Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02475096
• Date of registration: 15/06/2015
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: Internet-delivered CBT for Children With Functional Gastrointestinal Disorders - an Open Pilot Study
• Scientific title: Internet-delivered Cognitive Behavior Therapy for Children With Pain-predominant Functional Gastrointestinal Disorders - an Open Pilot Study
• Date of first enrolment: July 2015
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02475096
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Ola Olén, MD PhD
• Affiliation: Karolinska Institutet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children between 8-12 years (until their 13th birthday) who have been diagnosed with
any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional
abdominal pain according to the Rome III criteria.

- Any psychopharmacological medication should be stable since 1 month.

- Parents and children need to master Swedish, have access to a computer with internet
access, and be willing to participate in 10 weeks of treatment with homework.

Exclusion Criteria:

- Simultaneous presence of serious somatic disease and / or if the child meets the
criteria for other organic disease which better explains the symptoms.

- Psychiatric or social problems that are considered serious and in need of a more
intense treatment than ICBT leads to exclusion. Children with higher school
absenteeism than 40% will not be included. Neither will children who have an ongoing
psychological treatment be included,



Age minimum: 8 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Functional Gastrointestinal Disorders

Intervention(s)

Behavioral: Internet-delivered CBT

Primary Outcome(s)

PedsQL Gastro [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Secondary Outcome(s)

Adult Responses to Children's Symptoms (ARCS) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Patient Health Questionnaire (PHQ 9) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Child Depression Inventory - short version (CDI-S) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Client satisfactory questionnaire (CSQ) [Time Frame: At 10 weeks]

Insomnia Severity Index (ISI) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Pediatric Quality of Life Inventory (PedsQL) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Pressure Activation Stress Scale (PAS) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Pain Response Inventory (PRI) - subscale Coping [Time Frame: Baseline to 10 weeks, baseline to 9 months]

The Pain App [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Faces Pain Rating Scale. (FACES) [Time Frame: Weekly during treatment (treatment week 1-9)]

Generalized Anxiety Disorder Screener (GAD-7) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Faces Pain Rating Scale. (FACES) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Parental Behavior in Response to Children's Functional Gastrointestinal Disorders [Time Frame: Weekly during treatment (treatment week 1-9)]

Adverse Events (AE) [Time Frame: At 10 weeks]

Children´s Somatization Inventory (CSI 24) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Functional Disability Index (FDI) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

IBS-behavioral responses questionnaire (IBS-BRQ) [Time Frame: Weekly during treatment (treatment week 1-9)]

Parental Behavior in Response to Children's Functional Gastrointestinal Disorders [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Visceral Sensitivity Index (IBS-VSI) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

ROME-III Questionnaire [Time Frame: Baseline to 10 weeks, baseline to 9 months]

Spence Children Anxiety Scale - short version (SCAS) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

IBS-behavioral responses questionnaire (IBS-BRQ) [Time Frame: Baseline to 10 weeks, baseline to 9 months]

PedsQL Gastro [Time Frame: Weekly during treatment (treatment week 1-9)]

Subjective Assessment Questionnaire (SAQ) [Time Frame: At 10 weeks]

Secondary ID(s)

Pilot child ICBT FGID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors