Clinical trial NCT03551977: The Norwegian "iCanCope With Pain" App
Official title: Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Agder
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2018-06-11
Enrollment: 112
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre, RCT study design with two arms, one control group (N=56) and one intervention group (N=56).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Attrition rate
timeFrame: Baseline and 8-weeks
measure: App engagement
timeFrame: Baseline to 8 weeks.
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Coping
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Social participation
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Over-The-Counter (OTC) analgesics
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Perceived social support from friends
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Pain self-efficacy questionnaire
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Anxiety and depression
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Global impression of change
timeFrame: After 8 weeks (post-intervention)
measure: Health-related quality of life (HRQOL)
timeFrame: Baseline and 8 weeks (post-intervention)
measure: Pain experience
timeFrame: Baseline and 8 weeks (post-intervention)
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Erik Grasaas
Study officials:
affiliation: UiA
name: Kristin Haraldstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grasaas E, Helseth S, Fegran L, Stinson J, Smastuen M, Lalloo C, Haraldstad K. App-based intervention among adolescents with persistent pain: a pilot feasibility randomized controlled trial. Pilot Feasibility Stud. 2022 Jul 27;8(1):158. doi: 10.1186/s40814-022-01113-0.
citation: Grasaas E, Helseth S, Fegran L, Stinson J, Smastuen M, Haraldstad K. Health-related quality of life in adolescents with persistent pain and the mediating role of self-efficacy: a cross-sectional study. Health Qual Life Outcomes. 2020 Jan 30;18(1):19. doi: 10.1186/s12955-020-1273-z.