Hypnotherapy With Audiofiles for Children and Adolescents With Disorders of Gut-brain Interactions in Sweden -a Feasibility Study

NCT06493097 | Completed Results DMC

• 1 other identifier: 2023-00296-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at testing the effect and feasibility of a new treatment strategy - hypnotherapy mediated with audio files - for children and adolescents with disorders of gut-brain-interaction (DGBI) in Sweden. The treatment protocol has been used and studied in Netherlands, but the investigators have translated and formed it to suit the Swedish population. This study is a feasibility study that is followed by a large RCT to compare different psychological treatment options for this patient group. If hypnotherapy mediated via audio files proves to be effective and feasible for this patient group, it would mean:

1. 1.An exponential increase in the availability of evidence-based treatments. The hypnotherapy treatment is markedly easier to distribute than e.g. cognitive behavior therapy (CBT) which requires chat contact with a psychologist and is made available regardless of where in Sweden the family lives. In addition to shortened waiting times for patients, this would decrease the pressure in somatic care.
2. 2.Possibility to offer tailored treatments. No treatment works for everyone. It is reasonable to assume that treatments with such different focuses as hypnotherapy and exposure-based CBT may be differently effective for different patients. A new treatment option can help a larger proportion of patients.
3. 3.A more cost-effective treatment. Gut-directed hypnotherapy with audio files is a very inexpensive treatment, which would likely result in significant cost savings for this patient population.

Conditions

Self-hypnosis; Functional Bowel Disorder; Functional Abdominal Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Peds-QL-gastro

  Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome.

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

Secondary Outcomes (6)

• Pain Frequency and Intensity

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

• Stress

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

• Gastrointestinal Symtom -Related Anxiety

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

• GI Symptom Specific Anxiety

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

• Quality of Life

  Week 0 (pre) and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.

Study Arms (1)

Treatment with hypnotherapy audio files

EXPERIMENTAL

Participants get access to a website, where they can find information about the diagnosis DGBI and mechanisms leading to symtoms. On the website they also get access to a tretament protocoll for self-hypnosis with audio files (5 different audio files, age-adjusted). Participants listen to audio files min 5 times/week for 12 weeks. They answer the study questionnaries before, after and every 3 weeks during the treatment.

Behavioral: Gut-directed hypnotherapy via audio files

Interventions

Gut-directed hypnotherapy via audio files BEHAVIORAL

5 audio files 10-15 min each, min 5 times a week for 12 weeks

Treatment with hypnotherapy audio files

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis: irritable bowel syndrome, functional abdominal pain, functional dyspepsia (following the Rome IV diagnostic criteria)
• The participant and at least one of the parents must understand Swedish

You may not qualify if:

• other medical condition that better explains the symtoms
• Absence from school \>40% and/or psychiatric diagnosis that is judged to be more primary than the gastrointestinal problems, in these cases the children/young people are judged to need more intensive and multi-professional treatment

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 113 26, Sweden

Location

Limitations and Caveats

The within-group study design is a limitation, as true efficacy cannot be assessed while regression toward the mean cannot be controlled for. Another limitation was the lack of reliable compliance reporting.

Results Point of Contact

• Title: Tea Soini
• Organization: Karolinska Institutet

tea.soini@ki.se

046-766457611

Study Officials

• Ola Olén, MD PhD prof

  Department of clinical epidemiology, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, senior consultant i pediatric gastroenterology

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 9, 2024
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)