Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT06222359
Eligibility Criteria:
Patients will be eligible for inclusion for the COMPASS-MS intervention if they are:
1. Aged ≥18 years
2. Have a diagnosis of MS.
3. Speak English to a sufficiently high standard to allow them to interact with digital CBT programmes.
4. Have access to a computer and email account to allow them to register with the digital CBT programme, and a basic understanding of internet use.
5. Presence of depression and/or anxiety and/or psychological distress evidenced by:
i. A score of ≥ 5 on the nine item self-report measure of depression: PHQ-9 (Kroenke et al., 2001) AND/OR ii. A score of ≥ 5 on the seven item self-report measure of anxiety: GAD-7 (Spitzer et al., 2006).
OR iii. A score of ≥ 10 on the composite measure of depression and anxiety PHQ-ADS (Kroenke et al., 2016).
AND iv. Distress is related to their MS (i.e. answer "yes" or "sometimes" to "Is your distress linked to your MS?"
The below eligibility criteria apply to HCPs who have experience in engaging with COMPASS-MS care pathways at King's College Hospital (KCH).
Healthcare providers (HCPs) will be eligible for inclusion if they meet all or any of the below criteria:
1. Work in the Neurology Service at KCH providing care to PwMS
2. Have experience of either: i) Assessing and triaging patients for psychological distress and/or ii) Providing therapist support to the users of COMPASS-MS.
3. Work in or alongside KCH who are implementing: i) Routine mental health screening ii) COMPASS digital CBT (e.g. pharmacy/physiotherapy commissioning bodies).
Key Stakeholder Inclusion Criteria
Key Stakeholders from Neurology services external to KCH will be invited to take part in an interview if they meet all or any of the below criteria:
1. Work in a Neurology Service in England including both inpatient services and MS therapy centres.
2. Have direct patient experience with working with PwMS (e.g. Neurologist, Doctor, Nurse, Reception)
3. Work alongside a Neurology services in England and are involved in the care of PwMS (e.g. pharmacy/physiotherapy/commissioning bodies).
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06222359
Study Brief:
Protocol Section:
NCT06222359