Effectiveness of a Multiple Sclerosis (MS) specific psychological inte
A pilot randomised controlled trial of a tailored cognitive behavioural therapy based intervention for depression in those newly diagnosed with multiple sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Level of depression measured with the Beck Depression Inventory-2 at baseline, 8 and 20 weeks.
Mood and sleep
Other measures (1)
1. Level of anxiety measured with the State Trait Anxiety Inventory at baseline, 8 and 20 weeks 2. Level of fatigue impact with the 5-item Modified Fatigue Impact Scale at baseline, 8 and 20 weeks 3. Level of pain impact on mood and behaviour measured with the Pain Effects Scale (PES) at baseline, 8 and 20 weeks 4. Multiple Sclerosis related quality of life measured with the Multiple Sclerosis Qua
FatiguePainMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified)
Show the full criteria
Inclusion criteria
Inclusion: 1. Having a definite diagnosis of MS from a neurologist 2. Scoring at least 10 on the Beck Depression Inventory-2 (BDI-2) 3. Not currently undertaking other psychological treatment for depressive and anxiety symptoms for the length of participation in the current trial 4. Speak English fluently 5. No current or lifetime diagnosis of psychosis 6. No current substance dependency 7. No gross cognitive impairment 8. No changes to medications prior and during involvement in the trial Exclusion: 1. No definite diagnosis of MS by a neurologist 2. Currently undertaking other psychological treatment for depressive and anxiety symptoms 3. Not able to speak English fluently 4. Current or lifetime diagnosis of psychosis 5. Current substance dependency 6. Gross cognitive impairment 7. Changes to medications prior or during involvement in the trial
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of disturbances including loss of vision, problems with balance and coordination and weakness in the arms or legs. Depression is very common in people with MS and has been reported to be particularly bad at the time of diagnosis or the early stages of the disease. Cognitive behavioural therapy (BCT) is a type of taking therapy which works by changing the way a person thinks and behaves. There is currently little to no research looking at the effectiveness of CBT in the treatment of depression in the first two years following diagnosis. The aim of this study is to evaluate the effectiveness of an eight week course of tailored CBT for people with MS suffering from depression. Who can participate? Adults with MS who are suffering from depression. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group take part in an eight week face to face course of CBT based therapy. His involves weekly sessions lasting for two hours (1.5 hours for the first session), and help to improve quality of life, sleep difficulties, MS illness acceptance, active coping skills, social support and resilience. Those in the second group receive treatment as usual for the duration of the study. At the start of the study and then again after 8 ad 20 weeks, participants in both groups complete a range of questionnaires in order to assess their depressive symptoms and quality of life. What are the possible benefits and risks of participating? Participants may benefit from improvement in their depressive symptoms. There are no notable risks involved with taking part in the study. Where is the study run from? Royal Melbourne Hospital (Australia) When is the study starting and how long is it expected to run for? October 2011 to December 2016 Who is funding the study? University of Melbourne (Australia) Who is the main contact? Dr Litza Kiropoulos
Papers
Loading reviews and guidelines…
History
Started
Oct 2013
Finished
Dec 2015