Condition category
Mental and Behavioural Disorders
Date applied
05/09/2017
Date assigned
20/10/2017
Last edited
26/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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 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.

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

31/12/2019

Reason abandoned

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

16/05/2017

Recruitment end date

01/06/2019

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

https://msra.org.au/

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

01/01/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2017: Internal review.