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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Irritable Bowel Syndrome; Functional Abdominal Pain; Functional Gastrointestinal Disorders
• Intervention / Treatment: Behavioral: Exposure-based internet-delivered CBT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Department of Clinical Neuroscience, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Internet-delivered CBT; Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 10 weeks	Baseline to 10 weeks
Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 3 months follow-up.	Baseline to 5 months.
Pain intensity (Faces Pain rating scale)	Change in pain intensity from baseline to 6 months follow-up.	Baseline to 8 months.
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.
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.
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
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.
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.
Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 10 weeks.	Baseline to 10 weeks.
Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 3 months follow-up.	Baseline to 5 months.
Fear for symptoms (Visceral sensitivity index)	Change in fear for symptoms from baseline to 6 months follow-up.	Baseline to 8 months.
Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 10 weeks.	Baseline to 10 weeks
Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 3 months follow-up.	Baseline to 5 months.
Avoidant behavior (IBS-BRQ)	Change in avoidant behavior from baseline to 6 months follow-up.	Baseline to 8 months.
Quality of life (PedsQL)	Change in quality of life from baseline to 10 weeks.	Baseline to 10 weeks.
Quality of life (PedsQL)	Change in quality of life from baseline to 3 months follow-up.	Baseline to 5 months.
Quality of life (PedsQL)	Change in quality of life from baseline to 6 months follow-up.	Baseline to 8 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 10 weeks.	Baseline to 10 weeks.
Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 3 months follow-up.	Baseline to 5 months.
Parental responses to children´s symptom behavior (ARCS)	Change in parental responses from baseline to 6 months follow-up.	Baseline to 8 months.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Marianne Bonnert, PhD, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 17, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Dyspepsia; Irritable Bowel Syndrome; Abdominal Pain; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: FGID IMP 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No