Authors
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Bogosian, Angeliki -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2012
INTERVENTION: Mindfulness based cognitive therapy CONDITION: Primary and secondary progressive multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: 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: 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). 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.
Epistemonikos ID: 6c773931c6b50f6c8a1216d97978a2d30a2bf6af
First added on: Aug 22, 2024