain readiness to change
Readiness to adopt a self-management approach to pain. The Spanish version of the Pain Stages of Change Questionnaire for Adolescents (PSoCQ-A). The Questionnaire has three scales: Pre-contemplation, Contemplation, and Action/Maintenance. Each scale is scored in a 1 to 5 Likert scale, with higher scores indicating a higher level of attitudes in that stage of change. The scale with the highest score indicates which stage the respondent is at.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in the dose of pain medication taken
The dose (eg. 25 mg per day) of pain medication taken will be recorded.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in the type of pain medication taken
The type (e.g. Non-steroid Anti-inflammatory Drugs, opioids) of pain medication taken will be recorded.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Emotional Distress
The Spanish version of the Social Emotional Distress Scale-Secondary (SEDS-S) will be administered to assess general emotional distress (internalizing symptoms such as anxiety and depression) over the past month. The SEDS-S is a 10-item self-report questionnaire; items are rated from 1 ("Not at all true") to 4 ("Very true / Absolutely true"), with higher total scores indicating greater emotional distress.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Functional Disability
Spanish version of CALI-9. Disability in functioning due to pain (activity limitations) is measured through 9 items to evaluate pain-related activity limitations in youth with chronic pain. Scores range from 1 = not very difficult; to 5 = extremely difficult. Higher scores indicating greater interference with children's activities.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Sleep
Sleep quality will be assessed with the Spanish version of the Pittsburgh Sleep Quality Index, validated for adolescents (PSQI). Scores on 7 components range from 0 to 3, and are the summed (global score range 0 to 21, with higher scores indicating worse sleep quality).
Insomnia will be assessed with the Spanish version of the Adolescent Insomnia Questionnaire (AIQ). Total scores range from 0 to 52 with higher scores indicating more insomnia symptoms.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Pain Self-efficacy
Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item self-report measure that evaluates the extent to which individuals feel capable of functioning despite their pain. Items are rated on a 7-point scale from 0 ("not at all confident") to 6 ("completely confident"). Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
Measured: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Psychological Flexibility and Inflexibility Processes
Psychological flexibility and inflexibility will be assessed using the Multidimensional Psychological Flexibility Inventory (MPFI). The MPFI includes subscales capturing both flexibility and inflexibility across six ACT processes. Items are rated on a 1 ("never true") to 6 ("always true") scale. Subscale scores are computed by summing item responses, with higher scores indicating greater levels of the corresponding process (higher flexibility or higher inflexibility). A global index of psychological flexibility will also be measured using the PsyFlex questionnaire. The PsyFlex consists of 6 items rated on a 1 ("very untrue of me") to 5 ("very true of me") scale. Total scores range from 6 to 30, with higher scores indicating greater psychological flexibility.
Measured: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Satisfaction with treatment
Usability and satisfaction with the intervention will be assessed using the mHealth App Usability Questionnaire (MAUQ). The MAUQ includes 18 items rated on a 1 ("strongly disagree") to 7 ("strongly agree") scale. Subscales assess ease of use, interface and satisfaction, and usefulness. Higher scores indicate greater usability and satisfaction with the digital intervention.
Measured: Post-treatment (T3; 8 weeks after T1).
Adherence to treatment
One measure of implementation will be adherence to the online intervention assessed collecting back-end data such as: number of log-ins or number of treatment sections completed.
Measured: From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start5 May 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study will employ a stepped wedge cluster randomized design in which hospitals are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 6 hospitals will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the hospital.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Rocio de la Vega de Carranza, PhD, University of Malaga
- Investigators
- Rocio de la Vega, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917626
- Sponsor's protocol ID
- PID2021-122885OA-I00
- Acronym
- Digital SPA
- Status last verified
- Dec 2025
- First submitted
- 8 May 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de la Vega R, Serrano-Ibanez ER, Ruiz-Parraga GT, Palermo TM, Wicksell R, Fernandez-Jimenez E, Oliva S, Roldan S, Monfort L, Pelaez MJ, Leyva Carmona M, Ramirez-Maestre C, Lopez-Martinez AE, Miro J, Esteve R. Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA). Digit Health. 2023 Dec 19;9:20552076231219490. doi: 10.1177/20552076231219490. eCollection 2023 Jan-Dec.
PubMed 38130799
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients
- ClinicalTrials.gov ID
- NCT05917626
- Acronym / sponsor ID
- Digital SPA / PID2021-122885OA-I00
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Adolescents, Digital Health, Psychological Intervention, Co-development, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 5 May 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Jun 2023 (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.
Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood.
The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability.
Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app.
Detailed description
Phase 1) Focus groups with patients, parents and clinicians (n = 5-6 each) will inform about unmet pain care needs, and provide a starting point for co-designing the intervention.
Phase 2) Content creation and usability testing will be based on the results of Phase 1 and the theory-driven development will follow the latest available evidence and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills.
Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will employ a stepped wedge cluster randomized design in which hospitals are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 6 hospitals will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the hospital.
| Arm | Type | Receives |
|---|---|---|
| Digital SPA | Experimental | Behavioral: Digital SPAA psychological intervention for chronic pain in adolescents administered using an app co-created with patients. |
| Usual Care | No intervention | –Participants assigned to this arm will receive usual care from their hospital. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents age 12-17 years
- Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
- Has Internet access
- One parent is willing to participate (and both give consent for their child to participate)
Key exclusion criteria (3 listed)
- Diagnosis of a comorbid serious health condition (e.g., cancer)
- Parent or child does not speak or read Spanish
- Active psychosis or suicidal ideation
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 |
|---|---|---|
| Digital SPAA psychological digital intervention for chronic pain in adolescents, based on evidence-based Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet. | Behavioural | Digital SPA |
Primary outcome
Change in Pain Interference
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Spanish version of the Brief Pain Inventory (BPI) short version. Pain intensity scale scores range from from 0 to 10 , with higher scores indicating greater interference. Interference scores range from 0 to 10, with higher scores indicating greater interference.
Global impression of change after treatment
Time frame: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
11-point scale (0 to 10) with higher scores indicating greater impression of change.
Change in the number of visits to the Emergency Room (ER) due to pain
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
The number of visits to the ER due to pain during the follow-up period (T3 to T4; 3 months) will be compared with the three months before starting treatment (T1).
10 secondary outcomes
Change in pain readiness to change
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in the dose of pain medication taken
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in the type of pain medication taken
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Emotional Distress
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Functional Disability
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Sleep
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Change in Pain Self-efficacy
Time frame: Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Psychological Flexibility and Inflexibility Processes
Time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Satisfaction with treatment
Time frame: Post-treatment (T3; 8 weeks after T1).
Adherence to treatment
Time frame: From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.
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 15 Dec 2025.
- Background: PubMed 38130799de la Vega R, Serrano-Ibanez ER, Ruiz-Parraga GT, Palermo TM, Wicksell R, Fernandez-Jimenez E, Oliva S, Roldan S, Monfort L, Pelaez MJ, Leyva Carmona M, Ramirez-Maestre C, Lopez-Martinez AE, Miro J, Esteve R. Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA). Digit Health. 2023 Dec 19;9:20552076231219490. doi: 10.1177/20552076231219490. eCollection 2023 Jan-Dec.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rocio de la Vega, PhD principal investigator
University of Malaga
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital SPA in people with Chronic Pain, run by University of Malaga at 6 sites 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Rocio de la Vega, PhD (+34634014362, rocio.delavega@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Interference (time frame: Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).). 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 NCT05917626, 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 15 Dec 2025.