Hypnotherapy With Audiofiles for Children and Adolescents With Disorders of Gut-brain Interactions in Sweden -a Feasibility Study
NCT Number: NCT06493097
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-hypnosis|Functional Bowel Disorder|Functional Abdominal Pain Syndrome
Interventions: BEHAVIORAL: Gut-directed hypnotherapy via audio files
Sponsor: Karolinska Institutet
Collaborators: Region Stockholm
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2024-10
Locations: Karolinska Institutet, Stockholm, 113 26, Sweden

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. 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. 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. 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.

Primary Outcome Measures: Peds-QL-gastro, Short questionnaire gastrointestinal symptom scale. Minimum value 0, maximum value 100, higher score means better outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.
Secondary Outcome Measures: Pain frequency and intensity, FACES pain scale. Minimum value 0, maximum value 10, higher score means worse outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.|Stress, PAS pediatric stress questionnare. Minimum value 0, maximum value 44, higher score means worse outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.|Gastrointestinal symtom -related anxiety, BRQ-C questionnare. Minimum value 11, maximum value 77, higher score means worse outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.|GI symptom specific anxiety, Visceral sensitivity index short scale. Minimum value 0, maximum value 35, higher score means worse outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.|Quality of life, Peds-QL- QOL. Minimum value 0, maximum value 100, higher score means better outcome., Week 0 (pre), 3, 6, 9 and 12 (post) of treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.|Adequate relief, SAQ. Minimum value 0, maximum value 7, higher score means better outcome., Week 12 (post) treatment. The post-treatment measurement must be finished within 2 weeks from end of treatment.