Functional Abdominal Pain SyndromeFAPDNCT06481072
Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders in Primary Care
A study testing Digital patient education and Digital patient education and iCBT in people with Functional Abdominal Pain Syndrome, run by Göteborg University at 1 site in Sweden.
Trial summary
The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abdominal Pain Syndrome
- What is being tested?
- Digital patient education and Digital patient education and iCBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eligible participants are children and young people aged 8-14.
- Diagnosed with functional abdominal pain disorders by their physician.
- Diagnosed at one of the participating primary care health centres.
Who cannot join
- Children and young people with scores above the clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS).
- Children who do not follow the mainstream Swedish National Curriculum due to learning disabilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Gothenburg University
Gothenburg
Sandra Weineland, PhD, +46 708735788, sandra.weineland@vgregion.se, sandra.weineland@psy.gu.se
Emma Ramsay Milford, DEdPsy, +46708276061, emma.ramsay.milford@vgregion.se
About this study
Official title: Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders Through a Collaborative Pathway Between Primary- and Specialist Pediatric Care: A Randomized Clinical Trial
The project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.
Read the detailed description
The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics (CPC, Swedish Barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (HC). As children with FAPD benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC, following which digital interventions with two levels, managed by CPC, will be provided. The aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about FAPD, and level 2 is a digitally delivered cognitive behavior therapy (CBT) based psychological intervention for FAPD. The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland (VGR).
- Conditions
- Functional Abdominal Pain Syndrome
- Being tested
- Digital patient education, Digital patient education and iCBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient educationOther
This educative intervention includes both medical and psychological explanations, as well as basic strategies to manage pediatric FAPD. The medical information spans the topics of pain, functional abdominal pain and general advice in terms of child health, and the psychological information is based on cognitive-behavioural and pain management theoretical approaches. The intervention consists of six short, animated films with a total run-time of approximately 30 minutes. The films each cover one of the following topics; Why and how do we feel pain? What is functional abdominal pain? How to help: general advice, Thoughts, feelings and behaviour, Goals and strategies. The films are accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform that is recognised by the care provider as meeting current safety criteria and standards.
Digital patient education and iCBTOther
This includes the educative intervention and a fully digital, four session version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), a CBT treatment program for FAPD. The treatment focuses on pain-management through the following core elements; The Pain-Gate Theory, breathing and relaxation strategies, calming statements, activity pacing, problem solving and behavior activation. This intervention is also accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform.
| Study group | Role | What they receive |
|---|---|---|
| Intervention level 1 - patient education treatment. | Experimental | Participants who are randomized to experimental condition arm 1 will be offered patient education for functional abdominal pain disorder (FAPD). Receives: Other: Digital patient education |
| Intervention level 2 - patient education and iCBT | Experimental | Participants who are randomized to experimental condition arm 2 will be offered patient education treatment and internet delivered cognitive behavior therapy (iCBT) treatment. Receives: Other: Digital patient education and iCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain related functional disability.
Functional disability is measured with the child report version of the Functional Disabilities Inventory (FDI). The FDI is a 15-item measure of difficulty in performing activities in the past several days, valid for youth with chronic pain, and is used in FAPD. Items are rated on a 5-point Likert scale, ranging from 0 to 4 ("No Trouble" to "Impossible") and summed to create a total score (range 0-60). Higher scores indicate greater disability.
Measured: Within a week after intervention completion, 6 months after completion and 12 months after completion
Change from baseline in pain intensity.
Level of pain intensity will be obtained using a Visual Analogue Scale (VAS) 0-10. Higher scores indicate greater pain intensity.
Measured: Within a week after intervention completion, 6 months after completion and 12 months after completion.
Change from baseline in gastro symptom related worry.
Child version of the Visceral Sensitivity Index (VSI-C) will be used to measure level of gastro-symptom related worry. The VSI-C is a 7-item rating scale, valid for children with functional abdominal pain disorders. Worry is rated 1-6 where higher scores indicate greater gastro-symptom related worry. Scores are summed to create a total score (range 0-42).
