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

Chronic Pain Clinical Trial

— Digital SPA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05917626
• Other study ID #: PID2021-122885OA-I00
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 (adolescents) or a website (parents).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Digital SPA
A psychological digital intervention for chronic pain in adolescents, based on evidence-based cognitive-behavioral and 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.

Locations

Country	Name	City	State
Spain	Hospital Materno Infantil Torrecardenas	Almería
Spain	Hospital Sant Joan de Déu	Barcelona
Spain	Hospital General Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital Materno Infantil Virgen de las Nieves	Granada
Spain	Hospital infantil del Hospital Universitario La Paz	Madrid
Spain	Hospital Materno Infantil del Hospital Regional Universitario	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	Change in Emotional Distress	The Spanish version of the Patient-Reported Outcomes Measurement Information System (PROMIS) emotional distress scale will be administered to assess anxiety and depression symptoms. The anxiety scale is scored in a 1 ("never") to 5 ("always") scale, with higher scores indicating more anxiety symptoms. The depression scale is scored in a 1 ("never") to 5 ("always") scale, with higher scores indicating more depression 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).
Secondary	Change in Functional Disability	The Spanish version of the Functional Disability Inventory for adolescents (FDI) will be administered. 0 "No trouble" to 4 "Impossible". The total FDI score can range from 0 to 60, with higher scores indicating higher levels of disability.	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	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).
Secondary	Change in Self-efficacy	Self-Efficacy Questionnaire for Children (SEQ-C). The perception of self-management skills after treatment will be assessed with this questionnaire. Each item has to be scored on a 5-point scale between 1 "not at all" and 5 "very well". Total scores range from 21 to 105, with higher scores indicating more self-efficacy.	Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).
Secondary	Satisfaction with treatment	The Treatment Evaluation Inventory will be administered. It ranges from 0 to 35, with higher scores indicating more satisfaction with the treatment.	Post-treatment (T3; 8 weeks after T1).
Secondary	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.

External Links

•   Project website