Chronic PainHOPENCT02944786
Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program
A study testing HOPE-model in people with Chronic Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which includes patient education, person-centered health dialogues and pain/stress management), which is an adolescent-centered school health prevention program when adolescents have chronic pain. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- HOPE-model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Aug 2019
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All students who fulfill the criteria of chronic pain that is mediated by stress
Who cannot join
- Students who cannot speak Swedish or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which includes patient education, person-centered health dialogues and pain/stress management), which is an adolescent-centered school health prevention program when adolescents have chronic pain. This is an intervention that has the hypothesis to support students to manage their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated health, quality of sleep, pain intensity and school attendance. The project aims to evaluate the intervention through qualitative and quantitative data collection by students and school nurses. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection. The results of this project can be of great importance in the early detection of students with chronic pain and promote their confidence in their own ability to manage their symptoms.
Read the detailed description
School nurses who perform the person-centered health dialogues with the students will have an education, which includes a various of lectures about person-centered health dialogues, stress/pain management and school nurses (over-)generalizations of gender. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection.
All students at the participating schools who fulfill the criteria of chronic pain that is mediated by stress, will be invited to participate in the intervention. The participants will be randomized to either group A or group B.
Participants will once report frequency, duration and intensity of pain and they also fill in the questionnaire Center for Epidemiologic Studies Depression Scale for Children.
In the first period of data collection, the group A will get four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). Group B will be a control group.
All participating school nurses and students will be interviewed about their experiences of the intervention.
In the second period of data collection it will be the other way around, i.e., group B will will get four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). Group A will be the control group.
All participating school nurses and students will once again be interviewed about their experiences of the intervention.
The primary outcome in the intervention is self-efficacy and this outcome will be measured before and after the intervention in both group A and group B. Secondary outcomes are self-rated health, quality of sleep, pain intensity, and school attendance and these outcomes will also be measured before and after the intervention in both group A and group B.
- Conditions
- Chronic Pain
- Being tested
- HOPE-model
- Keywords
- Chronic pain, Adolescents, School nurse
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE-modelBehavioural
There are four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain).
| Study group | Role | What they receive |
|---|---|---|
| HOPE-model | Experimental | Four person-centred health dialogue sessions that include pain/stress management and education about stress and pain. Receives: Behavioral: HOPE-model |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Efficacy for Daily Activities (SEDA) score
Measurement of changes in SEDA from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Measured: baseline and 5 weeks after baseline
Long term change in Self-Efficacy for Daily Activities (SEDA) score
A follow-up measurement of SEDA that will be done at time point 3, i.e. 6 months after baseline.
Measured: baseline and 6 months after baseline
Secondary outcomes (8)
Change in Minimal Insomnia Symptom Scale (MISS) score
Measurement of changes in MISS from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Measured: baseline and 5 weeks after baseline
Long term Change in Minimal Insomnia Symptom Scale (MISS) score
A follow-up measurement of MISS that will be done at time point 3, i.e. 6 months after baseline.
Measured: baseline and 6 months after baseline
Change in Numeric Rating Scale (NRS) for school attendance
Measurement of changes in NRS school attendance from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Measured: baseline and 5 weeks after baseline
Long term in Numeric Rating Scale (NRS) of school attendance
A follow-up measurement of NRS school attendance that will be done at time point 3, i.e. 6 months after baseline.
Measured: baseline and 6 months after baseline
Change of Numeric Rating Scale (NRS) score of pain intensity
Measurement of changes in NRS pain intensity from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Measured: baseline and 5 weeks after baseline
Long term change in Numeric Rating Scale (NRS) score pain intensity
A follow-up measurement of NRS pain intensity that will be done at time point 3, i.e. 6 months after baseline.
Measured: baseline and 6 months after baseline
Change in Self-Rated Health (SRH) score
Measurement of changes in SRH from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Measured: baseline and 5 weeks after baseline
Long term change in Self-Rated Health (SRH) score
A follow-up measurement of SRH that will be done at time point 3, i.e. 6 months after baseline.
