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

Not yet recruiting

• Conditions: Multiple Sclerosis; Anxiety; Depression

• Registration Number: NCT06222359
• Lead Sponsor: King's College London

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).

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2024-01-15
• Last Update Submitted: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychological Distress (primary outcome for a future full scale trial).	baseline and 12 week follow up	The 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 Outcome Measures

Name	Time	Method
Reach of screening and COMPASS MS intervention	Baseline only	- the clinical team will collect data on the outcome of screening (e.g eligible for COMPASS-MS intervention or not)
Implementation of COMPASS	post treatment (12 week follow up)	The investigators will investigate the implementation of COMPASS by collecting descriptive data on the dropout rate of COMPASS.
Efficacy: psychological outcomes	baseline and 12 week follow up	- The investigators will measure Expression of emotion will be measured using the Beliefs about Emotions Scale.
Efficacy: Psycho-social outcomes	baseline and 12 week follow up	- The investigators will measure Healthcare usage using the 4 service use items from the Client Service Receipt Inventory (CSRI).
Adoption	12 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).