A Phase II randomised controlled trial of an early tailored cognitive behavioural therapy based intervention for depression in those newly diagnosed with multiple sclerosis

Completed (inferred)MS (type not specified)ISRCTN63987586

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • Severity of depression is measured using the Beck Depression Inventory-II (BDI-II) at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months.

    Mood and sleep

Other measures (1)

  • 1. Level of anxiety is measured using State Trait Anxiety Inventory (STAI) at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months 2. Fatigue is measured using the Fatigue Impact Scale at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months 3. Pain impact measured using Pain Effects Scale at baseline (pre-intervention), 8 weeks (post-interventi

    FatiguePainMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

Inclusion: 1. Mild to moderately depressed patients with MS 2. Diagnosed with MS within the last 5 years and are considered newly diagnosed. 3. Adult (i.e., 18-65 years old) Exclusion: 1. Gross cognitive impairment that would make participation in the 8 one hour sessions of Cognitive Behavioural Therapy distressing 2. Unable to speak or read English 3. Acute organic brain syndrome (e.g., delirium) 4. Serious psychological disorder (e.g., psychosis) 5. Assessed with the BDI-II and the SCID-5 as being severely depressed 6. Already undertaking psychological treatment for depression/anxiety 7. Taking antidepressants for less than two months

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 a condition that causes a wide range of different symptoms, from vision, arm and leg movements, balance or sensation. It can cause mild to serious disabilities. Compared to other chronic diseases and neurological (brain) disorders, rates of depression in individuals with MS is high, in particular around the time of diagnosis. To our knowledge there is no research, in Australia or internationally, specifically examining the psychological treatment of individuals presenting with psychological concerns in individuals within 5-years post Multiple Sclerosis diagnosis (considered newly diagnosed). The aim of this study is to examine the use of an early tailored Cognitive Behavioural Therapy (CBT) (a type of talking therapy that helps individuals learn skills targeting their thinking and behaviour) for depression in individuals newly diagnosed with Multiple Sclerosis. Who can participate? Adults aged 18 to 65 who are diagnosed with MS in the last five years. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive a specialised CBT therapy which helps them learn skills to target their thinking and behaviour. Those in the second group receive a supportive listening based treatment that helps participants express themselves in a non-judgmental and empathetic environment. Both groups attend the therapy for one an hour a week for eight weeks. Participants are followed up at three and six months to assess their depressive symptoms. What are the possible benefits and risks of participating? Participants may benefit from speaking a psychologist about their concerns and learning skills to effectively manage their depressive, anxiety, pain and fatigue symptoms. There are no anticipated risks with participating. Where is the study run from? 1. The Royal Melbourne Hospital (Australia) 2. St Vincent's Hospital Melbourne (Australia) When is the study starting and how long is it expected to run for? May 2016 to January 2024 Who is funding the study? MS Research Australia (Australia) Who is the main contact? Dr Litza Kiropoulos litzak@unimelb.edu.au

Papers

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History

    1. Started

      Jun 2017

    2. Finished

      Jan 2024

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