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Identifying and Managing Psychological Distress in Multiple Sclerosis: The COMPASS-MS Study | Clinical Trials | Clareo Health

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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

NCT06222359•King's College London

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+8 more criteria

Key Dates

Start Date

February 1, 2024

Primary Completion Date

February 1, 2025

Completion Date

February 1, 2025

Last Updated

January 24, 2024

Enrollment

102

ESTIMATED participants

Conditions

Multiple SclerosisDepressionAnxiety

Interventions

COMPASS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

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