Chronic PainPhase 2NCT01316471
Internet Intervention for Adolescents With Chronic Pain
A Phase 2 study testing Online Behavioral Intervention and Education: Online Patient Education in people with Chronic Pain and Abdominal Pain, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Chronic Pain, Abdominal Pain, Headache
- What is being tested?
- Online Behavioral Intervention and Education: Online Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2015
- Phase
- Phase 2
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Literate in English
- Age 11-17 years
- Pain present for at least 3 months duration
- Pain occurs at least 1 time per week and interferes with daily functioning
- Pain is not related to a chronic disease
- Receiving evaluation or treatment in a pediatric pain clinic
- Has access to a computer, the Internet, and a phone
Who cannot join
- A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
- Non-English speaking
- More than 4 sessions of CBT for pain management in the 6 months prior to the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain
The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.
Read the detailed description
An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.
- Conditions
- Chronic Pain, Abdominal Pain, Headache
- Being tested
- Online Behavioral Intervention, Education: Online Patient Education
- Keywords
- Chronic Pain, Abdominal Pain, Headache, Adolescents, Internet Interventions, Behavioral Interventions
- Medical subject headings
- Chronic Pain, Abdominal Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral InterventionBehavioural
Also called Internet Intervention
The online behavioral intervention is travel-themed and participants visit 8 destinations (1 per week) designed to take 30 min each to complete. The destinations serve as an online analog for the weekly sessions used when delivering behavioral interventions face-to-face. The 8 child destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) relaxation and distraction skills, 4) school, 5) cognitive skills, 6) sleep hygiene and lifestyle, 7) staying active, and 8) relapse prevention. The eight parent destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I, 4) operant strategies II, 5) modeling, 6) sleep hygiene and lifestyle, 7) communication, and 8) relapse prevention.
Education: Online Patient EducationOther
Also called Online Attention Control
The purpose of the online patient education group is to control for time, attention, and computer usage. Children and parents will be provided with access to a modified version of the study website that will provide links to information from publicly available educational websites about pediatric chronic pain management. Children and parents will log onto the web program weekly at the same interval as the Online Behavioral Intervention group. Children and parents will be asked to view 3 links each week and then report a few details pertaining to the content of what they viewed.
| Study group | Role | What they receive |
|---|---|---|
| Online Behavioral Intervention | Experimental | In addition to standard medical care, children and parents in the online behavioral intervention will receive access to the full web-based program including education about chronic pain, training in behavioral and cognitive coping skills, instruction in increasing activity participation, and education about pain behaviors and parental operant strategies using an engaging, interactive format on the Internet. Receives: Behavioral: Online Behavioral Intervention |
| Online Patient Education | Active comparator | The Online Patient Education group will serve as an attention control condition. In addition to standard medical care, children and parents will be provided with access to a modified version of the study website that will provide information from publicly available educational websites about pediatric chronic pain management. Receives: Other: Education: Online Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity limitations
Child report of activity limitations will be assessed using the prospective version of the Child Activity Limitations Interview (Palermo, Witherspoon, Valenzuela, \& Drotar, 2004), which includes 8 activities that children identify as important in their day-to-day lives that are impacted by pain. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Children will provide ratings daily for 7 days on their online diaries at each assessment period. Mean activity limitations across the reporting period is used in analyses.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Pain intensity
Children will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS) with anchors of 0= no pain to 10= worst pain (McGrath et al., 2008). Mean average intensity of the pain reported will serve as primary pain measure.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Secondary outcomes (6)
Depression and pain-specific anxiety
Children will complete the Bath Adolescent Pain Questionnaire (BAPQ), a 61-item scale that will be used to measure pain-specific emotional functioning (Eccleston et al., 2005). The BAPQ was developed specifically for children with chronic pain and has demonstrated adequate reliability and validity (Eccleston et al., 2008). For the purpose of this study, the subscales of depression and pain-specific anxiety will be used in analyses.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Treatment Satisfaction
Children and parents will complete this questionnaire, which includes items that address satisfaction with the therapeutic process during the course of treatment and satisfaction with the outcome of therapy. Items are rated on a 5-point scale from 1 = strongly disagree to 5 = strongly agree.
Measured: Immediately Post-Treatment, 6-month follow-up, 12-month follow-up
Parental Response to Pain Behavior
Children and their parents will complete the Adult Responses to Children's Symptoms (ARCS), a 29-item measure assessing parental responses to child pain behavior (Walker, Levy, \& Whitehead, 2006). Respondents rate on a five-point Likert scale the frequency with which parents engage in specific behaviors in response to their child's pain.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Sleep Quality
Children's perception of sleep quality will be measured by the Adolescent Sleep Wake Scale (LeBourgeois et al., 2005), a 28-item self-report scale that assesses five behavioral dimensions of teens' sleep: going to bed, falling asleep, maintaining sleep, reinitiating sleep, and returning to wakefulness. Subscale scores range from 1 to 6, with higher scores indicating better sleep quality.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Health service Use
Parents will complete the Client Service Receipt Inventory-Pain version (Sleed et al., 2005), a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used, number of lost parental work days, and number of out-of-pocket expenses.
Measured: pre-treatment, 12-month follow-up
Miscarried Helping
Parents and adolescents will complete the Helping for Health Inventory (Harris et al., 2008), a 15-item scale that measures miscarried helping or negative social support. Respondents rate on a 5-point scale the frequency with which parents engage in certain behaviors or feel certain ways pertaining to their child's health.
