Can mindfulness-based cognitive therapy (a group self-help program) improve the quality of life for inflammatory bowel disease patients?
| ISRCTN | ISRCTN27934462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27934462 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/08/2013
- Registration date
- 09/08/2013
- Last edited
- 26/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
University of Stirling (Highland Campus)
School of Nursing, Midwifery and Health
Centre For Health Science
Old Perth Road
Inverness
Inverness
IV2 3JH
United Kingdom
| Phone | 01463255647 |
|---|---|
| ms84@stir.ac.uk |
Study information
| Study design | Exploratory randomised controlled trial with embedded process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | NRES Committee for North of Scotland, 08/04/2013. REC ref: 13/NF/0018 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2013 |
| Completion date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2013 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
IV2 3JH
United Kingdom
Sponsor information
University/education
3B1 Cottrell Building
Stirling
FK9 4LA
Scotland
United Kingdom
| carol.johnstone@stir.ac.uk | |
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Crohn's & Colitis UK
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/12/2013 | Yes | No | |
| Results article | results | 25/08/2015 | Yes | No |
