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Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02033161
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Brjann Ljotsson, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Functional Gastrointestinal Disorders Behavioral: Internet-delivered CBT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-delivered CBT Behavioral: Internet-delivered CBT

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.

Other Name: Internet-delivered Exposure-based Cognitive Behavior Therapy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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. ]
    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).

  2. 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. ]
    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)

  3. 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. ]
    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).

  4. 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. ]
    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).

  5. 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. ]
    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.

  6. 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. ]
    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).



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033161


Locations
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Sweden
Child and Adolescent Psychiatry
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Brjánn Ljótsson, PhD Departement of clinical neuropsychology, Karolinska Institutet

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Responsible Party: Brjann Ljotsson, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02033161     History of Changes
Other Study ID Numbers: icbt fgid pilot 2012
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Brjann Ljotsson, Karolinska Institutet:
Functional gastrointestinal disorders
FGID
Recurrent abdominal pain
Abdominal pain
pain-related functional gastrointestinal disorders
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Gastrointestinal Diseases
Disease
Digestive System Diseases
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases