Functional Gastrointestinal DisordersNCT02306941
Internet-delivered CBT for Functional Abdominal Pain in Adolescents - a Pilot
A study testing Internet-delivered CBT in people with Functional Gastrointestinal Disorders and Abdominal Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Abdominal Pain, Dyspepsia
- 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
- 1 siteSweden
- Study dates
- Mar 2015to Dec 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 13-17 at inclusion date
- fulfilling Rome III-criteria for FAP or FD with:
- a written diagnosis from patient's physician and negative required tests (Blood samples: C-reactive protein or erythrocyte sedimentation rate, Blood count and IgA-Transglutaminase. Stool: f-Calprotectin)
- The Rome III questionnaire + clinical interview confirming the diagnosis
Who cannot join
- Concurrent serious medical conditions
- Concurrent serous psychiatric diagnosis
- On-going psychological treatment
- Absence from school exceeding an average of 2 days a week is a cause for exclusion since high absence demands more intensive interventions than can be offered in ICBT
- On-going abuse or severe parental psychiatric illness in the family
- 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.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Functional Abdominal Pain in Adolescents - an Open Pilot.
This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.
Read the detailed description
Functional abdominal pain (FAP) and functional dyspepsia, are common in adolescents and associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with FAP and FD.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
- Being tested
- Internet-delivered CBT
- Medical subject headings
- Gastrointestinal Diseases, Abdominal Pain, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, adapted for adolescents with FAP/FD and their parents. 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 adolescents, 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 | 10 sessions of ICBT during 10 weeks for the adolescents. 5 session of parent training during 10 weeks for parents. Therapist support is provided at least once weekly through the platform developed for the purpose. 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.
Faces pain scale - R
Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 10th to 12th week post treatment 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 12 weeks.
Secondary outcomes (18)
Faces pain scale - R
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 9 months
Faces pain scale - R
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Measured: Weekly during treatment (treatment week 1-9).
Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS)
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.The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety).
Measured: Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
Change in Gastrintestinalsymptoms-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. The scale consists of 26 items on a seven-point Likert scale from 1 (never) to 7 (always). The scale includes items related to avoidance behavior such as "I avoid certain social situations (e.g. restaurants) because of my symptoms " and to toilet behavior such as "I spend more time on the toilet than ideally I would like". IBS-BRQ is both reliable and valid with a high degree of internal consistency for adults with IBS (Cronbach's α=.86). The scale differentiate significantly between IBS patients and healthy controls (F=221, P<.01).
Measured: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
Percieved Stress scale (PSS 10)
Change in perceived stress 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. The PSS measures the degree to which situations are appraised as stressful. It is a self-report scale with 10 items on daily hassles and the current feeling of being able to handle problems that need to be addressed. It is a five-point Likert scale ranging from 0 (never) to 4 (very often). It is a widely used questionnaire to measure perceived stress and has adequate internal and test-retest reliability.
Measured: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
Pain reactivity Scale (PRS)
Change in pain reactivity measured with a self-report scale, pain reactivity scale (PRS), at baseline to 10 weeks, baseline to 9 months. PRS have 5 items about reactivity to and worry about pain. Three items are about emotional reactions to current pain. Two items affect frequency of worry about not being able to do things now, and in the future because of the pain. Questions are answered on a 6-point scale from 0 ("not at all") to 6 ("very much"). PRS has been reported to have satisfactory psychometric properties (Wicksell et al, 2011)
Measured: Baseline to 10 weeks, baseline to 9 months,
Pain interference index (PII)
Change in pain interference measured with a self-report scale at baseline to 10 weeks, baseline to 9 months. Pain interference index (PII), have 6 items about interference on various activities because of pain. Questions are answered on a 6-point scale from 0 ("not at all") to 6 ("very much"). According to preliminary analysis, the instrument has satisfactory psychometric properties (Wicksell et al., 2011)
Measured: Baseline to 10 weeks, baseline to 9 months.
Functional disability index (FDI)
Change in function measured with a self-report scale at baseline to 10 weeks, baseline to 9 months, baseline to 15 months, baseline to 27 months. Functional disability index (FDI) have15 items on daily activities. Questions are related to specific activities such as climbing stairs, running 100 meters and to go shopping, and general activities such as eating meals and being in school all day. The scale ranges from 1 (no problem at all) to 5 (impossible). It is validated for children and adolescents with chronic abdominal pain with high internal consistency, α = .86 for boys and α = .91 for girls (Claar and Walker, 2006). FDI is the scale that is recommended in pediatric pain studies to measure the influence of pain on function (McGrath et al., 2008).
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. VSI is a 15-item scale and has a scale ranging from 0 (not at all) to 5 (totally agree). The scale has demonstrated excellent reliability as well as good content, convergent, divergent and predictive validity.
