Effectiveness of a Multiple Sclerosis (MS) specific psychological intervention for depression and anxiety in those newly diagnosed with MS

A pilot randomised controlled trial of a 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

ISRCTN10423371

Enrollment

Registered

2016-04-28

Start date

2013-10-01

Completion date

Unknown

Last updated

2017-02-06

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

Conditions

Depression in multiple sclerosis Mental and Behavioural Disorders Depression in multiple sclerosis

Interventions

Participants are randomly assigned using a computer generated random numbers table using an allocation ratio of 1: 1 to 1 of the 2 treatment groups. Intervention group: The tailored intervention is

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Having a definite diagnosis of MS from a neurologist 2. Scoring at least 10 on the Beck Depression Inventory-2 (BDI-2) 3. Not currently undertaking other psychological treatment for depressive and anxiety symptoms for the length of participation in the current trial 4. Speak English fluently 5. No current or lifetime diagnosis of psychosis 6. No current substance dependency 7. No gross cognitive impairment 8. No changes to medications prior and during involvement in the trial

Exclusion criteria

Exclusion criteria: 1. No definite diagnosis of MS by a neurologist 2. Currently undertaking other psychological treatment for depressive and anxiety symptoms 3. Not able to speak English fluently 4. Current or lifetime diagnosis of psychosis 5. Current substance dependency 6. Gross cognitive impairment 7. Changes to medications prior or during involvement in the trial

Design outcomes

Primary

Measure	Time frame
Level of depression measured with the Beck Depression Inventory-2 at baseline, 8 and 20 weeks.	—

Secondary

Measure	Time frame
1. Level of anxiety measured with the State Trait Anxiety Inventory at baseline, 8 and 20 weeks 2. Level of fatigue impact with the 5-item Modified Fatigue Impact Scale at baseline, 8 and 20 weeks 3. Level of pain impact on mood and behaviour measured with the Pain Effects Scale (PES) at baseline, 8 and 20 weeks 4. Multiple Sclerosis related quality of life measured with the Multiple Sclerosis Quality of Life at baseline, 8 and 20 weeks 5. Sleep quality was measured with the Pittsburgh Sleep Quality Index at baseline, 8 and 20 weeks 6. Coping was measured with the Ways of Coping questionnaire at baseline, 8 and 20 weeks 7. Acceptance of MS illness was measured with the Acceptance of Chronic Health Conditions Scale at baseline, 8 and 20 weeks 8. Level of social support was measured with the Perceived Social Support Scale at baseline, 8 and 20 weeks 9. Level of resilience was measured with the Resilience Scale for Adults at baseline, 8 and 20 weeks 20. Level of therapeutic alliance was measured with the Helping Alliance Questionnaire-Version 2 at 8 weeks 11. Acceptance of the CBT based intervention was measured with a 5-item measure developed by the first author at 8 weeks 12. Patient satisfaction with the CBT intervention was measured with an 18-item Patient Satisfaction Questionnaire designed by the first author at 8 weeks	—

Measure

Time frame

1. Level of anxiety measured with the State Trait Anxiety Inventory at baseline, 8 and 20 weeks 2. Level of fatigue impact with the 5-item Modified Fatigue Impact Scale at baseline, 8 and 20 weeks 3. Level of pain impact on mood and behaviour measured with the Pain Effects Scale (PES) at baseline, 8 and 20 weeks 4. Multiple Sclerosis related quality of life measured with the Multiple Sclerosis Quality of Life at baseline, 8 and 20 weeks 5. Sleep quality was measured with the Pittsburgh Sleep Quality Index at baseline, 8 and 20 weeks 6. Coping was measured with the Ways of Coping questionnaire at baseline, 8 and 20 weeks 7. Acceptance of MS illness was measured with the Acceptance of Chronic Health Conditions Scale at baseline, 8 and 20 weeks 8. Level of social support was measured with the Perceived Social Support Scale at baseline, 8 and 20 weeks 9. Level of resilience was measured with the Resilience Scale for Adults at baseline, 8 and 20 weeks 20. Level of therapeutic alliance was measured with the Helping Alliance Questionnaire-Version 2 at 8 weeks 11. Acceptance of the CBT based intervention was measured with a 5-item measure developed by the first author at 8 weeks 12. Patient satisfaction with the CBT intervention was measured with an 18-item Patient Satisfaction Questionnaire designed by the first author at 8 weeks

—

Countries

Australia

Contacts

Public ContactLitza Kiropoulos

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026