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

NCT ID: NCT06318572

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2025-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psychological intervention

Group Type: EXPERIMENTAL

Psychological intervention

Intervention Type: BEHAVIORAL

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI (Body Mass Index) between 18.5-24.99, with variations of up to 15%.
• Ability to understand instructions and follow protocol.
• Access to internet network from usual residence.

Exclusion Criteria

• Previous history of abdominal surgery with the exception of appendectomy and herniorrhaphy.
• Abuse of alcohol, tobacco or narcotics.
• Medical evidence of organic gastrointestinal pathology, hepatopathy, endocrinopathy, heart disease or contagious disease, as well as major psychiatric disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Jordi Serra, MD

Role: primary

jordi.serra@vallhebron.cat

34 932746259

Role: backup

jordi.serra@vallhebron.cat

Other Identifiers

PR(AG)166/2021

Identifier Type: -

Identifier Source: org_study_id