title: Protocol for the saMS trial (supportive adjustment for multiple sclerosis): a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis.
abstract: BACKGROUND
  Multiple Sclerosis (MS) is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS.
  
  
  METHODS
  This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks) will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks), mid-therapy (week 5 of therapy), post-therapy (15 weeks) and at six months (26 weeks) and twelve months (52 weeks) follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place.
  
  
  CONCLUSIONS
  This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the efficacy, cost-effectiveness and acceptability of the interventions as well as mechanisms of psychosocial adjustment.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN91377356.
authors.affiliation: School of Psychology, University of Southampton, Highfield Campus, Southampton, SO17 1BJ, UK . remm@soton.ac.uk
authors.forename: Rona
authors.initials: R
authors.lastname: Moss-Morris
authors.forename: Laura
authors.initials: L
authors.lastname: Dennison
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
authors.forename: Sabine
authors.initials: S
authors.lastname: Landau
authors.forename: Suzanne
authors.initials: S
authors.lastname: Roche
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.forename: Trudie
authors.initials: T
authors.lastname: Chalder
mesh_terms: D000203:Activities of Daily Living / Q000523:psychology; D000328:Adult; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D006801:Humans; D009103:Multiple Sclerosis / Q000191:economics / Q000523:psychology*; D018579:Patient Selection; D011788:Quality of Life; D012917:Social Adjustment; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
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