The Norwegian "iCanCope With Pain" App

University of Agder

Status: Completed

Conditions: Pain

Treatments: Behavioral: iCanCope with Pain; Behavioral: iCanCope with Pain control

Study type: Interventional

Funder types: Other

Identifiers

NCT03551977

1310 63221

Details and patient eligibility

About

Background: Research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. Psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. The iCanCope with Pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the Canadian Institutes of Health Research and is based on identified health care needs and current best practices for pain self-management.

Objectives: The primary objectives are to describe the translation and cultural adaptation of the Norwegian version of the iCanCope with Pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain.

Study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. Recruited from high schools in Southern Norway.

Theoretical framework: Cognitive behavioral therapy (CBT) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. The theoretical framework of CBT is integrated in the iCanCope with Pain app in terms of five components. The intervention group will receive the app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education. The control group will receive the app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.

Methods: Both qualitative and quantitative data will be gathered for evaluating the Norwegian version of the iCanCope with Pain app. Usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (RCT). Outcomes will in the RCT be measured at baseline (mid-April) and after an 8 weeks intervention (mid-June).

The study is part of a PhD project.

Enrollment: 112 patients

Sex: All

Ages: 16 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 16-19-year-old adolescents
2. with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting
3. be able to read and understand Norwegian
4. have their own smartphone.

Exclusion criteria

1. Adolescents with cognitive disability or diseases, because of the risk of not correctly understanding the iCanCope with Pain program via self-report, goal setting and/or library reading.
2. Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
3. Adolescents with diagnoses from a pathological or medical origin (e.g hematology/oncology patients) will also be excluded because the program was not specifically designed for these pain groups.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive the iCanCope with Pain app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education

Treatment:

Behavioral: iCanCope with Pain

Control group

Active Comparator group

Description:

The control group will receive the iCanCope with Pain control app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.

Treatment:

Behavioral: iCanCope with Pain control