Functional Gastrointestinal Disorders (FGID)CBTNCT02113605
Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders
A study testing Cognitive behavior therapy in people with Functional Gastrointestinal Disorders (FGID) and FGID According to the Rome III Criteria, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Functional Gastrointestinal Disorders (FGID), FGID According to the Rome III Criteria, Irritable Bowel Syndrome (IBS)
- What is being tested?
- Cognitive behavior therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Nov 2015
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 8-12 years
- A diagnosis of a functional gastrointestinal disorder by a treating physician
Who cannot join
- Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
- Psychiatric disorder more urgent to treat than the abdominal pain.
- On-going psychological treatment.
- Absence from school more than 40 %.
- Ongoing maltreatment, violence or severe parental psychiatric illness.
- Pronounced language or learning difficulties that hinder the child to benefit from the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.
- Conditions
- Functional Gastrointestinal Disorders (FGID), FGID According to the Rome III Criteria, Irritable Bowel Syndrome (IBS), Functional Abdominal Pain, Functional Dyspepsia
- Being tested
- Cognitive behavior therapy
- Keywords
- Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyOther
Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | All included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm. Receives: Other: Cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
Measured: Baseline and 10 weeks
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.
Measured: Baseline and 8 months.
Secondary outcomes (20)
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks
Measured: Baseline and 10 weeks.
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks
Measured: Baseline and 10 weeks.
Change in Functional Disability Index (FDI) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Pain Reactivity Scale from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Child Depression Inventory (CDI) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Pain Interference Index (PII) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.
Measured: Baseline and 10 weeks.
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.
Measured: Baseline and 8 months
Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months
Measured: Baseline and 8 months.
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Functional Disability Index (FDI) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Child Depression Inventory (CDI) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Pain Interference Index (PII) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.
Measured: Baseline and 8 months.
Change in Pain Reactivity Scale from baseline to 8 months.
Measured: Baseline and 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal Disorders (FGID)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Olen, Karolinska Institutet
- Investigators
- Ola Olén, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113605
- Sponsor's protocol ID
- FGID Child Pilot-0
- Acronym
- CBT
- Status last verified
- Dec 2015
- First submitted
- 1 Apr 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol
- ClinicalTrials.gov ID
- NCT02113605
- Acronym / sponsor ID
- CBT / FGID Child Pilot-0
- Conditions
- Functional Gastrointestinal Disorders (FGID), FGID According to the Rome III Criteria, Irritable Bowel Syndrome (IBS), Functional Abdominal Pain, Functional Dyspepsia
- Keywords
- Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-predominant functional gastrointestinal disorders, Pediatric pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Apr 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.
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Other: Cognitive behavior therapyAll included children are treated with a face-to-face exposure-based cognitive behaviour therapy for 10 weeks. There will be no comparison arm. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 8-12 years
- A diagnosis of a functional gastrointestinal disorder by a treating physician
Key exclusion criteria (6 listed)
- Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
- Psychiatric disorder more urgent to treat than the abdominal pain.
- On-going psychological treatment.
- Absence from school more than 40 %.
- Ongoing maltreatment, violence or severe parental psychiatric illness.
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 |
|---|---|---|
| Cognitive behavior therapyExposure-based cognitive behavior therapy in a 10 week face-to-face treatment | Other | Cognitive behavior therapy |
Primary outcome
Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks
Time frame: Baseline and 10 weeks
Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.
Time frame: Baseline and 8 months.
20 secondary outcomes
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks
Time frame: Baseline and 10 weeks.
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks
Time frame: Baseline and 10 weeks.
Change in Functional Disability Index (FDI) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Pain Reactivity Scale from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Child Depression Inventory (CDI) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Pain Interference Index (PII) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.
Time frame: Baseline and 10 weeks.
Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.
Time frame: Baseline and 8 months
Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months
Time frame: Baseline and 8 months.
Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Functional Disability Index (FDI) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Child Depression Inventory (CDI) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Pain Interference Index (PII) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.
Time frame: Baseline and 8 months.
Change in Pain Reactivity Scale from baseline to 8 months.
Time frame: Baseline and 8 months.
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 2 Dec 2015.
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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.
Ola Olén, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Functional Gastrointestinal Disorders (FGID) and FGID According to the Rome III Criteria, run by Karolinska Institutet 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 2 inclusion and 6 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 2 Dec 2015. 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 Faces Pain Rating Scale (FACES) from baseline to 10 weeks (time frame: Baseline and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.