Inflammatory Bowel DiseaseNCT01426568
A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease
A study testing Multi-Convergent Therapy in people with Inflammatory Bowel Disease, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Multi-Convergent Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to May 2013
- 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
- Diagnosis of Inflammatory Bowel Disease
- Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP <10
- Age 18 to 65 years
- Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score > 0.44)
Who cannot join
- Use of steroids within 1 month of entry to study
- Initiation or change in dose of medication within 1 month of entry to the study
- Presence of ileostomy or colostomy
- Diagnosis of dementia or cognitive impairment
- Current psychosis or substance misuse
- Change in psychotropic medication in 3 months prior to entry to study
- Previous psychological interventions
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff and Vale University Health Board
Cardiff, South Glamorgan, CF64 2XX
About this study
Official title: A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Multi-Convergent Therapy
- Keywords
- Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Convergent TherapyBehavioural
Also called Mindfulness Meditation
Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
| Study group | Role | What they receive |
|---|---|---|
| Course of Multi-Convergent Thearpy | Active comparator | Not described Receives: Behavioral: Multi-Convergent Therapy |
| Waiting List for Multi-Convergent Therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Measured: Assessed at baseline and at 4 months, 8 months, and 1 year
Secondary outcomes (6)
Change in Irritable Bowel Syndrome Symptom Severity Score
Measured: Assessed at baseline and at 4 months, 8 months, and 1 year
Change in Levenstein Perceived Stress Score
Measured: 2 monthly intervals over 1 year
Change in Hospital Anxiety and Depression Score
Measured: 2 monthly intervals over 1 year
Abdominal Symptoms Global Improvement Score
Measured: 4 monthly intervals over 1 year
Relapse rate in inflammatory bowel disease
Measured: 1 year
Feasibility of Treatment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426568
- Sponsor's protocol ID
- 10-CMC-4876
- Status last verified
- Aug 2013
- First submitted
- 26 Aug 2011
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Berrill JW, Sadlier M, Hood K, Green JT. Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. J Crohns Colitis. 2014 Sep;8(9):945-55. doi: 10.1016/j.crohns.2014.01.018. Epub 2014 Feb 13.
PubMed 24529603
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Multi-convergent Therapy for Inflammatory Bowel Disease Patients With Functional Abdominal Symptoms and High Perceived Stress
- ClinicalTrials.gov ID
- NCT01426568
- Acronym / sponsor ID
- 10-CMC-4876
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Multi-Convergent Therapy, Mindfulness Meditation, Functional Abdominal Symptoms, Irritable Bowel Syndrome, Inflammatory Bowel Disease, Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Aug 2011 (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.
The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Course of Multi-Convergent Thearpy | Active comparator | Behavioral: Multi-Convergent Therapy |
| Waiting List for Multi-Convergent Therapy | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Inflammatory Bowel Disease
- Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP <10
- Age 18 to 65 years
- Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score > 0.44)
Key exclusion criteria (8 listed)
- Use of steroids within 1 month of entry to study
- Initiation or change in dose of medication within 1 month of entry to the study
- Presence of ileostomy or colostomy
- Diagnosis of dementia or cognitive impairment
- Current psychosis or substance misuse
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 |
|---|---|---|
| Multi-Convergent TherapyAlso: Mindfulness MeditationCognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management | Behavioural | Course of Multi-Convergent Thearpy |
Primary outcome
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire
Time frame: Assessed at baseline and at 4 months, 8 months, and 1 year
6 secondary outcomes
Change in Irritable Bowel Syndrome Symptom Severity Score
Time frame: Assessed at baseline and at 4 months, 8 months, and 1 year
Change in Levenstein Perceived Stress Score
Time frame: 2 monthly intervals over 1 year
Change in Hospital Anxiety and Depression Score
Time frame: 2 monthly intervals over 1 year
Abdominal Symptoms Global Improvement Score
Time frame: 4 monthly intervals over 1 year
Relapse rate in inflammatory bowel disease
Time frame: 1 year
Feasibility of Treatment
Time frame: 4 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 30 Jan 2020.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 24529603Berrill JW, Sadlier M, Hood K, Green JT. Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. J Crohns Colitis. 2014 Sep;8(9):945-55. doi: 10.1016/j.crohns.2014.01.018. Epub 2014 Feb 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Convergent Therapy in people with Inflammatory Bowel Disease, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 4 inclusion and 8 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 30 Jan 2020. 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 United Kingdom. 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. 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?
Change in Quality of Life in Inflammatory Bowel Disease Questionnaire (time frame: Assessed at baseline and at 4 months, 8 months, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426568, which also lists 2 linked publications.
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 30 Jan 2020.