Gastrointestinal Disorders, FunctionalNCT02327377
Web-based Management of Pediatric Functional Abdominal Pain
A study testing Online Cognitive Behavior Therapy and Online Education in people with Gastrointestinal Disorders, Functional, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Gastrointestinal Disorders, Functional
- What is being tested?
- Online Cognitive Behavior Therapy and Online Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 28 Jan 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Referred for medical evaluation of abdominal pain of more than 3 months duration
- No prior diagnosis of organic disease that explains the pain
- Access to a computer and the internet
Who cannot join
- Presence of major medical condition (e.g., diabetes)
- Does not speak English
- Has a disability that precludes participation
- Does not have a participating parent/guardian
- Found to have significant organic disease (e.g., ulcerative colitis) in the medical evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
About this study
Official title: Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
Read the detailed description
The goal of our research is to identify individual differences in pediatric functional abdominal pain (FAP) that predict differential health outcomes and can be used to develop tailored approaches to the evaluation and treatment of FAP. Effective treatment of FAP is a critical public health issue because it is among the most common pain problems during childhood and prospectively predicts risk for chronic pain, disability, and frequent health service utilization (HSU) in early adulthood. Although cognitive behavior therapy (CBT) delivered by highly trained professionals in face-to-face sessions has been found to reduce pain in some FAP patients, such intensive resources are not generally available to the large population of FAP patients. This study will evaluate an alternative, more efficient approach to treating pediatric FAP. The study builds on and integrates recent work by two leading investigators in pediatric pain. First, in a prospective natural history study of pediatric onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of the initial FAP evaluation in childhood. These profiles predicted chronic pain and related health outcomes at follow-up (FU) nearly a decade later. Patients with the High Pain Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited pro-nociceptive central pain modulation in laboratory pain testing at FU. The heterogeneity of the FAP pain profile groups suggests that they may differ in treatment needs and in the extent to which they benefit significantly more from adjunctive behavioral treatment as compared to usual care alone. Second, Co-Investigator Palermo developed and tested a CBT intervention delivered online (Web-based Management of Adolescent Pain; Web-MAP) which is an efficient, easily disseminated treatment that significantly reduced pain and disability in youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual care, wait-list control group. This study merges these lines of research into an innovative study that will, for the first time: (Aim 1) evaluate the efficacy of WebMAP administered to FAP patients and their parents; (Aim 2) evaluate baseline moderators of treatment response, including our previously validated FAP pain profiles, pro-nociceptive central pain modulation, and parent characteristics (protectiveness, modeling pain behavior, catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the effect of WebMAP on health outcomes. Pediatric patients (n = 300) ages 11-17 years will be randomized to either WebMAP or a Usual Care (UC) control group following their initial subspecialty FAP evaluation. Assessments will be at baseline, mid- and post-treatment, and at 6- and 12-months post baseline. Study results will produce knowledge that can be used to more efficiently target interventions to FAP patients according to their individual needs and thereby extend evidence-based care to more patients and ultimately reduce overall costs of care.
- Conditions
- Gastrointestinal Disorders, Functional
- Being tested
- Online Cognitive Behavior Therapy, Online Education
- Keywords
- Irritable bowel syndrome, Intervention studies, Visceral pain, Chronic pain, Abdominal pain, Dyspepsia, Nausea, Nociception, Parents, Coping behavior, Anxiety, Depression, Catastrophization, Reinforcement (psychology), Self efficacy, Health services overutilization, Questionnaires, Self report, Health surveys, Prospective studies
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome, Visceral Pain, Chronic Pain, Abdominal Pain, Dyspepsia, Nausea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive Behavior TherapyBehavioural
Online EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Online Cognitive Behavior Therapy | Experimental | Online cognitive behavior therapy for coping with pain Receives: Behavioral: Online Cognitive Behavior Therapy |
| Online Education | Active comparator | Educational information about pain Receives: Behavioral: Online Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline somatic symptoms
Change from baseline somatic symptoms as measured by the Children's Somatization Inventory
Measured: 2 months after baseline
Change from baseline abdominal pain
Change from baseline abdominal pain as measured by Abdominal Pain Index
Measured: long-term follow-up (6 and 12 months after baseline)
Secondary outcomes (1)
Change from baseline activity limitations
Change from baseline activity limitations as measured by the Patient Reported Outcomes Measurement Information System Pain Interference Scale
Measured: 2 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 posted30 Dec 2014 (estimated)
- Study startApr 2014
- Primary completion16 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Disorders, FunctionalStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Lynn Walker, Vanderbilt University Medical Center
- Investigators
- Lynn Walker, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327377
- Sponsor's protocol ID
- 140559
- Status last verified
- Mar 2019
- First submitted
- 10 Dec 2014
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Walker LS, Stone AL, Han GT, Garber J, Bruehl S, Smith CA, Anderson J, Palermo TM. Internet-delivered cognitive behavioral therapy for youth with functional abdominal pain: a randomized clinical trial testing differential efficacy by patient subgroup. Pain. 2021 Dec 1;162(12):2945-2955. doi: 10.1097/j.pain.0000000000002288.
