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

January 15, 2024 updated by: King's College London

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Distress (primary outcome for a future full scale trial).
Time Frame: 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.
baseline and 12 week follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach of screening and COMPASS MS intervention
Time Frame: Baseline only
- The clinical team will collect data on the route of referral to mental health team (completed routine screening, was referred/self-referred).
Baseline only
Reach of screening and COMPASS MS intervention
Time Frame: Baseline only
- If referred, the clinical team will collect data on the who the referring clinician is and their professional background.
Baseline only
Reach of screening and COMPASS MS intervention
Time Frame: Baseline only
- The clinical team will collect data on patient attendance at triage appointment and care pathway recommended (including referral to COMPASS-MS)
Baseline only
Reach of screening and COMPASS MS intervention
Time Frame: Baseline only
- the clinical team will collect data on the outcome of screening (e.g eligible for COMPASS-MS intervention or not)
Baseline only
Efficacy: psychological outcomes
Time Frame: baseline 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.
baseline and 12 week follow up
Efficacy: psychological outcomes
Time Frame: baseline and 12 week follow up
- The investigators will measure Expression of emotion will be measured using the Beliefs about Emotions Scale.
baseline and 12 week follow up
Efficacy: Psycho-social outcomes
Time Frame: 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).
baseline and 12 week follow up
Implementation of COMPASS
Time Frame: post 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
post treatment (12 week follow up)
Implementation of COMPASS
Time Frame: post treatment (12 week follow up)
The investigators will investigate the implementation of COMPASS by collecting descriptive data on patient adherence to COMPASS online sessions.
post treatment (12 week follow up)
Implementation of COMPASS
Time Frame: post treatment (12 week follow up)
The investigators will investigate the implementation of COMPASS by collecting descriptive data on the number and duration of therapist calls attended.
post treatment (12 week follow up)
Implementation of COMPASS
Time Frame: post treatment (12 week follow up)
The investigators will investigate the implementation of COMPASS by collecting descriptive data on the dropout rate of COMPASS.
post treatment (12 week follow up)
Adoption
Time Frame: 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).
12 weeks follow up (post treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 335756

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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