Abstract
BackgroundMultiple 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.MethodsACTION-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.DiscussionThere 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 registrationISRCTN trials registry, ISRCTN63987586. Current controlled trials. Retrospectively registered on 20 October 2017.
Highlights
There is a scarcity of psychological interventions for depression targeting the newly diagnosed period
The current trial will provide data on the effectiveness of a tailored cognitive behavioural therapy (CBT) intervention for the treatment of depression in those newly diagnosed with Multiple sclerosis (MS)
Depression is common in individuals newly diagnosed with MS [1, 2] and, if left untreated, it will contribute to further deterioration, having an impact on the course of MS [19] and immune functioning [5], result in the exacerbation of MS relapses [17], contribute to higher suicide rates [20] and possibly affect adherence to medical advice and treatments [16, 21]
Summary
Introduction to the tailoredPsycho-education on CBT model for treatment of depression and anxiety, fatigue and painCBT program management, sleep hygiene; the link between thoughts, emotions, and behaviour; self-assessment activity identifying depressive, anxiety and MS symptoms; introduction to grief and loss model and acceptance of MS illness; self- assessment of stage of grief/loss; introduction of thought monitoring forms and provision of psycho-educational reading materials on depression, anxiety and MS and adjusting to living with MSModule 2 and Module 3Managing depressive and anxiety symptomsAssist client to identify link between trigger events, thoughts, emotions and behaviour; identify situations that trigger low mood and anxiety; introduction to unhelpful thinking styles and how they contribute and maintain low mood and anxiety; introduce and discuss behavioural activation strategies such as pleasant activity scheduling including physical activity; mindfulness-based controlled breathing; progressive muscle relaxation to assist in the management of negative emotions; provide guided controlled breathing, progressive muscle relaxation and sleep hygiene audio tracks; provide psycho-educational material on the benefits of controlled breathing, progressive muscle relaxation and sleep hygieneChallenging unhelpful thoughtsIdentifying own unhelpful thinking styles/errors using the thought monitoring form; discussion of how unhelpful thinking styles lead to negative emotions and unhelpful behaviours; introduction of how to manage and challenge unhelpful thoughts; finding alternative thoughts activity in session; provide psycho-educational material about challenging negative thoughts and coming up with alternative more helpful thoughts; provide thought monitoring, relaxation and pleasant activities forms for homeworkManaging fatigue and painUnderstanding pain and fatigue in MS from a cognitive behavioural perspective; discussion of pain and fatigue “traps”; provide psycho-educational material on fatigue and pain and depression cycle; identification of individual fatigue and pain cycle; identification of negative thoughts; identifying unhelpful thinking styles related to fatigue and pain; identification and discussion of more helpful thoughts Sleep hygieneWhat is good sleep hygiene? Discussion of strategies to improve sleep such as establishing good sleep habits; provide psycho-educational material around factors that influence sleep. CBT program management, sleep hygiene; the link between thoughts, emotions, and behaviour; self-assessment activity identifying depressive, anxiety and MS symptoms; introduction to grief and loss model and acceptance of MS illness; self- assessment of stage of grief/loss; introduction of thought monitoring forms and provision of psycho-educational reading materials on depression, anxiety and MS and adjusting to living with MS. In a recent systematic review and meta-analysis looking at interventions of depression in individuals with MS, Fiest and colleagues [18] identified eight randomised controlled trials that employed CBT-based interventions for the treatment of depression in those with MS and found that the severity of depression scores improved in all trials (standardised mean difference [SMD] – 0.45; 95% confidence interval [CI] − 0.74, − 0.16) Despite these promising findings, research in the treatment of depression amongst individuals with MS has been limited in its methodology, with a paucity of interventions targeted towards individuals who are newly diagnosed. Provision of CBT may increase psychological wellbeing, lead to improvements in treatment thereby altering MS disease progression and lead to better social and functional outcomes for individuals with MS [2]
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