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PainNCT03551977

The Norwegian "iCanCope With Pain" App

A study testing iCanCope with Pain in people with Pain, run by University of Agder at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 19 years
Conditions the study is for
Pain
What is being tested?
iCanCope with Pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteNorway
Study dates
28 Nov 2017to 15 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Erik Grasaas

    Kristiansand, 4633

Other trials in Norway

About this study

Official title: 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.

Read more

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.

Conditions
Pain
Being tested
iCanCope with Pain, iCanCope with Pain control
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCanCope with PainBehavioural

    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 controlBehavioural

    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.

Study groups in NCT03551977
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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
Receives: Behavioral: iCanCope with Pain
Control groupActive comparatorThe 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.
Receives: Behavioral: iCanCope with Pain control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attrition rate

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

    Measured: Baseline and 8-weeks

  2. App engagement

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

    Measured: Baseline to 8 weeks.

Secondary outcomes (10)

  1. Physical activity

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

    Measured: Baseline and 8 weeks (post-intervention)

  2. Coping

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

    Measured: Baseline and 8 weeks (post-intervention)

  3. Social participation

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

    Measured: Baseline and 8 weeks (post-intervention)

  4. Over-The-Counter (OTC) analgesics

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

    Measured: Baseline and 8 weeks (post-intervention)

  5. Perceived social support from friends

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

    Measured: Baseline and 8 weeks (post-intervention)

  6. Pain self-efficacy questionnaire

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

    Measured: Baseline and 8 weeks (post-intervention)

  7. Anxiety and depression

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

    Measured: Baseline and 8 weeks (post-intervention)

  8. Global impression of change

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

    Measured: After 8 weeks (post-intervention)

  9. Health-related quality of life (HRQOL)

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

    Measured: Baseline and 8 weeks (post-intervention)

  10. Pain experience

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

    Measured: Baseline and 8 weeks (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start28 Nov 2017
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single-centre, RCT study design with two arms, one control group (N=56) and one intervention group (N=56).
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551977
Sponsor's protocol ID
1310 63221
Status last verified
Nov 2022
First submitted
15 May 2018
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35897086

  • 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.

    PubMed 32000787

Questions about this trial

What is this clinical trial studying?

A study testing iCanCope with Pain in people with Pain, run by University of Agder at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attrition rate (time frame: Baseline and 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551977, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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