Measured: Within a week after intervention completion, 6 months after completion and 12 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal Pain SyndromeStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481072
- Sponsor's protocol ID
- Dnr 2023-05902-01
- Acronym
- FAPD
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Ethical and Legal Considerations: * Data will be anonymized per data protection laws to safeguard patient privacy. * Researchers must sign a data sharing agreement detailing data use, security measures, and confidentiality requirements. 2. Ethics Committee Approval: * Documentation of approval from a relevant ethics committee is required to ensure ethical soundness. 3. Scope and Responsibility: * Requesters must describe the intended data use and ensure data is not used for other purposes without consent. * Findings from data use must be shared with us before publication. 4. Security Measures: * Researchers must show that appropriate technical and organizational measures are in place for secure data handling and storage.
Publications
Cunningham NR, Nelson S, Jagpal A, Moorman E, Farrell M, Pentiuk S, Kashikar-Zuck S. Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):16-20. doi: 10.1097/MPG.0000000000001714.
PubMed 28906315Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.
PubMed 15680928Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.
PubMed 33130153Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
PubMed 16480823Lalouni M, Olen O, Bjureberg J, Bonnert M, Chalder T, Hedman-Lagerlof E, Reme SE, Serlachius E, Ljotsson B. Validation of child-adapted short scales for measuring gastrointestinal-specific avoidance and anxiety. Acta Paediatr. 2022 Aug;111(8):1621-1627. doi: 10.1111/apa.16403. Epub 2022 May 27.
PubMed 35545865
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Psychological Intervention for Pediatric Functional Abdominal Pain Disorders Through a Collaborative Pathway Between Primary- and Specialist Pediatric Care: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06481072
- Acronym / sponsor ID
- FAPD / Dnr 2023-05902-01
- Conditions
- Functional Abdominal Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2024 (actual)
- 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 project involves researching two psychological treatments for functional abdominal pain in children. The treatments will be offered to children as an early intervention, at primary care level. The study will aim to find out if the treatments are effective and which children the different treatments are effective for.
Detailed description
The research project involves evaluating the efficacy of a collaborative care pathway with a two-level stepped-care model for pediatric FAPD where specialist level community-based pediatric clinics (CPC, Swedish Barn- och ungdomsmedicinsk mottagning) provide consultation and intervention to primary care health centers (HC). As children with FAPD benefit from early intervention, a stepped-care model of delivery at primary care level via a collaborative pathway could potentially be a way to divert more resources to those who need it most. The model explores a collaboration whereby an initial diagnosis of FAPD will be made by a general practitioner at a participating HC, following which digital interventions with two levels, managed by CPC, will be provided. The aim of the study is to explore the effectiveness of the two levels in the stepped-care model, where level 1 involves digitally provided psychoeducation and enhanced information about FAPD, and level 2 is a digitally delivered cognitive behavior therapy (CBT) based psychological intervention for FAPD. The CBT intervention is a fully digital version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which has been developed into a Swedish language version through a project funded by the innovation fund in Region Vastragotaland (VGR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention level 1 - patient education treatment. | Experimental | Other: Digital patient educationParticipants who are randomized to experimental condition arm 1 will be offered patient education for functional abdominal pain disorder (FAPD). |
| Intervention level 2 - patient education and iCBT | Experimental | Other: Digital patient education and iCBTParticipants who are randomized to experimental condition arm 2 will be offered patient education treatment and internet delivered cognitive behavior therapy (iCBT) treatment. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Eligible participants are children and young people aged 8-14.
- Diagnosed with functional abdominal pain disorders by their physician.
- Diagnosed at one of the participating primary care health centres.
Key exclusion criteria (2 listed)
- Children and young people with scores above the clinical cut-off on the Revised Child Anxiety and Depression Scale (RCADS).
- Children who do not follow the mainstream Swedish National Curriculum due to learning disabilities.
