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

NCT07875309 | Not Yet Recruiting DMC

• 1 other identifier: CT 36921
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Depression and Anxiety Symptoms; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Depression, measured on Beck's Depression Inventory II

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

Study Arms (2)

Cognitive Behavioural Therapy (CBT) for depression

EXPERIMENTAL

8-week online depression intervention for people with MS

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.

Device: The 'Health and Wellbeing in MS' website

Interventions

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.

Cognitive Behavioural Therapy (CBT) for depression

The 'Health and Wellbeing in MS' website DEVICE

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.

Health and Wellbeing informational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (2)

Royal Melbourne Hospital

Melbourne, Victoria, 3010, Australia

Location

MS Barlo Centre, St Michael's Hospital

Toronto, Canada

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Litza Kiropoulos

CONTACT

+613 9035 4063; litzak@unimelb.edu.au

Angela Thiel

CONTACT

+61430220600; angela.thiel@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomised, assessor-blinded, active comparator, parallel group trial

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (1)