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Completed

NCT Number: NCT02113605

Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

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Key information

Conditions

Functional Gastrointestinal Disorders (FGID) Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases FGID According to the Rome III Criteria Functional Abdominal Pain Functional Dyspepsia Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Psychiatry in Stockholm

Stockholm, 11330, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 8-12 years
  • A diagnosis of a functional gastrointestinal disorder by a treating physician

Exclusion criteria

  • Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.
  • Psychiatric disorder more urgent to treat than the abdominal pain.
  • On-going psychological treatment.
  • Absence from school more than 40 %.
  • Ongoing maltreatment, violence or severe parental psychiatric illness.
  • Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Treatment and study plan

Cognitive Behavior Therapy

Other

Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

Primary outcomes

  1. Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks

    Time frame: Baseline and 10 weeks

  2. Change in Faces Pain Rating Scale (FACES) from baseline to 8 months.

    Time frame: Baseline and 8 months.

Secondary outcomes

  1. Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  2. Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks

    Time frame: Baseline and 10 weeks.

  3. Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks

    Time frame: Baseline and 10 weeks.

  4. Change in Functional Disability Index (FDI) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  5. Change in Pain Reactivity Scale from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  6. Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  7. Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  8. Change in Child Depression Inventory (CDI) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  9. Change in Pain Interference Index (PII) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  10. Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  11. Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months.

    Time frame: Baseline and 8 months

  12. Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months

    Time frame: Baseline and 8 months.

  13. Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  14. Change in Functional Disability Index (FDI) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  15. Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  16. Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  17. Change in Child Depression Inventory (CDI) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  18. Change in Pain Interference Index (PII) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  19. Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  20. Change in Pain Reactivity Scale from baseline to 8 months.

    Time frame: Baseline and 8 months.

Other outcomes

  1. Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  2. Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months.

    Time frame: Baseline and 8 months.

  3. Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks.

    Time frame: Baseline and 10 weeks.

  4. Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months.

    Time frame: Baseline and 8 months.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Exposure-Based CBT for Children With Functional Gastrointestinal Disorders - Development of a Protocol

Acronym: CBT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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