Plain English Summary
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 talk 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 June 2022 (updated 09/07/2019, previously: December 2019)
Who is funding the study?
MS Research Australia (Australia)
Who is the main contact?
1. Dr Litza Kiropoulos
litzak@unimelb.edu.au
2. Dr Jennifer Threader
jennifer.threader@unimelb.edu.au
Trial website
Contact information
Type
Public
Primary contact
Dr Litza Kiropoulos
ORCID ID
http://orcid.org/0000-0002-1921-5904
Contact details
Melbourne School of Psychological Sciences
Melbourne Univeristy
Melbourne
3010
Australia
+61 (0)9035 4063
litzak@unimelb.edu.au
Type
Public
Additional contact
Dr Jennifer Threader
ORCID ID
Contact details
Melbourne School of Psychological Sciences
Melbourne Univeristy
Melbourne
3010
Australia
+61 (0)9035 4063
jennifer.threader@unimelb.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2016.164
Study information
Scientific title
A Phase II randomised controlled trial of an early tailored cognitive behavioural therapy based intervention for depression in those newly diagnosed with multiple sclerosis
Acronym
ACTION-MS
Study hypothesis
The aim of this study is to compare an 8-week tailored Cognitive Behavioural Therapy intervention with an 8-week Supportive Listening intervention to treat depression, anxiety and other MS-related concerns among individuals who are newly diagnosed with Multiple Sclerosis and who are mild to moderately depressed and living in Melbourne, Australia.
Ethics approval
Melbourne Health Human Research Ethics Committee, 19/08/2016, ref: HREC/16/MH/165
Study design
The study is a prospective, parallel group, assessor-blind randomized controlled multicentre (including sites in Victoria, Australia) trial among 60 adult participants who have been newly diagnosed with MS (within 5 years of having received a diagnosis) with mild to moderate depression (i.e., scored between 14-28 on the Beck Depression Inventory-II).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Mild to moderate depression among individuals newly diagnosed with MS
Intervention
Participants are randomised to either receive a specialised eight-week Cognitive Behavioural Therapy (CBT) based psychological intervention (a type of talk therapy that helps individuals learn skills targeting their thinking and behaviour) or an 8-week Supportive Listening (SL) based psychological intervention (a type of therapy that helps individuals to talk and express themselves in a non-judgmental and empathetic environment).
SL intervention involves the participant talking through their problems with the support of a psychologist. The psychologist listens to the concerns and provides counselling. The CBT sessions involves learning skills to manage depression and anxiety, such as managing unhelpful thinking styles and behaviours, in addition to learning helpful ways to manage associated pain and fatigue.
Both interventions include one-hour weekly face-to-face psychological therapy sessions for eight weeks with a psychologist working on this project in a consultation room at the Royal Melbourne Hospital in Melbourne, Australia.
Participants are followed up at three and six months to assess their depressive symptoms.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
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.
Secondary outcome measures
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-intervention), 3 months and 6 months
4. MS illness acceptance is measured using Acceptance of Chronic Health Conditions Scale (ACHC) at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months
5. Sleep quality is measured using Pittsburgh Sleep Quality Index at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months
6. Quality of life is measured using Multiple Sclerosis Quality of Life (MSQOL) at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months
7. Social support is measured using Perceived Social Support Scale at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months
8. Resilience is measured using The Resilience Scale for Adults at baseline (pre-intervention), 8 weeks (post-intervention), 3 months and 6 months
Overall trial start date
23/05/2016
Overall trial end date
30/06/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
14/06/2017
Recruitment end date
31/12/2021
Locations
Countries of recruitment
Australia
Trial participating centre
The Royal Melbourne Hospital
300 Grattan Street
Parkville
Melbourne
3050
Australia
Trial participating centre
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
Melbourne
3065
Australia
Sponsor information
Organisation
Multiple Sclerosis Research Australia
Sponsor details
PO Box 625
NSW
Sydney
2059
Australia
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
MS Research Australia
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to publish their results in a high-impact peer reviewed journal in 2020.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/07/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31959224 (added 22/01/2020)