Plain English Summary
Background and study aims
Inflammatory bowel disease (IBD), namely Crohn’s disease (CD) and ulcerative colitis (UC), is a complex inflammatory disease accompanied by pain and distress. 1 in every 250 people in the UK has IBD, which means there are about 240,000 patients in the UK. The incidence of IBD in young people is increasing, with one in four new cases now diagnosed under the age of 16. Adolescence is a time of great physical, social and emotional change and having IBD during this time can be devastating.
Flare-ups of IBD can happen during times of stress, so finding ways of helping people with IBD manage stress is essential. Mindfulness-Based Stress Reduction (MBSR) is the most well-recognised approach for the management of stress and long-lasting illness. It consists of an 8-week group programme, in which participants are taught about the relationship between stress and illness and trained in mindfulness meditation practices. A number of studies have shown that MBSR may be useful in people with IBD. Research in adults has shown that MBSR helped to reduce flare-ups in people with high levels of stress and also it improved quality of life in those who did experience flare-ups. There needs to be more research investigating MBSR in adolescents and young adults.
This study aims to investigate whether taking part in an 8-week MBSR group programme can improve symptoms (e.g. pain and flare-ups) and quality of life in young people who have IBD. In this course, participants will be taught a range of techniques that have been shown to help people manage the stress associated with pain and physical symptoms and promote emotional well-being.
Who can participate?
People aged between 15 and 24 who have a diagnosis of Crohn’s disease or ulcerative colitis (two types of IBD) can participate in this study.
What does the study involve?
This is a waiting list control trial. This means that participants will be randomly assigned to one of two groups. Group 1 will start the course immediately after recruitment and Group 2 will participate in the programme about 8 to 10 weeks later. The course itself will be the same for both groups.
Group 1:
• A member of the research team will questions about physical symptoms, stress and emotional well-being. Patients who are interested in the research will then be asked to complete a consent form and some questionnaires. The researcher will also ask for consent to view the participant's medical information, including blood test results. This will take place during the usual gastroenterology outpatient clinic appointment.
• People allocated to Group 1 will then be invited to attend the 8-week course (one session per week for 1.5 hours), which will be delivered in a group format with other young people.
• Once the course has finished, participants will be asked again about physical symptoms, stress and emotional well-being again . Once again this will take place at the usual gastroenterology outpatient clinic appointment.
• The above assessments will be repeated again 10-12 weeks later at the next outpatient appointment.
Group 2:
• A member of the research team will ask questions about physical symptoms, stress and emotional well-being. People who are interested in the research will then be asked to complete a consent form and some questionnaires. The researcher will also ask for consent to view the participant's medical information including blood test results. This will take place during the usual gastroenterology outpatient clinic appointment.
• The above assessments will be repeated 10-12 weeks later at the next outpatient appointment, before the 8-week course begins.
• Participants will then be invited to attend the 8-week course which will be delivered in a group format with other young people. This will begin approximately 2 months later than Group 1. The content of the course will be the same as Group 1.
• Once the course has finished, participants will be asked again about physical symptoms, stress and emotional well-being, again at the next gastroenterology outpatient appointment.
What are the possible benefits and risks of participating?
The programme aims to reduce stress, reduce symptoms associated with Crohn’s disease and ulcerative colitis and improve overall emotional well-being and quality of life. There are unlikely to be any risks involved in taking part in the research. The group sessions are led by an experienced clinical psychologist who will be available to meet with anyone should they experience any difficulties and give advice about what to do.
Where is the study run from?
University College London Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2015 to December 2018
Who is funding the study?
Crohn’s in Childhood Research Association (CICRA)
Who is the main contact?
1. Dr Jacqueline Doyle, Clinical Psychologist
Jacqueline.doyle3@nhs.net
2. Prof. Deborah Christie
deborah.christie2@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Prof Deborah Christie
ORCID ID
Contact details
Child and Adolescent Psychological Medicine
Level 6
250 Euston Road
London
NW1 2PG
United Kingdom
0203 447 9086
deborah.christie2@nhs.net
Type
Scientific
Additional contact
Dr Jacqueline Doyle
ORCID ID
Contact details
GI Division
Ground Floor West
250 Euston Road
London
NW1 2PG
United Kingdom
0203 447 9419
jacqueline.doyle3@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 207335, protocol 16/503
Study information
Scientific title
An evaluation of mindfulness-based stress reduction groups for adolescents and young adults with Crohn’s disease and ulcerative colitis
Acronym
MBSR-AH
Study hypothesis
1. A mindfulness-based psychological intervention can improve inflammatory-related symptoms in adolescents with inflammatory bowel disease (IBD) rated by by self-reported symptom measures.
