Functional Gastrointestinal DisordersNCT02475096
Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
A study testing Internet-delivered CBT in people with Functional Gastrointestinal Disorders, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Internet-delivered CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesSweden
- Study dates
- Jul 2015to Nov 2016
- 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
- Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- Any psychopharmacological medication should be stable since 1 month.
- Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.
Who cannot join
- Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
- Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Child and Adolescent Psychiatry in Stockholm
Stockholm, Stockholms Lans Landsting, 11330
Child and Adolescent Psychiatry in Stockholm
Stockholm, 11330
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Internet-delivered CBT
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results.
Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Children and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists. Receives: Behavioral: Internet-delivered CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months
Secondary outcomes (24)
Faces Pain Rating Scale. (FACES)
Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 2 weeks after 9 months for analysis of effect.The Faces Pain Scale is a self-report measure used to assess the intensity of children's pain. Faces have four faces representing least pain and most pain on equal intervals on a scale from 0-10. Its validity is supported by a strong positive correlation (r=0.93, N=76) with a visual analogue scale (VAS) measure in children aged 5-12 years. The metric for scoring (0-10) conforms closely to a linear interval scale.
Measured: Baseline to 10 weeks, baseline to 9 months
Faces Pain Rating Scale. (FACES)
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
The Pain App
Change in pain intensity and daily frequency reported daily during two weeks at baseline, after treatment and at 9 months with a mobile phone application developed by the research group.
Measured: Baseline to 10 weeks, baseline to 9 months
Pediatric Quality of Life Inventory (PedsQL)
Change in quality of life from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures quality of life in adolescents. PedsQL Generic Core scales is a 23-item scale ranging from 0 (never) to 4 (almost always). The PedsQL is shown to distinguish between healthy children and adolescents and pediatric patients with acute or chronic health conditions and demonstrate acceptable reliability and validity.
Measured: Baseline to 10 weeks, baseline to 9 months
Children´s Somatization Inventory (CSI 24)
Change in inner symptoms from baseline to 10 weeks, baseline to 9 months, measured with a self-report scale that measures inner symptoms (e.g., headache, nausea, heart racing) that often, but not necessarily, occur in the absence of identified disease, in children and adolescents. CSI-24 is a 24-item scale ranging from ranging from 0 '(not at all) to 4 (a whole lot).
Measured: Baseline to 10 weeks, baseline to 9 months
Functional Disability Index (FDI)
Change in school attendance from baseline to 10 weeks, baseline to 9 months measured with 2 items from a self-report scale that measures school attendance.
Measured: Baseline to 10 weeks, baseline to 9 months
Insomnia Severity Index (ISI)
Change in problematic sleeping patterns from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures sleeping habits.
Measured: Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
Change in Gastrointestinal symptom-specific behaviors measured with a self-rating scale weekly during treatment for mediation analyses, and from baseline to 10 weeks, baseline to 9 months, for analysis of effect.
Measured: Baseline to 10 weeks, baseline to 9 months
Spence Children Anxiety Scale - short version (SCAS)
Change in anxiety symptoms from baseline to 10 weeks, baseline to 9 months with a self-report scale that measures anxiety symptoms in children and adolescents.
Measured: Baseline to 10 weeks, baseline to 9 months
Child Depression Inventory - short version (CDI-S)
Change in level of depression from baseline to 10 weeks and from baseline to 9 months measured with a self-report scale that measures depression in children and adolescents.
Measured: Baseline to 10 weeks, baseline to 9 months
Pain Response Inventory (PRI) - subscale Coping
Change in pain coping from baseline to 10 weeks and from baseline to 9 months measured with a self-report scale that measures pain coping strategies.
Measured: Baseline to 10 weeks, baseline to 9 months
Pressure Activation Stress Scale (PAS)
Change in stress levels från baseline to 10 weeks and från baseline to 9 months measured with a self-report scale that measures perceived stress. The PAS is developed for children and validated for the age group.
Measured: Baseline to 10 weeks, baseline to 9 months
Visceral Sensitivity Index (IBS-VSI)
Change in visceral sensitivity from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures gastrointestinal symptom-specific anxiety.
Measured: Baseline to 10 weeks, baseline to 9 months
Client satisfactory questionnaire (CSQ)
Self-rating scale that measures satisfaction with treatment after completion.
Measured: At 10 weeks
Subjective Assessment Questionnaire (SAQ)
Self-rating scale that measures subjective change in symptoms as an effect of treatment.
Measured: At 10 weeks
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
IBS-behavioral responses questionnaire (IBS-BRQ)
Change in gastrointestinal symptoms-specific behavior measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9)
ROME-III Questionnaire
Change in children's functional gastrointestinal disorders diagnostic status measured by ROME-III as a self-rating scale.
Measured: Baseline to 10 weeks, baseline to 9 months
Adverse Events (AE)
Self-rating scale that measures adverse events related to treatment.
Measured: At 10 weeks
Generalized Anxiety Disorder Screener (GAD-7)
Change in anxiety levels in parents from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures anxiety symptoms. GAD-7 is a 7-item scale ranging from 0 (not at all) to 3 (almost every day). Evidence supports reliability and validity of the GAD-7 as a measure of anxiety in the general population.
