Condition category
Digestive System
Date applied
04/02/2019
Date assigned
12/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.ucl.ac.uk/jro

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

Publication citations

Additional files

Editorial Notes

21/02/2019: Trial's existence confirmed by NHS Health Research Authority and CICRA.