Measured: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Seattle Children's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
- Investigators
- Tonya M. Palermo, Ph.D., Principal investigator, University of Washington Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316471
- Sponsor's protocol ID
- R01HD062538-01A1
- Status last verified
- Oct 2018
- First submitted
- 11 Mar 2011
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palermo TM, Law EF, Zhou C, Holley AL, Logan D, Tai G. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate? Pain. 2015 Apr;156(4):626-634. doi: 10.1097/01.j.pain.0000460355.17246.6c.
PubMed 25775441Law EF, Groenewald CB, Zhou C, Palermo TM. Effect on Health Care Costs for Adolescents Receiving Adjunctive Internet-Delivered Cognitive-Behavioral Therapy: Results of a Randomized Controlled Trial. J Pain. 2018 Aug;19(8):910-919. doi: 10.1016/j.jpain.2018.03.004. Epub 2018 Mar 22.
PubMed 29578090
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain
- ClinicalTrials.gov ID
- NCT01316471
- Acronym / sponsor ID
- R01HD062538-01A1
- Conditions
- Chronic Pain, Abdominal Pain, Headache
- Keywords
- Chronic Pain, Abdominal Pain, Headache, Adolescents, Internet Interventions, Behavioral Interventions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Mar 2011 (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 purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.
Detailed description
An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Behavioral Intervention | Experimental | Behavioral: Online Behavioral InterventionIn addition to standard medical care, children and parents in the online behavioral intervention will receive access to the full web-based program including education about chronic pain, training in behavioral and cognitive coping skills, instruction in increasing activity participation, and education about pain behaviors and parental operant strategies using an engaging, interactive format on the Internet. |
| Online Patient Education | Active comparator | Other: Education: Online Patient EducationThe Online Patient Education group will serve as an attention control condition. In addition to standard medical care, children and parents will be provided with access to a modified version of the study website that will provide information from publicly available educational websites about pediatric chronic pain management. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Literate in English
- Age 11-17 years
- Pain present for at least 3 months duration
- Pain occurs at least 1 time per week and interferes with daily functioning
- Pain is not related to a chronic disease
Key exclusion criteria (3 listed)
- A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
- Non-English speaking
- More than 4 sessions of CBT for pain management in the 6 months prior to the time of screening.
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 |
|---|---|---|
| Online Behavioral InterventionAlso: Internet InterventionThe online behavioral intervention is travel-themed and participants visit 8 destinations (1 per week) designed to take 30 min each to complete. The destinations serve as an online analog for the weekly sessions used when delivering behavioral interventions face-to-face. The 8 child destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) relaxation and distraction skills, 4) school, 5) cognitive skills, 6) sleep hygiene and lifestyle, 7) staying active, and 8) relapse prevention. The eight parent destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I, 4) operant strategies II, 5) modeling, 6) sleep hygiene and lifestyle, 7) communication, and 8) relapse prevention. | Behavioural | Online Behavioral Intervention |
| Education: Online Patient EducationAlso: Online Attention ControlThe purpose of the online patient education group is to control for time, attention, and computer usage. Children and parents will be provided with access to a modified version of the study website that will provide links to information from publicly available educational websites about pediatric chronic pain management. Children and parents will log onto the web program weekly at the same interval as the Online Behavioral Intervention group. Children and parents will be asked to view 3 links each week and then report a few details pertaining to the content of what they viewed. | Other | Online Patient Education |
Primary outcome
Activity limitations
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Child report of activity limitations will be assessed using the prospective version of the Child Activity Limitations Interview (Palermo, Witherspoon, Valenzuela, \& Drotar, 2004), which includes 8 activities that children identify as important in their day-to-day lives that are impacted by pain. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Children will provide ratings daily for 7 days on their online diaries at each assessment period. Mean activity limitations across the reporting period is used in analyses.
Pain intensity
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Children will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS) with anchors of 0= no pain to 10= worst pain (McGrath et al., 2008). Mean average intensity of the pain reported will serve as primary pain measure.
6 secondary outcomes
Depression and pain-specific anxiety
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Treatment Satisfaction
Time frame: Immediately Post-Treatment, 6-month follow-up, 12-month follow-up
Parental Response to Pain Behavior
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Sleep Quality
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
Health service Use
Time frame: pre-treatment, 12-month follow-up
Miscarried Helping
Time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up
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 3 Oct 2018.
- Results publication: PubMed 25775441Palermo TM, Law EF, Zhou C, Holley AL, Logan D, Tai G. Trajectories of change during a randomized controlled trial of internet-delivered psychological treatment for adolescent chronic pain: how does change in pain and function relate? Pain. 2015 Apr;156(4):626-634. doi: 10.1097/01.j.pain.0000460355.17246.6c.
- Derived from this study: PubMed 29578090Law EF, Groenewald CB, Zhou C, Palermo TM. Effect on Health Care Costs for Adolescents Receiving Adjunctive Internet-Delivered Cognitive-Behavioral Therapy: Results of a Randomized Controlled Trial. J Pain. 2018 Aug;19(8):910-919. doi: 10.1016/j.jpain.2018.03.004. Epub 2018 Mar 22.
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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.
Tonya M. Palermo, Ph.D. principal investigator
University of Washington Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Online Behavioral Intervention and Education: Online Patient Education in people with Chronic Pain and Abdominal Pain, run by Seattle Children's Hospital at 1 site in United States.
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 7 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 3 Oct 2018. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Activity limitations (time frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up). 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 NCT01316471, 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 3 Oct 2018.