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OpenTrials
Completed

NCT Number: NCT03252743

ICBT for Pain-predominant FGIDs 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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Exposure-based internet-delivered CBT

Behavioral

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.

Primary outcomes

  1. Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

    Time frame: Baseline to 10 weeks.

    Change in global gastrointestinal symptoms from baseline to 10 weeks.

Secondary outcomes

  1. Pain intensity (Faces Pain rating scale)

    Time frame: Baseline to 10 weeks

    Change in pain intensity from baseline to 10 weeks

  2. Pain intensity (Faces Pain rating scale)

    Time frame: Baseline to 5 months.

    Change in pain intensity from baseline to 3 months follow-up.

  3. Pain intensity (Faces Pain rating scale)

    Time frame: Baseline to 8 months.

    Change in pain intensity from baseline to 6 months follow-up.

  4. Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

    Time frame: Baseline to 5 months.

    Change in global gastrointestinal symptoms from baseline to 3 months follow-up.

  5. Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

    Time frame: Baseline to 8 months.

    Change in global gastrointestinal symptoms from baseline to 6 months follow-up.

  6. Gastrointestinal symptoms module (PedsQL Gastro)

    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.

  7. Gastrointestinal symptoms module (PedsQL Gastro)

    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.

  8. Gastrointestinal symptoms module (PedsQL Gastro)

    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.

  9. Fear for symptoms (Visceral sensitivity index)

    Time frame: Baseline to 10 weeks.

    Change in fear for symptoms from baseline to 10 weeks.

  10. Fear for symptoms (Visceral sensitivity index)

    Time frame: Baseline to 5 months.

    Change in fear for symptoms from baseline to 3 months follow-up.

  11. Fear for symptoms (Visceral sensitivity index)

    Time frame: Baseline to 8 months.

    Change in fear for symptoms from baseline to 6 months follow-up.

  12. Avoidant behavior (IBS-BRQ)

    Time frame: Baseline to 10 weeks

    Change in avoidant behavior from baseline to 10 weeks.

  13. Avoidant behavior (IBS-BRQ)

    Time frame: Baseline to 5 months.

    Change in avoidant behavior from baseline to 3 months follow-up.

  14. Avoidant behavior (IBS-BRQ)

    Time frame: Baseline to 8 months.

    Change in avoidant behavior from baseline to 6 months follow-up.

  15. Quality of life (PedsQL)

    Time frame: Baseline to 10 weeks.

    Change in quality of life from baseline to 10 weeks.

  16. Quality of life (PedsQL)

    Time frame: Baseline to 5 months.

    Change in quality of life from baseline to 3 months follow-up.

  17. Quality of life (PedsQL)

    Time frame: Baseline to 8 months.

    Change in quality of life from baseline to 6 months follow-up.

Other outcomes

  1. Parental responses to children´s symptom behavior (ARCS)

    Time frame: Baseline to 10 weeks.

    Change in parental responses from baseline to 10 weeks.

  2. Parental responses to children´s symptom behavior (ARCS)

    Time frame: Baseline to 5 months.

    Change in parental responses from baseline to 3 months follow-up.

  3. Parental responses to children´s symptom behavior (ARCS)

    Time frame: Baseline to 8 months.

    Change in parental responses from baseline to 6 months follow-up.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2017
Registry last updated
Feb 26, 2019

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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