2. Psychological stress correlates with the activation of cellular immune and inflammatory responses.
Ethics approval
Approved 02/03/2017, Yorkshire and The Humber Bradford Leeds Research Ethics Committee of the Health Research Authority (nrescommittee.yorkandhumber-bradfordleeds@nhs.net, 0207 104 8088), ref: 17/YH/0050
Study design
Randomised waiting-list-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use contact details to request an information sheet.
Condition
Inflammatory bowel disease
Intervention
Participants will be randomly assigned to one of two groups. Group 1 will start the MBSR course immediately after recruitment and Group 2 will participate in the programme about 8 to 10 weeks later. The course itself will be the same for both groups. The process for each group is outlined below:
1. Group 1:
1.1. A member of the research team will ask questions about any gastro-intestinal symptoms and about current emotional well-being. People who are eligible for the research will be asked to complete a consent form and some additional questionnaires. This will all take place during the routine outpatient gastroenterology appointment.
1.2. Participants will then be invited to attend an 8-week Mindfulness-Based Stress-Reduction (MBSR) course (one session per week for 1.5 hours), which will be delivered in a group format with other young people. In this course people will be taught a range of mindfulness practices that have been shown to help people manage the stress associated with pain and physical symptoms and promote emotional well-being. In addition to this participants will be given a CD of a variety of different mindfulness practices and asked to do these at home for approximately 20 minutes each day.
1.3. After the group sessions have ended, participants will be asked the questions about gastrointestinal symptoms, stress and well-being again at the next gastroenterology outpatient appointment. These assessments will be repeated again 10-12 weeks later at the next outpatient appointment.
2. Group 2:
2.1. A member of the research team will ask questions about any gastrointestinal symptoms and about current emotional well-being. People who are eligible for the research will be asked to complete a consent form and some additional questionnaires. This will all take place during the routine outpatient gastroenterology appointment. These assessments will be repeated 10-12 weeks later at the next outpatient appointment, before the Mindfulness Based Stress Reduction (MBSR) course has started.
2.2. Participants will then be invited to attend an 8-week MBSR course which will be delivered in a group format with other young people. This will begin approximately 2 months later than Group One. The content of the course will be the same as in Group 1.
2.3.Finally, after the group sessions have ended, group 2 will be asked the questions about gastrointestinal symptoms, stress and well-being again at the next gastroenterology outpatient appointment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
For CD patients:
1. Patient-reported symptoms assessed using the Harvey-Bradshaw Index (HBI) at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
For UC patients:
2. Patient-reported symptoms assessed using the Paediatric Ulcerative Colitis Activity Index (PUCAI) at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
3. Patient-reported symptoms assessed using the Simple Clinical Colitis Activity Index (SCCAI) at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
For all patients:
4. Haematological parameters, including full blood count and erythrocyte sedimentation rate, assessed before and after the intervention
5. C-reactive protein (CRP, a marker of inflammation) level in blood assessed before and after the intervention
6. Intestinal inflammation assessed using faecal calprotectin level before and after the intervention
Secondary outcome measures
1. Health-related quality of life specific to IBD assessed using the IMPACT-III Quality of Life Questionnaire at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
2. Mindfulness assessed using the Mindful Attention Awareness Scale at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
3. Mental wellbeing assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
4. Perception of stress assessed using the Perceived Stress Scale (PSS) at T0 (at recruitment), T1 (10 -12 weeks after recruitment) and T2 (10-12 weeks after T1)
Overall trial start date
19/03/2016
Overall trial end date
25/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 15-24 years
2. Diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC)
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
86
Total final enrolment
58
Participant exclusion criteria
1. Severe IBD
2. Currently experiencing severe psychological difficulties (e.g. psychosis, substance abuse or suicidality)
Recruitment start date
21/03/2017
Recruitment end date
26/06/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospitals
GI Division
Ground Floor West
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor information
Organisation
University College London Hospitals
Sponsor details
Joint Research Office
UCL
Gower St
London
WC1E 6BT
United Kingdom
+44 (0) 20 3447 5199
randd@uclh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Crohn’s in Childhood Research Association
Alternative name(s)
CICRA
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The data is currently being analysed and will be published in a high-impact peer-reviewed journal in approximately October 2019.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/10/2019
Participant level data
Other
Basic results (scientific)
Publication list