Clinical trial NCT06222359: Identifying and Managing Psychological Distress in Multiple Sclerosis: The COMPASS-MS Study
Official title: Acceptability of Identifying and Managing Psychological Distress in Multiple Sclerosis: The COMPASS-MS Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Depression
Anxiety
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2024-01-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with Multiple Sclerosis (MS) and co-morbid psychological distress Healthcare professionals and Key stakeholders of people living with MS and co-morbid psychological distress

Brief summary: The aim of this pre-post observational study is to explore if it is feasible to implement 1) routine mental health screening and b) an online Cognitive Behavioural Therapy (CBT) treatment for anxiety and/or depression (named COMPASS-MS) for people living with Multiple Sclerosis (MS) (PwMS) and co-morbid psychological distress in routine care.

Detailed description: The aim of the project is to conduct a feasibility study regarding the implementation of a) routine mental health screening and b) the COMPASS-MS programme as a low-intensity online CBT treatment for anxiety and/or depression in a large English National Health Service (NHS) secondary care MS Clinic.

The intervention will be supported by COMPASS-trained therapists, who will receive supervision from a Clinical Health Psychologist and the Multi-Disciplinary Team (Quantitative Study A). We will also conduct two nested qualitative studies to explore the barriers and facilitators of implementing the COMPASS-MS care pathway locally at King's Hospital (KCH) (Qualitative Study A) and scaling it across Neurology Services outside KCH (Qualitative Study B).

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).

Primary outcomes:
measure: Psychological Distress (primary outcome for a future full scale trial).
timeFrame: baseline and 12 week follow up
Secondary outcomes:
measure: Reach of screening and COMPASS MS intervention
timeFrame: Baseline only
measure: Reach of screening and COMPASS MS intervention
timeFrame: Baseline only
measure: Reach of screening and COMPASS MS intervention
timeFrame: Baseline only
measure: Reach of screening and COMPASS MS intervention
timeFrame: Baseline only
measure: Efficacy: psychological outcomes
timeFrame: baseline and 12 week follow up
measure: Efficacy: psychological outcomes
timeFrame: baseline and 12 week follow up
measure: Efficacy: Psycho-social outcomes
timeFrame: baseline and 12 week follow up
measure: Implementation of COMPASS
timeFrame: post treatment (12 week follow up)
measure: Implementation of COMPASS
timeFrame: post treatment (12 week follow up)
measure: Implementation of COMPASS
timeFrame: post treatment (12 week follow up)
measure: Implementation of COMPASS
timeFrame: post treatment (12 week follow up)
measure: Adoption
timeFrame: 12 weeks follow up (post treatment)
Other outcomes:
Locations:
Study officials:
References:
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