PubMed 34793406
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT02327377
- Acronym / sponsor ID
- 140559
- Conditions
- Gastrointestinal Disorders, Functional
- Keywords
- Irritable bowel syndrome, Intervention studies, Visceral pain, Chronic pain, Abdominal pain, Dyspepsia, Nausea, Nociception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- Apr 2014
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 30 Dec 2014 (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.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
Detailed description
The goal of our research is to identify individual differences in pediatric functional abdominal pain (FAP) that predict differential health outcomes and can be used to develop tailored approaches to the evaluation and treatment of FAP. Effective treatment of FAP is a critical public health issue because it is among the most common pain problems during childhood and prospectively predicts risk for chronic pain, disability, and frequent health service utilization (HSU) in early adulthood. Although cognitive behavior therapy (CBT) delivered by highly trained professionals in face-to-face sessions has been found to reduce pain in some FAP patients, such intensive resources are not generally available to the large population of FAP patients. This study will evaluate an alternative, more efficient approach to treating pediatric FAP. The study builds on and integrates recent work by two leading investigators in pediatric pain. First, in a prospective natural history study of pediatric onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of the initial FAP evaluation in childhood. These profiles predicted chronic pain and related health outcomes at follow-up (FU) nearly a decade later. Patients with the High Pain Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited pro-nociceptive central pain modulation in laboratory pain testing at FU. The heterogeneity of the FAP pain profile groups suggests that they may differ in treatment needs and in the extent to which they benefit significantly more from adjunctive behavioral treatment as compared to usual care alone. Second, Co-Investigator Palermo developed and tested a CBT intervention delivered online (Web-based Management of Adolescent Pain; Web-MAP) which is an efficient, easily disseminated treatment that significantly reduced pain and disability in youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual care, wait-list control group. This study merges these lines of research into an innovative study that will, for the first time: (Aim 1) evaluate the efficacy of WebMAP administered to FAP patients and their parents; (Aim 2) evaluate baseline moderators of treatment response, including our previously validated FAP pain profiles, pro-nociceptive central pain modulation, and parent characteristics (protectiveness, modeling pain behavior, catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the effect of WebMAP on health outcomes. Pediatric patients (n = 300) ages 11-17 years will be randomized to either WebMAP or a Usual Care (UC) control group following their initial subspecialty FAP evaluation. Assessments will be at baseline, mid- and post-treatment, and at 6- and 12-months post baseline. Study results will produce knowledge that can be used to more efficiently target interventions to FAP patients according to their individual needs and thereby extend evidence-based care to more patients and ultimately reduce overall costs of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Cognitive Behavior Therapy | Experimental | Behavioral: Online Cognitive Behavior TherapyOnline cognitive behavior therapy for coping with pain |
| Online Education | Active comparator | Behavioral: Online EducationEducational information about pain |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Referred for medical evaluation of abdominal pain of more than 3 months duration
- No prior diagnosis of organic disease that explains the pain
- Access to a computer and the internet
Key exclusion criteria (5 listed)
- Presence of major medical condition (e.g., diabetes)
- Does not speak English
- Has a disability that precludes participation
- Does not have a participating parent/guardian
- Found to have significant organic disease (e.g., ulcerative colitis) in the medical evaluation
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 Cognitive Behavior Therapy | Behavioural | Online Cognitive Behavior Therapy |
| Online Education | Behavioural | Online Education |
Primary outcome
Change from baseline somatic symptoms
Time frame: 2 months after baseline
Change from baseline somatic symptoms as measured by the Children's Somatization Inventory
Change from baseline abdominal pain
Time frame: long-term follow-up (6 and 12 months after baseline)
Change from baseline abdominal pain as measured by Abdominal Pain Index
1 secondary outcome
Change from baseline activity limitations
Time frame: 2 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 28 Mar 2019.
- Derived from this study: PubMed 34793406Walker LS, Stone AL, Han GT, Garber J, Bruehl S, Smith CA, Anderson J, Palermo TM. Internet-delivered cognitive behavioral therapy for youth with functional abdominal pain: a randomized clinical trial testing differential efficacy by patient subgroup. Pain. 2021 Dec 1;162(12):2945-2955. doi: 10.1097/j.pain.0000000000002288.
- Individual participant dataSharing planned: Undecided
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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.
Lynn Walker, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Behavior Therapy and Online Education in people with Gastrointestinal Disorders, Functional, run by Vanderbilt University Medical Center 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 3 inclusion and 5 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 28 Mar 2019. 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.
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 from baseline somatic symptoms (time frame: 2 months 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 NCT02327377, which also lists 1 linked publication.
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 28 Mar 2019.