Measured: baseline and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Nilsson, PhD, Principal investigator, Institute of Health and Care Sciences, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944786
- Sponsor's protocol ID
- 205205215
- Acronym
- HOPE
- Status last verified
- Feb 2020
- First submitted
- 17 Oct 2016
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alfven G, Nilsson S. Validity and reliability of a new short verbal rating scale for stress for use in clinical practice. Acta Paediatr. 2014 Apr;103(4):e173-5. doi: 10.1111/apa.12558. Epub 2014 Feb 18. No abstract available.
PubMed 24533818Barkmann C, Erhart M, Schulte-Markwort M; BELLA Study Group. The German version of the Centre for Epidemiological Studies Depression Scale for Children: psychometric evaluation in a population-based survey of 7 to 17 years old children and adolescents--results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:116-24. doi: 10.1007/s00787-008-1013-0.
PubMed 19132311Broman JE, Smedje H, Mallon L, Hetta J. The Minimal Insomnia Symptom Scale (MISS): a brief measure of sleeping difficulties. Ups J Med Sci. 2008;113(2):131-42. doi: 10.3109/2000-1967-221.
PubMed 18509808Castarlenas E, Sanchez-Rodriguez E, Vega Rde L, Roset R, Miro J. Agreement between verbal and electronic versions of the numerical rating scale (NRS-11) when used to assess pain intensity in adolescents. Clin J Pain. 2015 Mar;31(3):229-34. doi: 10.1097/AJP.0000000000000104.
PubMed 24699160Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Duberg A, Hagberg L, Sunvisson H, Moller M. Influencing self-rated health among adolescent girls with dance intervention: a randomized controlled trial. JAMA Pediatr. 2013 Jan;167(1):27-31. doi: 10.1001/jamapediatrics.2013.421.
PubMed 23403597Holm S, Ljungman G, Asenlof P, Linton SJ, Soderlund A. Treating youth in pain: Comparing tailored behavioural medicine treatment provided by physical therapists in primary care with physical exercises. Eur J Pain. 2016 Apr;20(4):626-38. doi: 10.1002/ejp.780. Epub 2015 Sep 24.
PubMed 26399225
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Help Overcoming Pain Early - an Adolescent-centered School Health Prevention Program When Adolescents Have Chronic Pain
- ClinicalTrials.gov ID
- NCT02944786
- Acronym / sponsor ID
- HOPE / 205205215
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Adolescents, School nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the project is to evaluate the Help Overcoming Pain Early model (which includes patient education, person-centered health dialogues and pain/stress management), which is an adolescent-centered school health prevention program when adolescents have chronic pain. This is an intervention that has the hypothesis to support students to manage their chronic pain. The primary outcome is self-efficacy. Secondary outcomes are self-rated health, quality of sleep, pain intensity and school attendance. The project aims to evaluate the intervention through qualitative and quantitative data collection by students and school nurses. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection. The results of this project can be of great importance in the early detection of students with chronic pain and promote their confidence in their own ability to manage their symptoms.
Detailed description
School nurses who perform the person-centered health dialogues with the students will have an education, which includes a various of lectures about person-centered health dialogues, stress/pain management and school nurses (over-)generalizations of gender. The project has a hybrid design, which means that outcomes of the intervention and the evaluation of the implementation are taking place in the same data collection.
All students at the participating schools who fulfill the criteria of chronic pain that is mediated by stress, will be invited to participate in the intervention. The participants will be randomized to either group A or group B.
Participants will once report frequency, duration and intensity of pain and they also fill in the questionnaire Center for Epidemiologic Studies Depression Scale for Children.
In the first period of data collection, the group A will get four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). Group B will be a control group.
All participating school nurses and students will be interviewed about their experiences of the intervention.
In the second period of data collection it will be the other way around, i.e., group B will will get four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). Group A will be the control group.
All participating school nurses and students will once again be interviewed about their experiences of the intervention.
