title: A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis.
abstract: BACKGROUND
  To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis.
  
  
  METHODS
  The current study presents a pilot, parallel group randomized controlled trial (RCT) with an allocation ratio of 1:1 conducted in a large research and teaching hospital in Melbourne, Australia. 30 individuals with a mean age of 36.93 years (SD = 9.63) who were newly diagnosed with multiple sclerosis (MS) (X = 24.87 months, SD = 15.61) were randomized to the CBT intervention (n = 15) or treatment as usual (TAU) (n = 15). The primary outcome was level of depressive symptoms using the Beck Depression Inventory-II (BDI-II). Secondary outcomes were level of anxiety, fatigue and pain impact, sleep quality, coping, acceptance of MS illness, MS related quality of life, social support, and resilience. Tertiary outcomes were acceptability and adherence to the intervention.
  
  
  RESULTS
  Large between group treatment effects were found for level of depressive symptoms at post and at 20 weeks follow-up (d = 1.66-1.34). There were also small to large group treatment effects for level of anxiety, fatigue and pain impact, sleep quality, MS related quality of life, resilience, and social support at post and at 20 weeks follow-up (d = 0.17-1.63). There were no drop-outs and participants completed all treatment modules. All participants reported the treatment as 'very useful', and most (73.4%) reported that the intervention had addressed their problems 'completely'.
  
  
  CONCLUSIONS
  These data suggest that the tailored early intervention is appropriate and clinically effective for the treatment of depressive symptoms in those newly diagnosed with MS. A larger RCT comparing the CBT intervention with an active comparative treatment with longer term follow-up and cost effectiveness analyses is warranted. The pilot trial has been retrospectively registered on 28/04/2016 with the ISRCTN registry (trial ID ISRCTN10423371).
authors.affiliation: Melbourne School of Psychological Sciences, University of Melbourne, Victoria, 3010, Australia. litzak@unimelb.edu.au.|Psychology Department, Royal Melbourne Hospital, Parkville, Victoria, Australia. litzak@unimelb.edu.au.
authors.forename: Litza A
authors.initials: LA
authors.lastname: Kiropoulos
authors.affiliation: Melbourne Brain Centre and MS unit, Royal Melbourne Hospital, Parkville, Victoria, Australia.|Centre for Neuroscience and the Melbourne Neuroscience Institute, University of Melbourne, Parkville, Victoria, Australia.|Florey Neuroscience Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Trevor
authors.initials: T
authors.lastname: Kilpatrick
authors.affiliation: Department of Psychiatry, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Alex
authors.initials: A
authors.lastname: Holmes
authors.affiliation: Melbourne School of Psychological Sciences, University of Melbourne, Victoria, 3010, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Threader
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D001007:Anxiety / Q000191:economics / Q000523:psychology; D001315:Australia; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003863:Depression / Q000191:economics / Q000523:psychology / Q000628:therapy*; D005221:Fatigue / Q000191:economics / Q000523:psychology; D005260:Female; D006296:Health Services / Q000191:economics; D006801:Humans; D008297:Male; D009103:Multiple Sclerosis / Q000191:economics / Q000523:psychology*; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012893:Sleep Wake Disorders / Q000191:economics / Q000523:psychology; D012944:Social Support; D016896:Treatment Outcome
keywords: Anxiety; Cognitive behavioral therapy (CBT); Depression; Early intervention; Multiple sclerosis; Newly diagnosed