ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

Irritable Bowel Syndrome Clinical Trial

Official title:

Internet-delivered Exposure-based Cognitive Behavior Therapy for Pain-predominant Functional Gastrointestinal Disorders in Children and Adolescents: an Implementation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252743
• Other study ID #: FGID IMP 2017
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 18, 2018

Study information

• Verified date: February 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 18, 2018
• Est. primary completion date: June 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age 8-17 at date of inclusion.

• Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.

• Stable psychotropic medication for at least 1 month.

Exclusion Criteria:

• concurrent serious medical conditions.

• a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.

• on-going structured psychological treatment.

• absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in ICBT.

• on-going abuse or severe parental psychiatric illness in the family.

• since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study.

• lack of regular internet-access.

Related Conditions & MeSH terms

• Abdominal Pain
• Digestive System Diseases
• Dyspepsia
• Functional Abdominal Pain
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome

Intervention

Behavioral:
• Exposure-based internet-delivered CBT
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.

Locations

Country	Name	City	State
Sweden	Department of Clinical Neuroscience, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 10 weeks.	Baseline to 10 weeks.
Other	Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 3 months follow-up.	Baseline to 5 months.
Other	Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 6 months follow-up.	Baseline to 8 months.
Primary	Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).	Change in global gastrointestinal symptoms from baseline to 10 weeks.	Baseline to 10 weeks.
Secondary	Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 10 weeks	Baseline to 10 weeks
Secondary	Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 3 months follow-up.	Baseline to 5 months.
Secondary	Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 6 months follow-up.	Baseline to 8 months.
Secondary	Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).	Change in global gastrointestinal symptoms from baseline to 3 months follow-up.	Baseline to 5 months.
Secondary	Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).	Change in global gastrointestinal symptoms from baseline to 6 months follow-up.	Baseline to 8 months.
Secondary	Gastrointestinal symptoms module (PedsQL Gastro)	Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 10 weeks.	Baseline to 10 weeks
Secondary	Gastrointestinal symptoms module (PedsQL Gastro)	Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 3 months follow up.	Baseline to 5 months.
Secondary	Gastrointestinal symptoms module (PedsQL Gastro)	Change in different dimensions of gastrointestinal symptoms (e.g. pain-related symptoms, nausea, bloating) from baseline to 6 months follow up.	Baseline to 8 months.
Secondary	Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 10 weeks.	Baseline to 10 weeks.
Secondary	Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 3 months follow-up.	Baseline to 5 months.
Secondary	Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 6 months follow-up.	Baseline to 8 months.
Secondary	Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 10 weeks.	Baseline to 10 weeks
Secondary	Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 3 months follow-up.	Baseline to 5 months.
Secondary	Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 6 months follow-up.	Baseline to 8 months.
Secondary	Quality of life (PedsQL)	Change in quality of life from baseline to 10 weeks.	Baseline to 10 weeks.
Secondary	Quality of life (PedsQL)	Change in quality of life from baseline to 3 months follow-up.	Baseline to 5 months.
Secondary	Quality of life (PedsQL)	Change in quality of life from baseline to 6 months follow-up.	Baseline to 8 months.

External Links

•   Research project homepage for studies on ICBT for pediatric FGIDs (in Swedish).