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
ms84/@stir.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Mariyana Schoultz
ORCID ID
Contact details
University of Stirling (Highland Campus)
School of Nursing
Midwifery and Health
Centre For Health Science
Old Perth Road
Inverness
Inverness
IV2 3JH
United Kingdom
01463255647
ms84@stir.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
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
Condition
Inflammatory bowel disease
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
01/05/2013
Overall trial end date
01/05/2015
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
40
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
01/05/2013
Recruitment end date
01/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Stirling (Highland Campus)
Inverness
IV2 3JH
United Kingdom
Sponsor information
Organisation
University of Stirling (UK)
Sponsor details
3B1 Cottrell Building
Stirling
FK9 4LA
United Kingdom
-
carol.johnstone@stir.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Stirling (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
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
Associations and societies (private and public)
Location
United Kingdom
Funder name
R&D Highland (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24341333
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26303912
Publication citations
-
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.
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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.