Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02033161|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Functional Gastrointestinal Disorders||Behavioral: Internet-delivered CBT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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).
- 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).
- 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)
- 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).
- 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).
- 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.
- 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).
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
|Child and Adolescent Psychiatry|
|Principal Investigator:||Brjánn Ljótsson, PhD||Departement of clinical neuropsychology, Karolinska Institutet|