NCT06318572

Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders.

Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population. Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions. OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI. METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily. OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Psychological intervention	Patients will have 3 visits during the 7 weeks study length. On day -7 a first visit will be made verifying that inclusion criteria are met, the informed consent will be obtained and a rectal sensitivity test will be performed. A symptom questionnaire will be delivered to the patient for daily assessment of gastrointestinal symptoms. On day 0, a stool sample will be collected and the symptom questionnaire will be reviewed to confirm inclusion criteria. Patients will begin the program of psychological intervention. A first, session of psychoeducation will be performed, and thereafter sessions of psychotherapy will be performed at home during 6 weeks. At the end of treatment a last visit will be performed, collecting the symptoms scored during the last 7 days. A new stool sample will be collected and a rectal sensitivity study will be performed. Severity of symptom questionnaire will be filled at the beginning, after 3 weeks, at the end of the treatment, at 3 months and at 6 months.
BEHAVIORAL	Placebo	Patients will have 3 visits during the 7 weeks study length. On day -7 a first visit will be made verifying that inclusion criteria are met, the informed consent will be obtained and a rectal sensitivity test will be performed. A symptom questionnaire will be delivered to the patient for daily assessment of gastrointestinal symptoms. On day 0, a stool sample will be collected and the symptom questionnaire will be reviewed to confirm inclusion criteria. Patients will be instructed to take a capsule containing 0.5 g during 6 weeks. At the end of treatment a last visit will be performed, collecting the symptoms scored during the last 7 days, A new stool sample will be collected and a rectal sensitivity study will be performed. Severity of symptom questionnaire will be filled at the beginning, after 3 weeks, at the end of the treatment, at 3 months and at 6 months.

Timeline

• Start date: 2023-03-09
• Primary completion: 2024-12-30
• Completion: 2025-04-30
• First posted: 2024-03-19
• Last updated: 2024-03-19

Locations

1 site across 1 country: Spain