Back to resultsInternet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Primary Purpose
Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered CBT
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-related functional gastrointestinal disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Child and Adolescent Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-delivered CBT
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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)
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).
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).
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.
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).
Full Information
NCT ID
NCT02033161
First Posted
December 5, 2013
Last Updated
January 9, 2014
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02033161
Brief Title
Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Official Title
Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
Keywords
Functional gastrointestinal disorders, FGID, Recurrent abdominal pain, Abdominal pain, pain-related functional gastrointestinal disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered CBT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT
Other Intervention Name(s)
Internet-delivered Exposure-based Cognitive Behavior Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gastrointestinal symptoms from baseline to 8 weeks, and from baseline to 6 months after treatment.
Description
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).
Time Frame
Baseline to 8 weeks, baseline to 8 months.
Secondary Outcome Measure Information:
Title
Change in pain reactivity from baseline to 8 weeks, and from baseline to 6 months after treatment.
Description
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).
Time Frame
Baseline to 8 weeks, baseline to 8 months.
Title
Change in pain interference on activities from baseline to 8 weeks, and baseline to 6 months after treatment.
Description
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)
Time Frame
Baseline to 8 weeks, baseline to 8 months.
Title
Change in function from baseline to 8 weeks and from baseline to 6 months after treatment.
Description
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).
Time Frame
Baseline to 8 weeks, baseline to 8 months.
Title
Change in sensitivity to symptoms of anxiety from baseline to 8 weeks, and from baseline to 6 months after treatment.
Description
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).
Time Frame
Baseline to 8 weeks, baseline to 8 months.
Title
Change in level of depression from baseline to 8 weeks and from baseline to 6 months after treatment.
Description
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.
Time Frame
Baseline, 8 weeks and 8 months.
Title
Change in level of perceived stress from baseline to 8 weeks and from baseline to 6 months after treatment.
Description
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).
Time Frame
Baseline, 8 weeks and 8 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brjánn Ljótsson, PhD
Organizational Affiliation
Departement of clinical neuropsychology, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatry
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
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Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
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