A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis

Statistical Inference for Stochastic Processes, Dec 2016

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).

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A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis

Kiropoulos et al. BMC Psychiatry A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis Litza A. Kiropoulos 0 1 Trevor Kilpatrick 2 4 5 Alex Holmes 3 Jennifer Threader 1 0 Psychology Department, Royal Melbourne Hospital , Parkville, Victoria , Australia 1 Melbourne School of Psychological Sciences, University of Melbourne , Victoria 3010 , Australia 2 Melbourne Brain Centre and MS unit, Royal Melbourne Hospital , Parkville, Victoria , Australia 3 Department of Psychiatry, University of Melbourne , Parkville, Victoria , Australia 4 Florey Neuroscience Institute of Neuroscience and Mental Health, University of Melbourne , Parkville, Victoria , Australia 5 Centre for Neuroscience and the Melbourne Neuroscience Institute, University of Melbourne , Parkville, Victoria , Australia 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). Depression; Cognitive behavioral therapy (CBT); Multiple sclerosis; Newly diagnosed; Early intervention; Anxiety - Background Multiple sclerosis (MS) is the most common neurological disorder in young adults. It is estimated that 2.5 million people are living with MS worldwide. Diagnosis of MS is typically between 20 and 40 years of age, three quarters of whom are female [1]. MS has a range of consequences on mental health. Depression and anxiety have been found to be common in individuals with MS and have been reported to be at clinically high levels especially in the early stages of the illness [2–4]. The lifetime prevalence of depression among individuals with MS has been found to be 50% [5] and point prevalence rates range from 15 to 26% [6]. Similarly, anxiety affects between 16 and 45% of the MS population [7, 8] and has been associated with younger age of onset, disease severity, fatigue [9] and severity of depressive symptoms [10]. Two studies suggest that up to 36% of MS patients continue to have high levels of depressive and anxiety symptoms in the first years after diagnosis [3, 11]. CBT for the treatment of depression in people diagnosed with MS have demonstrated significant reductions in depression. A review of seven CBT studies (individual (3 studies), group (3 studies) and by computer (1 study)) found a medium treatment effect of 0.5 SD [12]. One study compared individual CBT with sertraline and group therapy and found that those in the CBT and the sertraline groups showed greater improvements in their levels of depression compared to those in group therapy. In addition, those in the individual CBT group displayed improvements in mood, coping, and suicidal ideas [13]. Askey-Jones, David, Silber, Shaw and Chalder (2013) [14] also examined the effectiveness of a CBT delivered intervention and found that CBT resulted in statistically significant decreases in depression and anxiety with large effect sizes. More recently, Fischer et al., (2015) [15] conducted a RCT comparing a CB (...truncated)


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Litza A. Kiropoulos, Trevor Kilpatrick, Alex Holmes, Jennifer Threader. A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis, Statistical Inference for Stochastic Processes, 2016, pp. 435, Volume 16, Issue 1, DOI: 10.1186/s12888-016-1152-7