An early tailored cognitive behavioural therapy intervention for depression in individuals newly diagnosed with multiple sclerosis

A Phase II randomised controlled trial of an early tailored cognitive behavioural therapy based intervention for depression in those newly diagnosed with multiple sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63987586

Enrollment

Registered

2017-10-20

Start date

2017-06-14

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate depression among individuals newly diagnosed with MS Mental and Behavioural Disorders Mild to moderate depression among individuals newly diagnosed with MS

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Australia

Contacts

Public ContactLitza Kiropoulos

litzak@unimelb.edu.au+61 (0)9035 4063

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 6, 2026