Irritable Bowel SyndromeEFINCT00788658
Cognitive Behaviour Therapy for Patients With IBS
A study testing Diet modifications and Cognitive behavioral therapy in people with Irritable Bowel Syndrome and Constipation, run by Rabin Medical Center.
Trial summary
Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation, Abdominal Pain
- What is being tested?
- Diet modifications and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- IBS
Who cannot join
- Malignancy
- Known psychiatric disorders
About this study
Official title: Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.
The aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.
The primary outcome measure was the score on a symptom-severity scale specific to IBS.
Read the detailed description
Symptomatic treatment of patients would not be modified
- Conditions
- Irritable Bowel Syndrome, Constipation, Abdominal Pain, Depression
- Being tested
- Diet modifications, Cognitive behavioral therapy
- Keywords
- Obstructed constipation, Quality of life
- Medical subject headings
- Irritable Bowel Syndrome, Constipation, Abdominal Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet modificationsBehavioural
Also called Diet
Diet consultation
Cognitive behavioral therapyBehavioural
Also called CBT
Cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Diet modifications | Placebo comparator | Diet consultation and life style modifications for 6 sessions Receives: Behavioral: Diet modifications |
| Cognitive therapy | Active comparator | 6 sessions of cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
Measured: 3 months
Secondary outcomes (1)
Quality of life assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Dickman, Rabin Medical Center
- Investigators
- Ram Dickman, MD, Principal investigator, RMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788658
- Sponsor's protocol ID
- RMC 5139
- Acronym
- EFI
- Status last verified
- Apr 2016
- First submitted
- 10 Nov 2008
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT00788658
- Acronym / sponsor ID
- EFI / RMC 5139
- Conditions
- Irritable Bowel Syndrome, Constipation, Abdominal Pain, Depression
- Keywords
- Obstructed constipation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Nov 2008 (estimated)
- 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.
Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.
The aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.
The primary outcome measure was the score on a symptom-severity scale specific to IBS.
Detailed description
Symptomatic treatment of patients would not be modified
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet modifications | Placebo comparator | Behavioral: Diet modificationsDiet consultation and life style modifications for 6 sessions |
| Cognitive therapy | Active comparator | Behavioral: Cognitive behavioral therapy6 sessions of cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75
- IBS
Key exclusion criteria (2 listed)
- Malignancy
- Known psychiatric disorders
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 |
|---|---|---|
| Diet modificationsAlso: DietDiet consultation | Behavioural | Diet modifications |
| Cognitive behavioral therapyAlso: CBTCognitive behavioral therapy | Behavioural | Cognitive therapy |
Primary outcome
Symptom score
Time frame: 3 months
1 secondary outcome
Quality of life assessment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
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.
Ram Dickman, MD principal investigator
RMC
Questions about this trial
What is this clinical trial studying?
A study testing Diet modifications and Cognitive behavioral therapy in people with Irritable Bowel Syndrome and Constipation, run by Rabin Medical Center.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom score (time frame: 3 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 13 Apr 2016.