- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551977
The Norwegian "iCanCope With Pain" App
Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kristiansand, Norway, 4633
- Erik Grasaas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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
|
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.
|
Active Comparator: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attrition rate
Time Frame: Baseline and 8-weeks
|
Change in participants completed the post-questionnaire divided by the number of participants at baseline.
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Baseline and 8-weeks
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App engagement
Time Frame: Baseline to 8 weeks.
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Completion of daily symptom check-ins was used as a proxy for app engagement.
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Baseline to 8 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 8 weeks (post-intervention)
|
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.
|
Baseline and 8 weeks (post-intervention)
|
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.
|
Baseline and 8 weeks (post-intervention)
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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.
|
Baseline and 8 weeks (post-intervention)
|
Perceived social support from friends
Time Frame: Baseline and 8 weeks (post-intervention)
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Change in total score of the Perceived Social Support from friends Questionnaire (PSS).
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Pain self-efficacy questionnaire
Time Frame: Baseline and 8 weeks (post-intervention)
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Change in total score of the Pain Self-Efficacy Questionnaire (PSEQ).
Higher values at post-intervention represent a better outcome.
|
Baseline and 8 weeks (post-intervention)
|
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.
|
Baseline and 8 weeks (post-intervention)
|
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.
|
After 8 weeks (post-intervention)
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Health-related quality of life (HRQOL)
Time Frame: Baseline and 8 weeks (post-intervention)
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Change in total score of the Kidscreen 52 Questionnaire.
Higher values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Pain experience
Time Frame: Baseline and 8 weeks (post-intervention)
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Change in total score of the Lubeck Pain Questionnaire (LPQ).
Lower values at post-intervention represent a better outcome.
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Baseline and 8 weeks (post-intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristin Haraldstad, PhD, UiA
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1310 63221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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