Irritable Bowel SyndromeNCT02033161
Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
A study testing Internet-delivered CBT in people with Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, 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 for adolescents with functional gastrointestinal disorders. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome, 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
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Jun 2013
- 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 between 13 and 17 years old.
- a diagnosis of a functional gastrointestinal disorder by treating physician, e.g. IBS, FD or FAP.
- adolescent and one parent should have easy access to the Internet, some computer experience and good Swedish language skills.
Who cannot join
- concurrent serious medical conditions or gastrointestinal symptoms likely caused by an organic disorder.
- psychiatric diagnosis more urgent to treat than the abdominal pain.
- on-going psychological treatment.
- absence from school more than 20%.
- on-going maltreatment, violence or severe parental psychiatric illness in the family.
- pronounced language and learning difficulties depending on whether the youth was expected to benefit from the treatment or not.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.
Read the detailed description
Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional abdominal pain (FAP), 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 FGID.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program lasted for 8 weeks and included weekly therapist support, consisting of online messages and telephone calls. Assessment points were baseline, post-treatment and 6 months follow-up.
Analysis: Effect sizes and within-group differences were calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.
- Being tested
- Internet-delivered CBT
- Keywords
- Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-related functional gastrointestinal disorders
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
Also called Internet-delivered Exposure-based Cognitive Behavior Therapy
The internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention.
Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention.
The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Not described Receives: Behavioral: Internet-delivered CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
Measured with a self-report scale, GSRS-IBS, that have 13 items about weekly gastro-intestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale, from 1 ("no trouble 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 8 weeks, baseline to 8 months.
Secondary outcomes (6)
Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.
Measured with a self-report scale, pain reactivity scale (PRS), that 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 8 weeks, baseline to 8 months.
Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.
Measured with a self-report scale, pain interference index (PII), that 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 8 weeks, baseline to 8 months.
Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.
Measured with a self-report scale, functional disability index (FDI), with 15 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 8 weeks, baseline to 8 months.
Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.
Measured by a self-report scale called Childhood Anxiety Sensitivity Index (CASI) with 18 items. It is a 3-point scale (1-3), which measures sensitivity to internal sensations that could be symptoms of anxiety. The questions include items such as "I get scared when I feel shaky" or "I get scared when my heart beats fast" but also items that could be gastro-intestinal symptoms, such as "When my stomach hurts, I worry that i might be really sick "(Silverman, Fleisig, Rabian, \& Peterson, 1991). CASI has been reported to have high reliability, α = .84 (Silverman et al. 1991).
Measured: Baseline to 8 weeks, baseline to 8 months.
Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.
Measured by the self-report scale Child depression Inventory (CDI) that consists of 27 items on a 3-graded scale (0-2). The scale's psychometric properties have been validated in a study by Smucker, Craighead and Green (1986), which found that the internal consistency measured by Cronbach's alpha was acceptable, between α = .83 and α = .89.
Measured: Baseline, 8 weeks and 8 months.
Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.
Measured by a four-item short version of a self-report scale, Percieved Stress Scale (PSS-4). PSS-4 consists of four statements about the feeling of being able to control and sort out problems that need to be managed. Responses are rated from 0 ("never") to 4 ("very often"). Reliability for the version with 4 items is α = .72 (Cohen et al., 1983).
Measured: Baseline, 8 weeks 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 posted10 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- 29 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, Departement of clinical neuropsychology, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033161
- Sponsor's protocol ID
- icbt fgid pilot 2012
- Status last verified
- Jan 2014
- First submitted
- 5 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT02033161
- Acronym / sponsor ID
- icbt fgid pilot 2012
- Keywords
- Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-related functional gastrointestinal disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Jan 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 for adolescents with functional gastrointestinal disorders.
Detailed description
Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS), functional dyspepsia (FD) and functional abdominal pain (FAP), 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 FGID.
Method: Pilot study with a pre-post-design and no control group. The internet-delivered CBT-program lasted for 8 weeks and included weekly therapist support, consisting of online messages and telephone calls. Assessment points were baseline, post-treatment and 6 months follow-up.
Analysis: Effect sizes and within-group differences were 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
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Internet-delivered CBT |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 13 and 17 years old.
- a diagnosis of a functional gastrointestinal disorder by treating physician, e.g. IBS, FD or FAP.
- adolescent and one parent should have easy access to the Internet, some computer experience and good Swedish language skills.
Key exclusion criteria (6 listed)
- concurrent serious medical conditions or gastrointestinal symptoms likely caused by an organic disorder.
- psychiatric diagnosis more urgent to treat than the abdominal pain.
- on-going psychological treatment.
- absence from school more than 20%.
- on-going maltreatment, violence 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 CBTAlso: Internet-delivered Exposure-based Cognitive Behavior TherapyThe internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention. Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention. The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment. | Behavioural | Internet-delivered CBT |
Primary outcome
Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
Time frame: Baseline to 8 weeks, baseline to 8 months.
Measured with a self-report scale, GSRS-IBS, that have 13 items about weekly gastro-intestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale, from 1 ("no trouble 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).
6 secondary outcomes
Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.
Time frame: Baseline to 8 weeks, baseline to 8 months.
Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.
Time frame: Baseline to 8 weeks, baseline to 8 months.
Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.
Time frame: Baseline to 8 weeks, baseline to 8 months.
Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.
Time frame: Baseline to 8 weeks, baseline to 8 months.
Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.
Time frame: Baseline, 8 weeks and 8 months.
Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.
Time frame: Baseline, 8 weeks 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 10 Jan 2014.
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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
Departement of clinical neuropsychology, 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 Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, 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 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 10 Jan 2014. 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 gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment. (time frame: Baseline to 8 weeks, baseline to 8 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 10 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.