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Not yet recruitingNCT07875309ACTION-MS onliUpdated Oct 15, 2026

An Online Tailored Cognitive Therapy-Based Intervention for Depression in Multiple Sclerosis: ACTION-MS Online

An interventional study of ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression. and The 'Health and Wellbeing in MS' website in Depression and Anxiety Symptoms and Multiple Sclerosis, sponsored by University of Melbourne. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by University of Melbourne · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Depression and Anxiety Symptoms
  • Multiple Sclerosis
03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 240 is above the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Melbourne is the lead sponsor of 86 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Cognitive Behavioural Therapy (CBT) for depression

    8-week online depression intervention for people with MS

    Device: ACTION-MS website - an 8-week cognitive behavioural therapy intervention for depression.

  • Active comparator
    Health and Wellbeing informational intervention

    8-week online health and wellbeing in MS informational intervention.

    Device: The 'Health and Wellbeing in MS' website

Interventions

  • DeviceACTION-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.

  • DeviceThe 'Health and Wellbeing in MS' website

    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.

06

What researchers measure

Primary outcomes

  1. Depression, measured on Beck's Depression Inventory II

    Time frame: Baseline, post intervention (8 weeks) and 28-weeks follow up

07

Study locations

2 sites
  • Royal Melbourne Hospital
    Melbourne, Victoria 3010, Australia
  • MS Barlo Centre, St Michael's Hospital
    Toronto, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875309
Lead sponsor
University of Melbourne
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Litza Kiropoulos
Contact
litzak@unimelb.edu.au
+613 9035 4063
Angela Thiel
Contact
angela.thiel@unimelb.edu.au
+61430220600

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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