Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

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
2. Dr Jennifer Threader

Trial website

Contact information



Primary contact

Dr Litza Kiropoulos


Contact details

Melbourne School of Psychological Sciences
Melbourne Univeristy
+61 (0)9035 4063



Additional contact

Dr Jennifer Threader


Contact details

Melbourne School of Psychological Sciences
Melbourne Univeristy
+61 (0)9035 4063

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.


Mild to moderate depression among individuals newly diagnosed with MS


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

The Royal Melbourne Hospital
300 Grattan Street Parkville

Trial participating centre

St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy

Sponsor information


Multiple Sclerosis Research Australia

Sponsor details

PO Box 625

Sponsor type

Research organisation



Funder type

Research council

Funder name

MS Research Australia

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in (added 22/01/2020)

Publication citations

Additional files

Editorial Notes

22/01/2020: Publication reference added. 16/07/2019: The recruitment start date was changed from 16/05/2017 to 14/06/2017. 09/07/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/06/2019 to 31/12/2021. 2. The overall end date was changed from 31/12/2019 to 30/06/2022. 3. The intention to publish date was changed from 01/01/2020 to 30/07/2022. 4. The plain English summary was updated to reflect these changes. 26/10/2017: Internal review.