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

INTERVENTION: 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 an 8‐week face to face cognitive behavioural based intervention aimed at decreasing the level of depression (primary outcome), anxiety, fatigue and pain impact and to contribute to improvements in levels of quality of life, sleep difficulties, MS illness acceptance, active coping skills, social support and resilience (secondary outcomes) in those newly diagnosed with MS. All sessions (apart from the first session which is 1.5 hours) are 1 hour in duration. Control group: Those allocated to the treatment as usual (TAU) do not obtain any psychological treatment for depression or anxiety for the duration of their involvement in the trial (20 weeks). Individuals receive usual medical care from their neurologist which may include up to 3 visits for medication review during the course of involvement in the current trial. Participants in both groups are followed up at 8 and 20 weeks. CONDITION: Depression in multiple sclerosis ; Mental and Behavioural Disorders ; Depression in multiple sclerosis PRIMARY OUTCOME: Level of depression measured with the Beck Depression Inventory‐2 at baseline, 8 and 20 weeks. SECONDARY OUTCOME: 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 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