Depression and Anxiety SymptomsACTION-MS onliNCT07875309
An Online Tailored Cognitive Therapy-Based Intervention for Depression in Multiple Sclerosis: ACTION-MS Online
A study testing ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression. and The 'Health and Wellbeing in MS' website in people with Depression and Anxiety Symptoms and Multiple Sclerosis, run by University of Melbourne at 2 sites in 2 countries.
Trial summary
Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression and Anxiety Symptoms, Multiple Sclerosis
- What is being tested?
- ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression. and The 'Health and Wellbeing in MS' website
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Clinical diagnosis of multiple sclerosis (MS)
- Reports mild to moderate depressive symptoms, defined as a score of 14-28 on the Beck Depression Inventory-II (BDI-II)
Who cannot join
- Gross cognitive impairment that would make participation in the eight online cognitive behavioural therapy (CBT) modules distressing or difficult
- Inability to speak or read English
- Acute organic brain syndrome (e.g., delirium)
- A serious psychological disorder, including psychosis, bipolar disorder, or current substance use disorder, as determined by the Structured Clinical Interview for DSM-5 (SCID-5)
- Severe depressive symptoms, defined as a BDI-II score of 29 or greater, as assessed using the BDI-II and SCID-5 Currently undertaking psychological treatment for depression and/or anxiety
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site
Royal Melbourne Hospital
Melbourne, Victoria, 3010
Litza Kiropoulos, +61478181737, litza.kiropoulos@mh.org.au
Canada1 site
MS Barlo Centre, St Michael's Hospital
Toronto
Anthony Feinstein, 416.480 4216, ant.feinstein@utoronto.ca
About this study
Official title: A Randomized Controlled Trial of an Online Tailored Cognitive Therapy Based Intervention For Depression in Multiple Sclerosis: ACTION-MS Online
Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Cognitive behavioural therapy (CBT) has been found to be effective in treating depression in people with MS. However, many individuals with MS who would benefit from CBT for depression do not participate in face-to-face treatment due to lack of clinician referral, accessibility, modality preference, cost, and mobility and travel issues due to health reasons.
Given the acceptability and preference for telehealth treatment options, digital-based psychological interventions can be another appealing treatment option as these programs have the ability to deliver interactive CBT treatments for depression to individuals with MS at a time and location convenient to the individual.
The current trial proposes to test the acceptability, effectiveness, satisfaction and cost-effectiveness of an 8-week online depression intervention targeting individuals with multiple sclerosis and compare this intervention with an 8-week online health and wellbeing in MS informational intervention.
- Being tested
- ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression., The 'Health and Wellbeing in MS' website
- Medical subject headings
- Depression, Anxiety Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression.Device
The CBT-based online intervention is designed for people with multiple sclerosis who are experiencing mild to moderate depression. There are 8 modules which include (1) Introduction; (2) Managing depressive and anxiety symptoms: Part 1; (3) Managing depressive and anxiety symptoms: Part 2; (4) Practice challenging unhelpful thoughts; (5) Managing fatigue and pain; (6) Sleep hygiene; (7) Problem Solving; (8) Preventing relapse of depressive and anxiety symptoms.
