Mindfulness Intervention for Multiple Sclerosis (MIMS)

• Register: ISRCTN
• Last refreshed on: 8 January 2018
• Main ID: ISRCTN93263909
• Date of registration: 28/11/2012
• Prospective Registration: No
• Primary sponsor: King's College London (UK)
• Public title: Mindfulness Intervention for Multiple Sclerosis (MIMS)
• Scientific title: Pilot evaluation of distance delivered mindfulness based cognitive therapy for people affected by primary and secondary progressive multiple sclerosis
• Date of first enrolment: 26/11/2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN93263909
• Study type: Interventional
• Study design: Pilot randomised controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Angeliki Bogosian

Key inclusion & exclusion criteria

Inclusion criteria: 1. Participants must be diagnosed with primary progressive or secondary progressive MS by a neurologist and defined as people with MS with documented decline in neurological function for a period of a year or more without relapses
2. Participants must have internet access at home
3. Participants must have significant level of distress determined by a score of greater than 3 on the General Health Questionnaire (GHQ-12); (Goldberg & Williams, 1988). This cut-off score was determined following recommendations for MS (Lincoln et al., 2011; Nicholl, Lincoln, Francis, & Stephan, 2001) that participants scoring 3 or above in total were classified as having clinically significant distress.
Exclusion criteria: 1. Participants who have severe cognitive impairment that would make participation in the MBCT and home practice of mindful meditation problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, (Brandt et al., 1993). People with a score of less than 20 will be excluded.
2. Participants who have high suicide risk, in which case their needs are more appropriately addressed by a referral to another psychological service (e.g. psychiatrist, clinical psychologist, MS special mental health nurse). This will be assessed using the Clinical Outcome of Routine Evaluation (CORE-10; (Evans et al., 2002). People with a score above 20 will be excluded and referred to further support.
3. Participants who have serious psychological disorders for which MBCT would be inappropriate (including psychotic disorders or active substance abuse problems)
4. Participants who have severe hearing impairment
5. Participants who are currently participating in other psychological therapies
6. Participants who have prior formal training in mindfulness methods

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Primary and secondary progressive multiple sclerosis
Nervous System Diseases
Multiple sclerosis

Intervention(s)

Mindfulness based cognitive therapy

Primary Outcome(s)

The General Health Questionnaire (Goldberg & Williams, 1988) is designed to measure general levels of distress in people in the community and medical settings. The measure is uncontaminated by the experience of MS related somatic symptoms and a recent study showed the GHQ was the most treatment responsive measure of psychological distress in three discrete MS samples (Hobart, Riazi, Lamping, Fitzpatrick, & Thompson, 2005).

Secondary Outcome(s)

1. Self-efficacy for managing chronic disease (Lorig et al., 1996). This is a brief 6-item scale. We chose this scale, as it is much less burdensome for participants and it covers several domains relevant to many chronic illnesses, including MS, symptom control, role function, emotional functioning and communicating with health professionals. This scale has been used to previous psychological clinical trials (Lorig, Sobel, Ritter, Laurent, & Hobbs, 2001).
2. Pain intensity will be assessed with a numerical rating scale (Price, Bush, Long, & Harkins, 1994) (scaled from 0 to 10) addressing the average pain, which is associated with MS according to the patient's point of view. Thereby, 0 represents no pain and 10 the most painful sensation imaginable.
3. Fatigue Severity Scale (FSS; (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989) is a 9-item widely used scale. It assess the impact of fatigue in the daily living of patients with three items related to physical impact, three items to the psychological environment and the remainder three are more generic (Bergamaschi, Romani, Versino, Poli, & Cosi, 1997). The FSS has been chosen to measure fatigue in many MS studies (Bergamaschi et al., 1997; Flachenecker)
et al., 2002; Leocani et al., 2001) and clinical trials (Krupp et al., 1995; Montalban et al., 2002)
4. Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983). This scale has been found to be effective in assessing the symptoms of severity of anxiety and depression in both secondary and primary care patients (Herrmann, 1997).
5. Multiple Sclerosis Impact Scale (MSIS-29; Hobart et al., 2001). This scale measures the physical (20 items) and the psychological (9 items) impact of multiple sclerosis. MSIS-29 scales have shown good variability, small floor and ceiling effects, high internal consistency and high test-retest reliability (Hobart et al., 2001; Hobart et al., 2005).

Secondary ID(s)

MIMS trial, v1

Source(s) of Monetary Support

MS Society (UK) ref: 961/11