Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Inflammatory bowel disease (IBD) is an incurable long-term condition affecting 250,000 sufferers in the UK and 28 million people worldwide. The disease affects the gut and the two main types are Crohn's disease and ulcerative colitis. The IBD disease course is highly unpredictable and symptoms include pain (due to inflammation of the gut), diarrhoea, vomiting and other symptoms that cause great distress for the individual. Rates of anxiety and depression among people with IBD are higher than the general population. Previous studies suggested that experiencing the prolonged effects of pain, anxiety, distress and low mood could have a harmful effect on quality of life. Mindfulness-based cognitive therapy (MBCT) is a psychological group programme based on the concept that the participants of an eight-week MBCT course will experience reduced negative effects from pain and psychological factors such as distress, anxiety and low mood at completion of the course. In this study, we are aiming to test the group MBCT programme for IBD patients and collect information that will inform a future full-scale study.

Who can participate?
All adults aged 18 or over with a confirmed diagnosis of Crohn's disease or ulcerative colitis.

What does the study involve?
Participants will be randomly allocated to one of two groups. Both groups will go through the same MBCT programme, but the second group will start approximately six months later than the first group (after the six months follow-up data has been collected). This will allow comparison between the two groups in the six months. The second group will be given a leaflet 'Staying Well with IBD' as soon as they are randomly allocated and informed that they are in the second group. Both groups will be asked to complete questionnaires at the start of the study, at two months and at six months and will be invited to a group chat.

What are the possible benefits and risks of participating?
We believe that going through the MBCT programme, IBD patients will become empowered with non-drug-related strategies and tools to reduce daily stress, anxiety and low mood which could help improve their quality of life. This could potentially benefit all Crohn's and colitis patients who are enrolling, but also can benefit any future patients diagnosed with IBD. No side effects are known.

Where is the study run from?
The study has been set up by University of Stirling in collaboration with NHS Highland and NHS Grampian, UK.

When is the study starting and how long is it expected to run for?
Recruitment of the study started in May 2013 and the completion of the study is anticipated for the end of 2015. Participants will be recruited for up to a year.

Who is funding the study?
University of Stirling, UK.

Who is the main contact?
Ms Mariyana Schoultz

Trial website

Contact information



Primary contact

Ms Mariyana Schoultz


Contact details

University of Stirling (Highland Campus)
School of Nursing
Midwifery and Health
Centre For Health Science
Old Perth Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: a pilot randomised controlled trial with embedded process evaluation


Study hypothesis

The aim of the study is to pilot a group mindfulness-based cognitive therapy program in inflammatory bowel disease patients.
The study objectives are:
1. To adapt an intervention manual based on MBCT manual developed by Segal et al (Segal et al, 2013), outlining how to carry out an MBCT program for IBD patients.
2. To determine the feasibility of conducting a definitive RCT of group MBCT for improvement of quality of life for IBD patients.
3. To use data arising from differences between MBCT and control arm to inform a power calculation for sample size of a definitive RCT.
4. Estimate trial recruitment (percentage of IBD patients who consent to the trial) and completion/retention rates (percentage of participants completing the trial).
5. To embed a process evaluation within the pilot trial to assess the acceptability of the intervention and trial procedures for IBD patients :
5.1. Assess acceptability of recruitment, randomisation and consent procedure
5.2. Assess acceptability and feasibility of collecting reliable and valid data on primary and secondary outcomes
5.3. Assess the fidelity of protocol
5.4. Assess acceptability of length of intervention
5.5. Assess appropriateness/suitability of the intervention used
5.6. Assess barriers to attendance
5.7. Assess expectations about intervention
5.8. Assess perceived impact on quality of life

On 13/11/2013 the sources of funding field was updated; the previous source of funding was University of Stirling (UK).

Ethics approval

NRES Committee for North of Scotland, 08/04/2013. REC ref: 13/NF/0018

Study design

Exploratory randomised controlled trial with embedded process evaluation

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Inflammatory bowel disease


There are two arms to this study: an active intervention group (8-week mindfulness-based cognitive therapy group) and a waiting list control group

The mindfulness-based cognitive therapy involves eight weekly sessions, each one lasting for approximately 120 minutes. The sessions are led by mindfulness facilitators (professionals delivering mindfulness groups with different patient groups within the NHS, who have attended an initial 8-week mindfulness based cognitive therapy program, a further mindfulness teacher training course and who receive regular supervision). The intervention is manualised to ensure consistency across the different venues where it is being delivered.
Mindfulness-based cognitive therapy (MBCT) is a psychological group intervention based on the concept that the participants of an eight week MBCT course will experience reduced negative effects from pain and psychological factors such as distress, anxiety and depression at completion of the 8-week course.

Those participants allocated to the waiting list control arm of the study will have an opportunity to receive the same MBCT program after six months, once the follow up data has been collected.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Quality of life - IBDQ inflammatory bowel disease specific quality of life questionnaire at baseline, two months and six months follow up.

Secondary outcome measures

1. Anxiety - state and trait anxiety (STAI)
2. Depression - Becks depression inventory (BDI)
3. Disease activity - Crohn's disease activity Index - (CDAI) or Simple clinical colitis activity index (SCCAI)
4. Attention Awareness - Mindful attention awareness scale (MAAS)
All assessed at baseline, two months and six months follow up
Evaluation Survey at two months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Be able to verbally communicate and write in English (English language does not have to be first language)
2. Able to give informed consent
3. Age of 18 or over (no upper limit)
4. Confirmed diagnosis of Crohn's disease or Ulcerative Colitis (by clinician)
5. Ability to do light exercise (for example to lift arms above the head or bend knees)
6. To be able to commit to at least 6 sessions out of 8
7. To be able to commit to do home practice of up to 45 minutes daily over the 8 weeks of the study
8. No change of antidepressants (dose or type) within the last three months

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unable to give informed consent
2. Major psychiatric illness
3. Active alcohol or drug dependency
4. Scheduled for major surgery in the next three months
5. Participation in pharmacological study or psychological intervention study within the last six months or intention to participate in pharmacological study during the duration of this study
6. Have recently (within the last three months) been prescribed antidepressants
7. With exacerbated symptoms

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Stirling (Highland Campus)
United Kingdom

Sponsor information


University of Stirling (UK)

Sponsor details

3B1 Cottrell Building
United Kingdom

Sponsor type




Funder type


Funder name

University of Stirling (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Funder name

Crohn's and Colitis UK

Alternative name(s)

Crohn's & Colitis UK

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies


United Kingdom

Funder name

R&D Highland (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in:
2015 results in:

Publication citations

  1. Protocol

    Schoultz M, Atherton IM, Hubbard G, Watson AJ, The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation., Trials, 2013, 14, 431, doi: 10.1186/1745-6215-14-431.

  2. Results

    Schoultz M, Atherton I, Watson A, Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial, Trials, 2015, 16, 1, 379, doi: 10.1186/s13063-015-0909-5.

Additional files

Editorial Notes