Irritable Bowel SyndromeNCT06318572
Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders.
A study testing Psychological intervention in people with Irritable Bowel Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Psychological intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Jordi Serra, MD, 34 932746259, jordi.serra@vallhebron.cat
jordi.serra@vallhebron.cat
About this study
Official title: Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.
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.
Read more
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
- Being tested
- Psychological intervention, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological interventionBehavioural
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.
PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychological intervention | Experimental | Not described Receives: Behavioral: Psychological intervention |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of abdominal symptoms
Changes from basal scores in the severity of abdominal symptoms will be calculated using the irritable bowel syndrome-symptom severity score (IBS-SSS), where score 0 is the lack of symptoms, and score 500 is maximal severity of symptoms.
Measured: 6 months
Secondary outcomes (6)
IBS related Quality of life
Changes from basal scores in the IBS related quality of life will be calculated using the irritable Bowel Syndrome Quality of Life Questionnaires (IBS-QoL). Rated from 0-100 % (worst-best quality of life).
Measured: 6 weeks
Stress
Changes from basal scores in the patients perceived stress will be calculated using the perceived stress scale (PSS). Score range 0 (no stress-40 highest perceived stress).
Measured: 6 weeks
Anxiety and depression
Changes from basal scores in the anxiety and depression rated by patients will be calculated using the hospital anxiety and depression scale (HAD). Score range 0 (no anxiety/depression-21 highest anxiety and depression in the respective scales).
Measured: 6 weeks
Somatic co-morbidities
Changes from basal scores in the somatic co-morbidities will be calculated using the personal health questionnaire (PHQ-15). Score range 0 (no somatization-30 highest somatization).
Measured: 6 weeks
Rectal sensitivity
Changes from basal scores in the sensitivity induced by progressive rectal distension applied by means of a barostat, will be calculated using a 0 (no perception)-6 (painful sensation) score scale.
Measured: 6 weeks
Analysis of gut microbiota composition
Changes from basal scores in the alfa and beta diversity and relative abundance of gut microbes will be calculated using 16S rRNA bacterial metagenomic sequencing.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start9 Mar 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318572
- Sponsor's protocol ID
- PR(AG)166/2021
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desarrollo de Programas de intervención psicológica Autoadministrable Con Soporte de Nuevas tecnologías Como Tratamiento Para Pacientes Con Trastornos Funcionales Digestivos.
- ClinicalTrials.gov ID
- NCT06318572
- Acronym / sponsor ID
- PR(AG)166/2021
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological intervention | Experimental | Behavioral: Psychological intervention |
| Placebo | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological interventionPatients 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. | Behavioural | Psychological intervention |
| PlaceboPatients 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. | Behavioural | Placebo |
Primary outcome
Severity of abdominal symptoms
Time frame: 6 months
Changes from basal scores in the severity of abdominal symptoms will be calculated using the irritable bowel syndrome-symptom severity score (IBS-SSS), where score 0 is the lack of symptoms, and score 500 is maximal severity of symptoms.
6 secondary outcomes
IBS related Quality of life
Time frame: 6 weeks
Stress
Time frame: 6 weeks
Anxiety and depression
Time frame: 6 weeks
Somatic co-morbidities
Time frame: 6 weeks
Rectal sensitivity
Time frame: 6 weeks
Analysis of gut microbiota composition
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention in people with Irritable Bowel Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of abdominal symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.