Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients (Digital SPA)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Digital SPA

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 Type: Interventional
• Enrollment (Estimated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocio de la Vega, PhD; Phone Number: +34634014362; Email: rocio.delavega@uma.es

Study Locations

• Spain
  • Almería
    • Almería, Almería, Spain, 04009
      • Recruiting
      • Hospital Materno Infantil Torrecardenas
      • Contact: Moisés Leyva, MD; Phone Number: +34634014362; Email: moises.leyva.sspa@juntadeandalucia.es
  • Barcelona
    • Barcelona, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Déu
      • Contact: Iván Cano Cámara, MD; Phone Number: +34634014362; Email: ivan.cano@sjd.es
  • Granada
    • Granada, Granada, Spain, 18014
      • Recruiting
      • Hospital Materno Infantil Virgen de las Nieves
      • Contact: Susana Roldán, MD; Phone Number: +34634014362; Email: sroldanaparicio@gmail.com
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Recruiting
      • Hospital infantil del Hospital Universitario La Paz
      • Contact: Eduardo Fernández, PhD; Phone Number: +34634014362; Email: eduferjim.psyc@gmail.com
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Recruiting
      • Hospital General Universitario Santa Lucía
      • Contact: Maria Luz Padilla, MD; Phone Number: +34634014362; Email: mariluzpadilladelrey@gmail.com
      • Contact: María Cases, MD; Email: maria.cases.s12@gmail.com
  • Málaga
    • Málaga, Málaga, Spain, 29006
      • Recruiting
      • Hospital Materno Infantil del Hospital Regional Universitario
      • Contact: Silvia Oliva, MD; Phone Number: +34634014362; Email: silviaolivarp@gmail.com
      • Contact: María José Peláez, MD; Email: pelaez_mariajose@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Diagnosis of a comorbid serious health condition (e.g., cancer)
• Parent or child does not speak or read Spanish
• Active psychosis or suicidal ideation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital SPA; A psychological intervention for chronic pain in adolescents administered using an app co-created with patients.	Behavioral: Digital SPA; 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.
No Intervention: Usual Care; Participants assigned to this arm will receive usual care from their hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).
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.	From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks.
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.	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.	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.	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.	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.	Post-treatment (T3; 8 weeks after T1).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (side effects)	Adverse Events are not expected given the content of the treatment and its non-invasive nature, however, they will be assessed, recorded and controlled for in the analyses	Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Ministerio de Ciencia e Innovación, Spain
• Investigators: Principal Investigator: Rocio de la Vega, PhD, University of Malaga

Publications and helpful links

General 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.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Implementation; Chronic pain; Psychological Intervention; Digital Health; Co-development
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: PID2021-122885OA-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No