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Completed

NCT Number: NCT03551977

The Norwegian "iCanCope With Pain" App

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.

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Key information

Conditions

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

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erik Grasaas

Kristiansand, 4633, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
  • 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.

Treatment and study plan

iCanCope with Pain

Behavioral

The participants are free to use the Norwegian iCanCope with Pain app as much as they want during the 8 week intervention period. The only support available is technical support.

iCanCope with Pain control

Behavioral

The participants are free to use the Norwegian iCanCope with Pain control app as much as they want during the 8 week intervention period. The only support available is technical support.

Primary outcomes

  1. Attrition rate

    Time frame: Baseline and 8-weeks

    Change in participants completed the post-questionnaire divided by the number of participants at baseline.

  2. App engagement

    Time frame: Baseline to 8 weeks.

    Completion of daily symptom check-ins was used as a proxy for app engagement.

Secondary outcomes

  1. Physical activity

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the International Physical Activity Questionnaire (IPAQ). Higher values at post-intervention represent a better outcome.

  2. Coping

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the General Self-Efficacy Questionnaire Short Version (GSEQ). Higher values at post-intervention represent a better outcome.

  3. Social participation

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of school absence (General Information Questionnaire). Lower values at post-intervention represent a better outcome.

  4. Over-The-Counter (OTC) analgesics

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of OTC analgesics consumption (General Information Questionnaire). Lower values at post-intervention represent a better outcome.

  5. Perceived social support from friends

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the Perceived Social Support from friends Questionnaire (PSS). Higher values at post-intervention represent a better outcome.

  6. Pain self-efficacy questionnaire

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the Pain Self-Efficacy Questionnaire (PSEQ). Higher values at post-intervention represent a better outcome.

  7. Anxiety and depression

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the Hospital Anxiety and Depression Scale Questionnaire (HADS). Lower values at post-intervention represent a better outcome.

  8. Global impression of change

    Time frame: After 8 weeks (post-intervention)

    Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome.

  9. Health-related quality of life (HRQOL)

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the Kidscreen 52 Questionnaire. Higher values at post-intervention represent a better outcome.

  10. Pain experience

    Time frame: Baseline and 8 weeks (post-intervention)

    Change in total score of the Lubeck Pain Questionnaire (LPQ). Lower values at post-intervention represent a better outcome.

Sponsors and collaborators

Lead sponsor

University of Agder

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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