An early tailored cognitive behavioural therapy intervention for depression in individuals newly diagnosed with multiple sclerosis
| ISRCTN | ISRCTN63987586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63987586 |
| Secondary identifying numbers | 2016.164 |
- Submission date
- 05/09/2017
- Registration date
- 20/10/2017
- Last edited
- 08/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Melbourne School of Psychological Sciences
Melbourne Univeristy
Melbourne
3010
Australia
 ORCID ID |
0000-0002-1921-5904 |
|---|---|
| Phone | +61 (0)9035 4063 |
| litzak@unimelb.edu.au |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| 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 acronym | ACTION-MS |
| Study objectives | 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(s) | Melbourne Health Human Research Ethics Committee, 19/08/2016, ref: HREC/16/MH/165 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 23/05/2016 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 14/06/2017 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Australia
Study participating centres
Parkville
Melbourne
3050
Australia
Fitzroy
Melbourne
3065
Australia
Sponsor information
Research organisation
PO Box 625
NSW
Sydney
2059
Australia
| Website | https://msra.org.au/ |
|---|---|
"ROR" |
https://ror.org/02caat392 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 08/08/2024: A manuscript related to this trial is currently in preparation and will be submitted by the end of the year. Previous publication and dissemination plan: The trialists intend to publish their results in a high-impact peer-reviewed journal in 2020. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Dr Litza Kiropoulos, email: litzak@unimelb.edu.au, consent from participants has been obtained for sharing de-identified data). Data will become available at the completion of the trial and publication of the trial results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/01/2020 | 22/01/2020 | Yes | No |
| Statistical Analysis Plan | 08/08/2024 | No | No |
Additional files
Editorial Notes
08/08/2024: The following changes were made to the study record:
1. Statistical analysis plan uploaded.
2. Publication and dissemination plan updated.
3. The intention to publish date was changed from 01/06/2024 to 31/12/2024.
17/01/2024: The following changes were made to the study record:
1. The overall study end date was changed from 31/12/2022 to 31/01/2024.
2. The intention to publish date was changed from 01/06/2023 to 01/06/2024.
3. Total final enrolment added.
10/01/2022: The following changes were made to the trial record:
1. A contact was removed.
2. The overall end date was changed from 30/06/2022 to 31/12/2022.
3. The recruitment end date was changed from 31/12/2021 to 31/12/2022.
4. The intention to publish date was changed from 30/07/2022 to 01/06/2023.
5. The plain English summary was updated to reflect these changes.
6. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Data sharing statement to be made available at a later date" to "Available on request".
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.
