Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial

Trials

Lisa Taylor¹  Trevor Kilpatrick¹  Tomas Kalincek¹  Tissa Wijeratne²  Anneke Van Der Walt³  Leonid Cherulov⁴  Neil Simpson-O’Brien⁵  Vanja Rozenblat⁶  Litza Kiropoulos⁶  Jennifer Threader⁶  Elizabeth McDonald⁷ 

[1] Department of Neurology, Royal Melbourne Hospital;Department of Neurology, Western Health;Department of Neurosciences, Monash University;Florey Institute of Neuroscience and Mental Health;Melbourne Dental School, University of Melbourne;Melbourne School of Psychological Sciences, University of Melbourne;Rehabilitation and Neuroimmunology, Department of Neuroscience, St Vincent’s Hospital;

关键词: Depression;    Cognitive behavioural therapy (CBT);    Multiple sclerosis;    Newly diagnosed;    Randomised controlled trial;    Anxiety;   

DOI  :  10.1186/s13063-019-4018-8

来源: DOAJ

【 摘 要 】

Abstract Background Multiple sclerosis (MS) is an unpredictable, chronic neurological disease accompanied with high rates of depression and anxiety, particularly in the early stages of diagnosis. There is evidence to suggest that cognitive behavioural therapy (CBT) is effective for the treatment of depression amongst individuals with MS; however, there is a paucity of tailored CBT interventions designed to be offered in the newly diagnosed period. This trial is the first to assess the effectiveness and cost-effectiveness of a tailored CBT intervention compared to a supportive listening (SL) intervention amongst individuals with MS who are depressed. Methods ACTION-MS is a two-arm parallel group, assessor-blinded, active comparator, randomised controlled trial which will test whether a tailored CBT-based intervention compared to an SL intervention can reduce depression and related factors such as anxiety, fatigue, pain and sleep problems in those newly diagnosed with MS. Sixty participants who are within 5 years of having received a diagnosis of MS and scored within the mild to moderate range of depression on the Beck Depression Inventory (BDI-II) will be recruited from MS clinics located across three hospital sites in Melbourne, Australia. The primary outcome is depression severity using the BDI-II at post-assessment. Intervention satisfaction and acceptability will be assessed. A cost-effectiveness analysis will also be conducted. Data will be analysed on an intention-to-treat basis. Discussion There is a scarcity of psychological interventions for depression targeting the newly diagnosed period. However, interventions during this time point have the potential to have a major impact on the mental and physical wellbeing of those newly diagnosed with MS. The current trial will provide data on the effectiveness of a tailored CBT intervention for the treatment of depression in those newly diagnosed with MS. Findings will also provide effect size estimates that can be used to power a later-stage multi-centre trial of treatment efficacy, and will provide information on the mechanisms underlying any treatment effects and cost-effectiveness data for delivering this intervention in outpatient MS clinics. Trial registration ISRCTN trials registry, ISRCTN63987586 . Current controlled trials. Retrospectively registered on 20 October 2017.

【 授权许可】

Unknown