Functional Gastrointestinal DisordersNCT03252743
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
A study testing Exposure-based internet-delivered CBT in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia
- What is being tested?
- Exposure-based internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 18 Dec 2018
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-17 at date of inclusion.
- Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
- Stable psychotropic medication for at least 1 month.
Who cannot join
- concurrent serious medical conditions.
- a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
- on-going structured psychological treatment.
- absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.
- on-going abuse or severe parental psychiatric illness in the family.
- since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.
- lack of regular internet-access.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Neuroscience, Karolinska Institutet
Stockholm
About this study
Official title: Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.
Read the detailed description
Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.
Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.
Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.
- Conditions
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain
- Being tested
- Exposure-based internet-delivered CBT
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure-based internet-delivered CBTBehavioural
The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.
The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.
All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.
Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet. Receives: Behavioral: Exposure-based internet-delivered CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 10 weeks.
Measured: Baseline to 10 weeks.
Secondary outcomes (17)
Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 10 weeks
Measured: Baseline to 10 weeks
Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 3 months follow-up.
Measured: Baseline to 5 months.
Pain intensity (Faces Pain rating scale)
Change in pain intensity from baseline to 6 months follow-up.
Measured: Baseline to 8 months.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 3 months follow-up.
Measured: Baseline to 5 months.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
Measured: Baseline to 8 months.
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.
Measured: Baseline to 10 weeks
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.
Measured: Baseline to 5 months.
Gastrointestinal symptoms module (PedsQL Gastro)
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
Measured: Baseline to 8 months.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 10 weeks.
Measured: Baseline to 10 weeks.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 3 months follow-up.
Measured: Baseline to 5 months.
Fear for symptoms (Visceral sensitivity index)
Change in fear for symptoms from baseline to 6 months follow-up.
Measured: Baseline to 8 months.
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 10 weeks.
Measured: Baseline to 10 weeks
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 3 months follow-up.
Measured: Baseline to 5 months.
Avoidant behavior (IBS-BRQ)
Change in avoidant behavior from baseline to 6 months follow-up.
Measured: Baseline to 8 months.
Quality of life (PedsQL)
Change in quality of life from baseline to 10 weeks.
Measured: Baseline to 10 weeks.
Quality of life (PedsQL)
Change in quality of life from baseline to 3 months follow-up.
Measured: Baseline to 5 months.
Quality of life (PedsQL)
Change in quality of life from baseline to 6 months follow-up.
Measured: Baseline to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2017
- Primary completion17 Jun 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Model description
- Open trial without control group to test feasibility and evaluate preliminary effects.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Bonnert, Karolinska Institutet
- Investigators
- Marianne Bonnert, PhD, Principal investigator, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252743
- Sponsor's protocol ID
- FGID IMP 2017
- Status last verified
- Feb 2019
- First submitted
- 14 Aug 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
- ClinicalTrials.gov ID
- NCT03252743
- Acronym / sponsor ID
- FGID IMP 2017
- Conditions
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome, Dyspepsia, Functional Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 17 Aug 2017 (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.
This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.
Detailed description
Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.
Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.
Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial without control group to test feasibility and evaluate preliminary effects.
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Exposure-based internet-delivered CBTExposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 8-17 at date of inclusion.
- Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
- Stable psychotropic medication for at least 1 month.
Key exclusion criteria (7 listed)
- concurrent serious medical conditions.
- a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
- on-going structured psychological treatment.
- absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.
- on-going abuse or severe parental psychiatric illness in the family.
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 |
|---|---|---|
| Exposure-based internet-delivered CBTThe main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges. The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment. All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment. Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises. | Behavioural | Internet-delivered CBT |
Primary outcome
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Time frame: Baseline to 10 weeks.
Change in global gastrointestinal symptoms from baseline to 10 weeks.
17 secondary outcomes
Pain intensity (Faces Pain rating scale)
Time frame: Baseline to 10 weeks
Pain intensity (Faces Pain rating scale)
Time frame: Baseline to 5 months.
Pain intensity (Faces Pain rating scale)
Time frame: Baseline to 8 months.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Time frame: Baseline to 5 months.
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).
Time frame: Baseline to 8 months.
Gastrointestinal symptoms module (PedsQL Gastro)
Time frame: Baseline to 10 weeks
Gastrointestinal symptoms module (PedsQL Gastro)
Time frame: Baseline to 5 months.
Gastrointestinal symptoms module (PedsQL Gastro)
Time frame: Baseline to 8 months.
Fear for symptoms (Visceral sensitivity index)
Time frame: Baseline to 10 weeks.
Fear for symptoms (Visceral sensitivity index)
Time frame: Baseline to 5 months.
Fear for symptoms (Visceral sensitivity index)
Time frame: Baseline to 8 months.
Avoidant behavior (IBS-BRQ)
Time frame: Baseline to 10 weeks
Avoidant behavior (IBS-BRQ)
Time frame: Baseline to 5 months.
Avoidant behavior (IBS-BRQ)
Time frame: Baseline to 8 months.
Quality of life (PedsQL)
Time frame: Baseline to 10 weeks.
Quality of life (PedsQL)
Time frame: Baseline to 5 months.
Quality of life (PedsQL)
Time frame: Baseline to 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 26 Feb 2019.
- 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.
Marianne Bonnert, PhD principal investigator
Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure-based internet-delivered CBT in people with Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, 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 3 inclusion and 7 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 26 Feb 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 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?
Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms). (time frame: Baseline to 10 weeks.). 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 26 Feb 2019.