The 'Health and Wellbeing in MS' websiteDevice
The 'Health and Wellbeing in MS' website contains health information related to MS. There are 8 sections of the website with each section focusing on a different topic. Each section includes information and some key evidence from current research about the topic. The 8 sections are: (1) Nutrition and diet; (2) Gut health and microbiome; (3) Supplements; (4) Vitamin D and sun exposure; (5) Lipids and MS; (6) Weight and obesity; (7) Smoking; (8) Other health conditions and MS.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) for depression | Experimental | 8-week online depression intervention for people with MS Receives: Device: ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression. |
| Health and Wellbeing informational intervention | Active comparator | 8-week online health and wellbeing in MS informational intervention. Receives: Device: The 'Health and Wellbeing in MS' website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, measured on Beck's Depression Inventory II
Measured: Baseline, post intervention (8 weeks) and 28-weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Anxiety SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomised, assessor-blinded, active comparator, parallel group trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875309
- Sponsor's protocol ID
- CT 36921
- Acronym
- ACTION-MS onli
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Tailored Cognitive Therapy Based Intervention For Depression in Multiple Sclerosis: ACTION-MS Online
- ClinicalTrials.gov ID
- NCT07875309
- Acronym / sponsor ID
- ACTION-MS onli / CT 36921
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with MS experience significantly high levels of depression which are higher than in any other chronic illness or neurological disorder. Depression can occur at any point in the course of the disease. Cognitive behavioural therapy (CBT) has been found to be effective in treating depression in people with MS. However, many individuals with MS who would benefit from CBT for depression do not participate in face-to-face treatment due to lack of clinician referral, accessibility, modality preference, cost, and mobility and travel issues due to health reasons.
Given the acceptability and preference for telehealth treatment options, digital-based psychological interventions can be another appealing treatment option as these programs have the ability to deliver interactive CBT treatments for depression to individuals with MS at a time and location convenient to the individual.
The current trial proposes to test the acceptability, effectiveness, satisfaction and cost-effectiveness of an 8-week online depression intervention targeting individuals with multiple sclerosis and compare this intervention with an 8-week online health and wellbeing in MS informational intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomised, assessor-blinded, active comparator, parallel group trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) for depression | Experimental | Device: ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression.8-week online depression intervention for people with MS |
| Health and Wellbeing informational intervention | Active comparator | Device: The 'Health and Wellbeing in MS' website8-week online health and wellbeing in MS informational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Clinical diagnosis of multiple sclerosis (MS)
- Reports mild to moderate depressive symptoms, defined as a score of 14-28 on the Beck Depression Inventory-II (BDI-II)
Key exclusion criteria (5 listed)
- Gross cognitive impairment that would make participation in the eight online cognitive behavioural therapy (CBT) modules distressing or difficult
- Inability to speak or read English
- Acute organic brain syndrome (e.g., delirium)
- A serious psychological disorder, including psychosis, bipolar disorder, or current substance use disorder, as determined by the Structured Clinical Interview for DSM-5 (SCID-5)
- Severe depressive symptoms, defined as a BDI-II score of 29 or greater, as assessed using the BDI-II and SCID-5 Currently undertaking psychological treatment for depression and/or anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression.The CBT-based online intervention is designed for people with multiple sclerosis who are experiencing mild to moderate depression. There are 8 modules which include (1) Introduction; (2) Managing depressive and anxiety symptoms: Part 1; (3) Managing depressive and anxiety symptoms: Part 2; (4) Practice challenging unhelpful thoughts; (5) Managing fatigue and pain; (6) Sleep hygiene; (7) Problem Solving; (8) Preventing relapse of depressive and anxiety symptoms. | Device | Cognitive Behavioural Therapy (CBT) for depression |
| The 'Health and Wellbeing in MS' websiteThe 'Health and Wellbeing in MS' website contains health information related to MS. There are 8 sections of the website with each section focusing on a different topic. Each section includes information and some key evidence from current research about the topic. The 8 sections are: (1) Nutrition and diet; (2) Gut health and microbiome; (3) Supplements; (4) Vitamin D and sun exposure; (5) Lipids and MS; (6) Weight and obesity; (7) Smoking; (8) Other health conditions and MS. | Device | Health and Wellbeing informational intervention |
Primary outcome
Depression, measured on Beck's Depression Inventory II
Time frame: Baseline, post intervention (8 weeks) and 28-weeks follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression. and The 'Health and Wellbeing in MS' website in people with Depression and Anxiety Symptoms and Multiple Sclerosis, run by University of Melbourne at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Litza Kiropoulos (+613 9035 4063, litzak@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, measured on Beck's Depression Inventory II (time frame: Baseline, post intervention (8 weeks) and 28-weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.