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Identifying and Managing Psychological Distress in Multiple Sclerosis: The COMPASS-MS Study

Acceptability of Identifying and Managing Psychological Distress in Multiple Sclerosis: The COMPASS-MS Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06222359
Enrollment
102
Registered
2024-01-24
Start date
2024-02-29
Completion date
2025-02-28
Last updated
2024-01-24

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

Conditions

Anxiety, Depression, Multiple Sclerosis

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).

Interventions

DEVICECOMPASS

Digital CBT to treat psychological distress in Multiple Sclerosis (MS)

Sponsors

King's College Hospital NHS Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion 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).

Design outcomes

Primary

MeasureTime frameDescription
Psychological Distress (primary outcome for a future full scale trial).baseline and 12 week follow upThe investigators will measure general psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This includes 9 items from the Patient Health Questionnaire and 7 items from the Generalised Anxiety Disorder Scale. Each item is responded to on a 4-point Likert Scale (0-3) (minimum score: 0, maximum score: 48). Higher scores indicate higher levels of depression and anxiety.

Secondary

MeasureTime frameDescription
Reach of screening and COMPASS MS interventionBaseline only\- The clinical team will collect data on the route of referral to mental health team (completed routine screening, was referred/self-referred).
Efficacy: psychological outcomesbaseline and 12 week follow up\- The investigators will measure Intolerance of Uncertainty using the Intolerance of Uncertainty Scale-12 item. Items are rated on a 5-point Likert scale (minimum score: 12, maximum score: 60). Higher scores indicate a greater intolerance of uncertainty.
Efficacy: Psycho-social outcomesbaseline and 12 week follow up\- The investigators will measure Healthcare usage using the 4 service use items from the Client Service Receipt Inventory (CSRI).
Implementation of COMPASSpost treatment (12 week follow up)The investigators will investigate the implementation of COMPASS by collecting descriptive data on the number of patients who require digital support to use COMPASS-MS
Adoption12 weeks follow up (post treatment)We will qualitatively explore the Adoption of COMPASS. We will conduct two nested qualitative studies. 1) we will interview patients and healthcare professionals at Kings College Hospital to explore the barriers and facilitators of implementing the COMPASS-MS care pathway locally at King's Hospital (KCH) (Qualitative Study A) 2 ) we will interview key stakeholders outside of KCH to explore the barriers and facilitators of scaling it across Neurology Services outside KCH (Qualitative Study B).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026