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 |
|---|---|---|
| Digital patient educationThis educative intervention includes both medical and psychological explanations, as well as basic strategies to manage pediatric FAPD. The medical information spans the topics of pain, functional abdominal pain and general advice in terms of child health, and the psychological information is based on cognitive-behavioural and pain management theoretical approaches. The intervention consists of six short, animated films with a total run-time of approximately 30 minutes. The films each cover one of the following topics; Why and how do we feel pain? What is functional abdominal pain? How to help: general advice, Thoughts, feelings and behaviour, Goals and strategies. The films are accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform that is recognised by the care provider as meeting current safety criteria and standards. | Other | Intervention level 1 - patient education treatment. |
| Digital patient education and iCBTThis includes the educative intervention and a fully digital, four session version of the Aim to Decrease Anxiety and Pain Treatment (ADAPT), a CBT treatment program for FAPD. The treatment focuses on pain-management through the following core elements; The Pain-Gate Theory, breathing and relaxation strategies, calming statements, activity pacing, problem solving and behavior activation. This intervention is also accessed by the patient via 1177.se and maintained on the SoB (Stöd- och behandling) platform. | Other | Intervention level 2 - patient education and iCBT |
Primary outcome
Change from baseline in pain related functional disability.
Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion
Functional disability is measured with the child report version of the Functional Disabilities Inventory (FDI). The FDI is a 15-item measure of difficulty in performing activities in the past several days, valid for youth with chronic pain, and is used in FAPD. Items are rated on a 5-point Likert scale, ranging from 0 to 4 ("No Trouble" to "Impossible") and summed to create a total score (range 0-60). Higher scores indicate greater disability.
Change from baseline in pain intensity.
Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion.
Level of pain intensity will be obtained using a Visual Analogue Scale (VAS) 0-10. Higher scores indicate greater pain intensity.
Change from baseline in gastro symptom related worry.
Time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion
Child version of the Visceral Sensitivity Index (VSI-C) will be used to measure level of gastro-symptom related worry. The VSI-C is a 7-item rating scale, valid for children with functional abdominal pain disorders. Worry is rated 1-6 where higher scores indicate greater gastro-symptom related worry. Scores are summed to create a total score (range 0-42).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 28906315Cunningham NR, Nelson S, Jagpal A, Moorman E, Farrell M, Pentiuk S, Kashikar-Zuck S. Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):16-20. doi: 10.1097/MPG.0000000000001714.
- Background: PubMed 15680928Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.
- Background: PubMed 33130153Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.
- Background: PubMed 16480823Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
- Background: PubMed 35545865Lalouni M, Olen O, Bjureberg J, Bonnert M, Chalder T, Hedman-Lagerlof E, Reme SE, Serlachius E, Ljotsson B. Validation of child-adapted short scales for measuring gastrointestinal-specific avoidance and anxiety. Acta Paediatr. 2022 Aug;111(8):1621-1627. doi: 10.1111/apa.16403. Epub 2022 May 27.
- Individual participant dataSharing planned: Yes. 1. Ethical and Legal Considerations: * Data will be anonymized per data protection laws to safeguard patient privacy. * Researchers must sign a data sharing agreement detailing data use, security measures, and confidentiality requirements. 2. Ethics Committee Approval: * Documentation of approval from a relevant ethics committee is required to ensure ethical soundness. 3. Scope and Responsibility: * Requesters must describe the intended data use and ensure data is not used for other purposes without consent. * Findings from data use must be shared with us before publication. 4. Security Measures: * Researchers must show that appropriate technical and organizational measures are in place for secure data handling and storage.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital patient education and Digital patient education and iCBT in people with Functional Abdominal Pain Syndrome, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Weineland, PhD (+46 708735788, sandra.weineland@vgregion.se, sandra.weineland@psy.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain related functional disability. (time frame: Within a week after intervention completion, 6 months after completion and 12 months after completion). The study lists 3 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 NCT06481072, which also lists 5 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 1 Jul 2024.