Department of Clinical Neuroscience, Karolinska Institutet
Stockholm, Sweden
NCT Number: NCT03252743
This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.
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Notify Me8 year–17 year
All sexes
Interventional
Not applicable
Stockholm, Sweden
Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and adolescents and associated with impaired quality of life. Our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to reduced symptoms and increased quality of life in children and adolescents with P-FGIDs. There is therefore reason to investigate how the treatment should be disseminated in regular care. This open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.
Method: Open trial with a pretest-posttest-design and no control group. The internet-delivered CBT-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. Assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion.
Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat analysis using Cohens' d and Student's t-test.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.
The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.
All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.
Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.
Time frame: Baseline to 10 weeks.
Change in global gastrointestinal symptoms from baseline to 10 weeks.
Time frame: Baseline to 10 weeks
Change in pain intensity from baseline to 10 weeks
Time frame: Baseline to 5 months.
Change in pain intensity from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in pain intensity from baseline to 6 months follow-up.
Time frame: Baseline to 5 months.
Change in global gastrointestinal symptoms from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in global gastrointestinal symptoms from baseline to 6 months follow-up.
Time frame: Baseline to 10 weeks
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.
Time frame: Baseline to 5 months.
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.
Time frame: Baseline to 8 months.
Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.
Time frame: Baseline to 10 weeks.
Change in fear for symptoms from baseline to 10 weeks.
Time frame: Baseline to 5 months.
Change in fear for symptoms from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in fear for symptoms from baseline to 6 months follow-up.
Time frame: Baseline to 10 weeks
Change in avoidant behavior from baseline to 10 weeks.
Time frame: Baseline to 5 months.
Change in avoidant behavior from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in avoidant behavior from baseline to 6 months follow-up.
Time frame: Baseline to 10 weeks.
Change in quality of life from baseline to 10 weeks.
Time frame: Baseline to 5 months.
Change in quality of life from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in quality of life from baseline to 6 months follow-up.
Time frame: Baseline to 10 weeks.
Change in parental responses from baseline to 10 weeks.
Time frame: Baseline to 5 months.
Change in parental responses from baseline to 3 months follow-up.
Time frame: Baseline to 8 months.
Change in parental responses from baseline to 6 months follow-up.
Karolinska Institutet
Other
Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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