Efficacy of a mindfulness-based intervention for spinal cord injured outpatients with chronic neuropathic pain

Plain English summary of protocol

Background and study aims:
Millions of people suffer from chronic pain. Living with chronic pain causes the sufferer both physical and mental strain and they can often feel frustrated, angry and/or depressed. Pain killing medications may help ease the physical discomfort but can cause unpleasant side effects. Recently, mindfulness-based techniques have been attracting interest, having been shown to reduce symptoms and help people cope better with their condition. Further research into this area is therefore important. Mindfulness differs from cognitive-behavioural approaches, in that it does not aim to change or alter thoughts or the ways that a patient responds to pain. Mindfulness encourages active acceptance of the experience as it is, by observing pain in a non-analytical way and without judgement. Web-based mindfulness interventions (programmes) are growing in use, and may be ideal for use with those with spinal cord injuries (SCI) who may find getting to face-to-face meetings difficult due to mobility issues. No previous work has explored whether mindfulness can help people with SCI. Here, we want to test a web-based mindfulness intervention for people with SCI and chronic pain, alongside their partners or primary care-givers, in order to assess the effects of the intervention on their quality of life, experience of pain, and social relationships and understanding.

Who can participate?
Outpatients from the National Spinal Injuries Centre, Stoke Mandeville Hospital (UK) database who are suffering with chronic neuropathic pain. They must be at least 18 years of age.

What does the study involve?
Participants (SCI patients and their partners) are randomly allocated into one of two groups. Those in group 1 (control group) are asked to complete questionnaires regarding quality of life,
depression, anxiety, pain-related outcomes, and social relationship measures, at the start of the trial, then at four weeks, eight weeks, and 20 weeks into the trial. Those in group 2 (mindfulness group) are registered onto an eight-week online mindfulness course, and must have internet access for the full eight weeks. The course involves doing mindfulness exercises for ten minutes twice a day. Like the participants in the control group, they complete questionnaires regarding quality of life,
depression, anxiety, pain-related outcomes, and social relationship measures, at the start of the trial, then at four weeks, eight weeks, and 20 weeks into the trial. The data is analysed using statistics, and will contribute to the literature base surrounding mindfulness. If positive results of the intervention are found, participants may continue to be involved in the research in order to explore the data further.

What are the possible benefits and risks to taking part in this study?
There will be no risk of physical harm to participants. It is possible, however, that engaging in mindfulness may cause some distress. The mindfulness course will ask participants to engage with their body and acknowledge any feelings that may or may not be present. It may be possible that distress may occur at the beginning of this course, as participants become accustomed to mindfulness, particularly for those who have had difficult times managing their pain. However, as they engage with their body more, the benefits are likely to far outweigh the risks. Participants will be allowed to pause or stop mindfulness exercises should they need to. Weekly motivational emails will be sent to the group, and participants will be welcome to contact the researchers and the company providing the online course, should they desire. They may also withdraw from the study and have their data destroyed should they so wish. Data will be stored in a password-protected computer database on the psychology department server at The University of Buckingham. Only those directly involved in the research will have access to this information.

Where is the study run from?
The study has been set up by The University of Buckingham, in collaboration with the National
Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury (UK).

When is the study starting and how long is it expected to run for?
January 2015 to August 2015

Who is funding the study?
PhD scholarship from the University of Buckingham (UK).

Who is the main contact?
Jasmine Hearn, Principal Investigator, jasmine.hearn@buckingham.ac.uk
Katherine Finlay, Chief Investigator, katherine.finlay@buckingham.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

The University of Buckingham
University/education

The Psychology Department
Hunter Street
Buckingham
MK18 1EG
England
United Kingdom

Email	alan.martin@buckingham.ac.uk
Website	http://www.buckingham.ac.uk
"ROR"	https://ror.org/03kd28f18

Funders

Funder type

University/education

Results and Publications

Study outputs

Editorial Notes

14/02/2018: Publication reference added.