Measured: Baseline to 10 weeks, baseline to 9 months.
Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18
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 distinguishe 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.
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale
Change in gastrointestinal symptoms from baseline to 10 weeks, baseline to 9 months, measured with a self-report scale that measures gastrointestinal symptoms in children and adolescents. The PedsQL Gastro is a 9-item scale ranging from 0 (never) to 4 (almost always).
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, baseline to 15 months, baseline to 27 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.
Spence Children's Anxiety Scale (SCAS-C)
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. SCAS-C is a 45 -item scale ranging from ranging from 0 (never) to 3 (always). SCAS-C has demonstrated high internal consistency, high concurrent validity with other measures of child and adolescent anxiety, and adequate test-retest reliability.
Measured: Baseline to 10 weeks, baseline to 9 months.
TiC-P Adolescents revised version
Change in healthcare utilization and productivity loss from baseline to 10 weeks, baseline to 9 months, measured with a self-report scale that measures healthcare utilization and productivity. The scale has been revised to fit adolescents and consists in our study of 3 items assessing school absenteeism and 6 items assessing healthcare utilization.
Measured: Baseline to 10 weeks, baseline to 9 months.
TIC-P Parent report
Change in parents healthcare utilization and productivity loss from baseline to 10 weeks, baseline to 9 months measured with a self-report scale that measures healthcare utilization and productivity. TIC-P consists of 10 items.
Measured: Baseline to 10 weeks, baseline to 9 months
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. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). 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
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. The ARCS is a 29-item scale.
Measured: Baseline to 10 weeks, baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionDec 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, Brjann Ljotsson, Karolinska Institutet
- Investigators
- Brjánn Ljótsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306941
- Sponsor's protocol ID
- FAP pilot ICBT 2015
- Status last verified
- May 2017
- First submitted
- 30 Nov 2014
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Functional Abdominal Pain in Adolescents - an Open Pilot.
- ClinicalTrials.gov ID
- NCT02306941
- Acronym / sponsor ID
- FAP pilot ICBT 2015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 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.
This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.
Detailed description
Functional abdominal pain (FAP) and functional dyspepsia, are common in adolescents and associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to reduced symptoms and increased quality of life, but studies in children are lacking. This pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with FAP and FD.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.
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 CBT10 sessions of ICBT during 10 weeks for the adolescents. 5 session of parent training during 10 weeks for parents. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 13-17 at inclusion date
- fulfilling Rome III-criteria for FAP or FD with:
Key exclusion criteria (7 listed)
- Concurrent serious medical conditions
- Concurrent serous psychiatric diagnosis
- On-going psychological treatment
- Absence from school exceeding an average of 2 days a week is a cause for exclusion since high 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 |
|---|---|---|
| Internet-delivered CBTThe Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, adapted for adolescents with FAP/FD and their parents. 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 adolescents, 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
Faces pain scale - R
Time frame: Baseline to 12 weeks.
Change in pain intensity measured with a self-rating scale daily during 2 weeks at baseline and daily during 10th to 12th week post treatment 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.
18 secondary outcomes
Faces pain scale - R
Time frame: Baseline to 9 months
Faces pain scale - R
Time frame: Weekly during treatment (treatment week 1-9).
Gastrointestinal Symptom Rating Scale-IBS Version (GSRS-IBS)
Time frame: Baseline to 10 weeks, baseline to 9 months
IBS-behavioral responses questionnaire (IBS-BRQ)
Time frame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
Percieved Stress scale (PSS 10)
Time frame: Weekly during treatment (treatment week 1-9). Baseline to 10 weeks, baseline to 9 months.
Pain reactivity Scale (PRS)
Time frame: Baseline to 10 weeks, baseline to 9 months,
Pain interference index (PII)
Time frame: Baseline to 10 weeks, baseline to 9 months.
Functional disability index (FDI)
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.
Pediatric Quality of Life Inventory (PedsQL) Generic Core scales age 13-18
Time frame: Baseline to 10 weeks, baseline to 9 months.
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptom Scale
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.
Spence Children's Anxiety Scale (SCAS-C)
Time frame: Baseline to 10 weeks, baseline to 9 months.
TiC-P Adolescents revised version
Time frame: Baseline to 10 weeks, baseline to 9 months.
TIC-P Parent report
Time frame: Baseline to 10 weeks, baseline to 9 months
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
ARCS
Time frame: Baseline to 10 weeks, baseline to 9 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 16 May 2017.
- Individual participant dataSharing planned: No
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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.
Brjánn Ljótsson, 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 Internet-delivered CBT in people with Functional Gastrointestinal Disorders and Abdominal Pain, 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 4 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 16 May 2017. 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?
Faces pain scale - R (time frame: Baseline to 12 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 16 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.