An evaluation of an online mindfulness programme for people with multiple sclerosis

• Register: ISRCTN
• Last refreshed on: 10 December 2018
• Main ID: ISRCTN14675178
• Date of registration: 07/03/2018
• Prospective Registration: Yes
• Primary sponsor: Irish Health Research Board and the Medical Research Charities Group Joint Funding Scheme
• Public title: An evaluation of an online mindfulness programme for people with multiple sclerosis
• Scientific title: Comparing the clinical- and cost-effectiveness of an internet-delivered mindfulness-based program with waitlist controls among adults with progressive MS
• Date of first enrolment: 01/06/2018
• Target sample size: 128
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN14675178
• Study type: Interventional
• Study design: The design is a single-blind randomised controlled trial comparing the effects of an internet-delivered mindfulness training intervention with a waitlist control condition for people living with MS. Participants will be assessed at three time points: baseline, post-intervention and 3-month follow up. Any modifications to the protocol which may impact on the conduct of the study will require a formal amendment to the protocol. Such amendment will be agreed on by the Irish Health Research Board and the Medical Research Charities Group Joint Funding Scheme (MRCG-MSIreland/HRB-14-07-16) research group and approved by the relevant ethics committee prior to the implementation of the modifications. Minor administrative changes to the protocol will be agreed on by the Irish Health Research Board and the Medical Research Charities Group Joint Funding Scheme (MRCG-MSIreland/HRB-14-07-16) research group and will be documented in a memorandum (Treatment)

Countries of recruitment

Ireland

Contacts

• Name: Chris Dwyer

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years or more
2. Diagnosis of primary or secondary progressive MS
3. Internet access
4. Not currently undergoing any form of psychological treatment
5. First language English
6. Resident in Ireland, not currently experiencing a psychotic illness and/or cognitive impairment.

Exclusion criteria:
1. Participants undergoing any form of psychological treatment
2. Participants experiencing a psychotic illness and/or cognitive impairment
3. Participation in any other form of psychological intervention in addition to the study intervention is prohibited during the trial


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis (MS) is a chronic, lifelong disease of the nervous system characterised by demyelination of the nerve cells in the central nervous system. Demyelination is irreparable and can occur anywhere in the nervous system; thus, it is associated with any number of symptoms, depending on where the damage is located (Mohr & Cox, 2001). The cause of MS is currently unknown and there is no cure. Approximately 2.3 million people are diagnosed with MS worldwide (National Multiple Sclerosis Society, 2012), with diagnosis twice as common in women as men. MS typically manifests between the ages of 20 and 40, with a sudden onset of symptoms - sometimes with large gaps of remission, while other cases are characterised by continuous deterioration. Symptoms can vary from mild sensational problems (e.g. tingling) to severe disability. However, due to the often physiologically disabling nature of the illness, MS has long been associated with poorer wellbeing and characterised by a number of psychological impacts. For example, the stressful nature of MS symptoms has been linked with depression (Matson & Brooks, 1977), affecting up to 50% of people living with MS in their lifetime (Feinstein, 2011). Furthermore, psychological issues could be responsible for further relapses and exacerbations of symptoms (Ackerman et al., 2002).
Nervous System Diseases
Multiple Sclerosis (MS)

Intervention(s)

The intervention consists of eight online, mindfulness-based sessions over an 8-week period. The content of the mindfulness sessions have been developed specifically for people living with MS and qualitative data obtained from participative health research workshops with MS patients and MS-specialist nurses (conducted by our Centre for Pain Research) for online delivery.

The focus of the therapy is mindfulness-based distress reduction with the addition of cognitive therapy exercises (e.g. exploring individual thoughts regarding MS and how these thoughts relate to anxiety and low mood); and the programme consists of information, in-session activities, relevant mindfulness metaphors and mindfulness exercises. The MindfulnessforMS intervention has been developed into an online format by a postdoctoral psychologist who has expertise in both the mindfulness approach and developing online psychological treatment interventions (CPD), under the supervision of a licensed clinical psychologist (BEM). The experimental treatment will be hosted on a Centre for Pain Research managed website, and the programme will be delivered via an interactive online platform.

Over the course of the trial, those participants in the experimental group will be prompted to complete each weekly session by a reminder sent to their email via the online platform. Participants receive an email after each completed session, thanking them for completing each session, notifying them of the availability of the next session, to motivate participants to continue with the programme and to provide them with some contact time with the researchers should they have any questions. The emails are structured to maintain the participant sample, avoid participant attrition and facilitate the programme’s utility; the emails are not part of the treatment regimen. Adherence to the trial intervention will be monitored automatically via the online delivery platform and adh

Primary Outcome(s)

General levels of distress are measured using the 12-item General Health Questionnaire (GHQ-12) at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up

Secondary Outcome(s)

1. Severity of current symptoms of depressive disorders are measured using the Beck Depression Inventory (BDI) 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
2. Pain severity and the degree of interference with function is measured using the Beck Pain Inventory short form (BPI-SF) at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
3. Health-related quality of life measured using the EQ-5D at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
4. Impact of fatigue in the day-to-day functioning of patients is measured using the fatigue severity scale (FSS) at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
5. Anxiety is measured using the Generalised anxiety disorder 7-item scale (GAD-7) at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
6. Health related quality of life is measured using the medical outcomes short form-12 at 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
7. Physical and psychological impact of MS is measured using the Multiple Sclerosis Impact Scale (MSIS-29) 3 time points such as week immediately pre intervention, during the week post intervention and at 3 month follow up
8. Medication and health service use is measured using the client service receipt inventory (CSRI) at baseline, post-treatment and follow up

Secondary ID(s)

MRCG-MSIRELAND/HRB-14-07-2016

Source(s) of Monetary Support

Irish Health Research Board and the Medical Research Charities Group Joint Funding Scheme

Ethics review

Status:
Approval date:
Contact:

National University of Ireland Galway Research Ethics Committee, 11/05/2017

Results

• Results available: Yes
• Date Completed: 01/05/2019