The primary outcome in the intervention is self-efficacy and this outcome will be measured before and after the intervention in both group A and group B. Secondary outcomes are self-rated health, quality of sleep, pain intensity, and school attendance and these outcomes will also be measured before and after the intervention in both group A and group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE-model | Experimental | Behavioral: HOPE-modelFour person-centred health dialogue sessions that include pain/stress management and education about stress and pain. |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All students who fulfill the criteria of chronic pain that is mediated by stress
Key exclusion criteria (1 listed)
- Students who cannot speak Swedish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOPE-modelThere are four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain). | Behavioural | HOPE-model |
Primary outcome
Change in Self-Efficacy for Daily Activities (SEDA) score
Time frame: baseline and 5 weeks after baseline
Measurement of changes in SEDA from baseline to timepoint 2 that is directly after the intervention period, i.e. week 5 after baseline.
Long term change in Self-Efficacy for Daily Activities (SEDA) score
Time frame: baseline and 6 months after baseline
A follow-up measurement of SEDA that will be done at time point 3, i.e. 6 months after baseline.
8 secondary outcomes
Change in Minimal Insomnia Symptom Scale (MISS) score
Time frame: baseline and 5 weeks after baseline
Long term Change in Minimal Insomnia Symptom Scale (MISS) score
Time frame: baseline and 6 months after baseline
Change in Numeric Rating Scale (NRS) for school attendance
Time frame: baseline and 5 weeks after baseline
Long term in Numeric Rating Scale (NRS) of school attendance
Time frame: baseline and 6 months after baseline
Change of Numeric Rating Scale (NRS) score of pain intensity
Time frame: baseline and 5 weeks after baseline
Long term change in Numeric Rating Scale (NRS) score pain intensity
Time frame: baseline and 6 months after baseline
Change in Self-Rated Health (SRH) score
Time frame: baseline and 5 weeks after baseline
Long term change in Self-Rated Health (SRH) score
Time frame: baseline and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Results publication: PubMed 24533818Alfven G, Nilsson S. Validity and reliability of a new short verbal rating scale for stress for use in clinical practice. Acta Paediatr. 2014 Apr;103(4):e173-5. doi: 10.1111/apa.12558. Epub 2014 Feb 18. No abstract available.
- Results publication: PubMed 19132311Barkmann C, Erhart M, Schulte-Markwort M; BELLA Study Group. The German version of the Centre for Epidemiological Studies Depression Scale for Children: psychometric evaluation in a population-based survey of 7 to 17 years old children and adolescents--results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:116-24. doi: 10.1007/s00787-008-1013-0.
- Results publication: PubMed 18509808Broman JE, Smedje H, Mallon L, Hetta J. The Minimal Insomnia Symptom Scale (MISS): a brief measure of sleeping difficulties. Ups J Med Sci. 2008;113(2):131-42. doi: 10.3109/2000-1967-221.
- Results publication: PubMed 24699160Castarlenas E, Sanchez-Rodriguez E, Vega Rde L, Roset R, Miro J. Agreement between verbal and electronic versions of the numerical rating scale (NRS-11) when used to assess pain intensity in adolescents. Clin J Pain. 2015 Mar;31(3):229-34. doi: 10.1097/AJP.0000000000000104.
- Results publication: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Results publication: PubMed 23403597Duberg A, Hagberg L, Sunvisson H, Moller M. Influencing self-rated health among adolescent girls with dance intervention: a randomized controlled trial. JAMA Pediatr. 2013 Jan;167(1):27-31. doi: 10.1001/jamapediatrics.2013.421.
- Results publication: PubMed 26399225Holm S, Ljungman G, Asenlof P, Linton SJ, Soderlund A. Treating youth in pain: Comparing tailored behavioural medicine treatment provided by physical therapists in primary care with physical exercises. Eur J Pain. 2016 Apr;20(4):626-38. doi: 10.1002/ejp.780. Epub 2015 Sep 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Nilsson, PhD principal investigator
Institute of Health and Care Sciences, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE-model in people with Chronic Pain, run by Göteborg University at 1 site in Sweden.
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 1 inclusion and 1 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 6 Feb 2020. 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 Sweden. 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?
Change in Self-Efficacy for Daily Activities (SEDA) score (time frame: baseline and 5 weeks after baseline). 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 NCT02944786, which also lists 7 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 6 Feb 2020.