Cultivating Activity, Commitment, Tolerance & Uplift Study - for Children With Chronic Pain

NCT07485426 | Enrolling By Invitation

• 1 other identifier: 2024-06066-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the addition of physical exercise and mindfulness training, delivered by a mobile application, to multimodal pain rehabilitation could lead to a mor effective rehabilitation process and improved outcomes. The main questions it aims to answer are: Does 6 weeks of app-based physical exercise and mindfulness in combination with 6 weeks of multimodal hospital based pain rehabilitation give inferior results compared to 12 weeks of multimodal hospital based pain rehabilitation? Thus the study is an inferiority trial of a scaled down pain rehabilitation period with the addition of physical exercise and mindfulness training done at home with directions from a mobile application. Participants randomized into the active intervention will begin training for 6 weeks with the app, and continue through out the rehabilitation period. Those randomized into the control group will immediately begin pain rehabilitation as usual. All participants will wear an accelerometer bracelet for a week, before, in the middle and after the 12 week study period, and fill out a questionnaire and training logs.

Conditions

Chronic Pain

Keywords

Physical exercise; Mindfulness; Mobile Health; Pain rehabiliation

Outcome Measures

Primary Outcomes (1)

• Work And Social Adjustment Scale - Youth & Parents [WASAS-Y/P]

  Questionnarie mesuring level of fuction in major life domains (eg school, family, friends). 5 items. High scores represent more funciontional impairment. Min = 0, Max = 40.

  At baseline, at 6 weeks, 12 weeks, and 1 year.

Secondary Outcomes (3)

• Revised Child Anxiety and Depression Scale - Youth & Parents [RCADS-Y/P] 48 item version.

  At baseline, at 6 weeks, 12 weeks, and 1 year.

• Pain Catastrophizing Scale-Children & Parents [PCS-C/P]

  At baseline, at 6 weeks, 12 weeks, and 1 year.

• Accelerometer-based phystical activity (moderate to vigorous physical acvitity, MVPA)

  At baseline, at 6 weeks, 12 weeks, and 1 year.

Study Arms (2)

Intervention arm - 6 weeks of mobile home exercise and mindfulness training

EXPERIMENTAL

6 weeks of mobile home exercise and mindfulness training in addition to 6 weeks of hospital-based multimodal pain rehabilitation

Behavioral: Mobile-based physical exercise and mindfulness training

Control arm - 12 weeks of hospital-based multimodal pain rehabilitation

ACTIVE COMPARATOR

12 week of hospital-based multimodal pain rehabilitation.

Behavioral: Pain rehabilitation as usual (PRAU)

Interventions

Mobile-based physical exercise and mindfulness training BEHAVIORAL

6 weeks of daily physical exercise and mindfulness training supported by a mobile application, as well as continous during an additational 6 weeks of multimodal hospital-based pain rehabilitation.

Intervention arm - 6 weeks of mobile home exercise and mindfulness training

Pain rehabilitation as usual (PRAU) BEHAVIORAL

12 weeks of multimodal hospital-based pain rehabilitation.

Control arm - 12 weeks of hospital-based multimodal pain rehabilitation

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13-19 years
• The presence of long-term pain (\>3 months) and a great deal of suffering or an affected level of function.
• Ability to read in Swedish
• Access to a mobile phone or tablet with internet connection

You may not qualify if:

• Low motivation
• Severe mental illness
• Contraindications for physical activity (medical)

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58185, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researcher handling data, computing and interpreting results will be blinded to allocation of patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant in Pediatrics, Senior Lecturer

Model Details: Non-blinded randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: March 20, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)