Measured: Baseline to 10 weeks, baseline to 9 months
Patient Health Questionnaire (PHQ 9)
Change in depression levels in parents from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures depression. PHQ-9 is shown to be a reliable and valid measure of depression severity in adults.
Measured: Baseline to 10 weeks, baseline to 9 months
Adult Responses to Children's Symptoms (ARCS)
Change in parents responses to their children's abdominal pain from baseline to 10 weeks, baseline to 9 months measured with a self-report scale assessing protectiveness, minimizing, and encouraging responses to children's pain behavior.
Measured: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Change in parental behavior from baseline to 10 weeks, baseline to 9 months measured with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
Measured: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Change in parental behavior measured weekly with a self-report scale assessing common responses to children´s gastrointestinal symptoms.
Measured: Weekly during treatment (treatment week 1-9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
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
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT02475096
- Sponsor's protocol ID
- Pilot child ICBT FGID
- Status last verified
- Mar 2017
- First submitted
- 15 Jun 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
- ClinicalTrials.gov ID
- NCT02475096
- Acronym / sponsor ID
- Pilot child ICBT FGID
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Jun 2015 (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.
This pilot-study aims to evaluate the effect size and feasibility of internet-delivered cognitive behavior therapy (ICBT) for children (age 8-12 years) with pain-predominant functional gastrointestinal disorders (e.g. irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria). The main component investigated in this study is exposure for gastrointestinal symptoms and for feared stimuli and situations. Children will participate along with one of their parents in the treatment. The parents will also receive specific modules with information on how to support their child in the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Internet-delivered CBTChildren and parents will receive 10 weekly modules of internet-delivered CBT (Cognitive Behavior Therapy). Parents will also receive 10 weekly specific modules for parents. Main components in the modules directed at children and parents are exposure for symptoms, feared stimuli and situations. The parents modules contain information on how they can support their children in the treatment and is based on social learning theory. Therapist support is provided through written messages within the secure platform. Therapists are trained CBT-psychologists. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 8-12 years (until their 13th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
- Any psychopharmacological medication should be stable since 1 month.
- Parents and children need to master Swedish, have access to a computer with internet access, and be willing to participate in 10 weeks of treatment with homework.
Key exclusion criteria (2 listed)
- Simultaneous presence of serious somatic disease and / or if the child meets the criteria for other organic disease which better explains the symptoms.
- Psychiatric or social problems that are considered serious and in need of a more intense treatment than ICBT leads to exclusion. Children with higher school absenteeism than 40% will not be included. Neither will children who have an ongoing psychological treatment be included,
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 |
|---|---|---|
| Internet-delivered CBTThe treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results. Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire. | Behavioural | Internet-delivered CBT |
Primary outcome
PedsQL Gastro
Time frame: Baseline to 10 weeks, baseline to 9 months
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.
24 secondary outcomes
Faces Pain Rating Scale. (FACES)
Time frame: Baseline to 10 weeks, baseline to 9 months
Faces Pain Rating Scale. (FACES)
Time frame: Weekly during treatment (treatment week 1-9)
The Pain App
Time frame: Baseline to 10 weeks, baseline to 9 months
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline to 10 weeks, baseline to 9 months
Children´s Somatization Inventory (CSI 24)
Time frame: Baseline to 10 weeks, baseline to 9 months
Functional Disability Index (FDI)
Time frame: Baseline to 10 weeks, baseline to 9 months
Insomnia Severity Index (ISI)
Time frame: Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
Time frame: Baseline to 10 weeks, baseline to 9 months
Spence Children Anxiety Scale - short version (SCAS)
Time frame: Baseline to 10 weeks, baseline to 9 months
Child Depression Inventory - short version (CDI-S)
Time frame: Baseline to 10 weeks, baseline to 9 months
Pain Response Inventory (PRI) - subscale Coping
Time frame: Baseline to 10 weeks, baseline to 9 months
Pressure Activation Stress Scale (PAS)
Time frame: Baseline to 10 weeks, baseline to 9 months
Visceral Sensitivity Index (IBS-VSI)
Time frame: Baseline to 10 weeks, baseline to 9 months
Client satisfactory questionnaire (CSQ)
Time frame: At 10 weeks
Subjective Assessment Questionnaire (SAQ)
Time frame: At 10 weeks
PedsQL Gastro
Time frame: Weekly during treatment (treatment week 1-9)
IBS-behavioral responses questionnaire (IBS-BRQ)
Time frame: Weekly during treatment (treatment week 1-9)
ROME-III Questionnaire
Time frame: Baseline to 10 weeks, baseline to 9 months
Adverse Events (AE)
Time frame: At 10 weeks
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: Baseline to 10 weeks, baseline to 9 months
Patient Health Questionnaire (PHQ 9)
Time frame: Baseline to 10 weeks, baseline to 9 months
Adult Responses to Children's Symptoms (ARCS)
Time frame: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time frame: Baseline to 10 weeks, baseline to 9 months
Parental Behavior in Response to Children's Functional Gastrointestinal Disorders
Time frame: Weekly during treatment (treatment week 1-9)
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 Mar 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered CBT in people with Functional Gastrointestinal Disorders, run by Karolinska Institutet at 2 sites 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: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PedsQL Gastro (time frame: Baseline to 10 weeks, baseline to 9 months). 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 3 Mar 2017.