AzTrials
AzTrials

Multiple SclerosisNCT06222359

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

An observational study of Multiple Sclerosis and Depression, run by King's College London.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Depression, Anxiety
What is being tested?
COMPASS
Type of treatment
Medical device
How many people
102 participants
Where
No sites listed yet
Study dates
Feb 2024to Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

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:
  6. 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).

About this study

Official title: 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.

Read the 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).

Being tested
COMPASS
Medical subject headings
Multiple Sclerosis, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMPASSDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological Distress (primary outcome for a future full scale trial).

    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.

    Measured: baseline and 12 week follow up

Secondary outcomes (12)

  1. Reach of screening and COMPASS MS intervention

    • The clinical team will collect data on the route of referral to mental health team (completed routine screening, was referred/self-referred).

    Measured: Baseline only

  2. Reach of screening and COMPASS MS intervention

    • If referred, the clinical team will collect data on the who the referring clinician is and their professional background.

    Measured: Baseline only

  3. Reach of screening and COMPASS MS intervention

    • The clinical team will collect data on patient attendance at triage appointment and care pathway recommended (including referral to COMPASS-MS)

    Measured: Baseline only

  4. Reach of screening and COMPASS MS intervention

    • the clinical team will collect data on the outcome of screening (e.g eligible for COMPASS-MS intervention or not)

    Measured: Baseline only

  5. Efficacy: psychological outcomes

    • 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.

    Measured: baseline and 12 week follow up

  6. Efficacy: psychological outcomes

    • The investigators will measure Expression of emotion will be measured using the Beliefs about Emotions Scale.

    Measured: baseline and 12 week follow up

  7. Efficacy: Psycho-social outcomes

    • The investigators will measure Healthcare usage using the 4 service use items from the Client Service Receipt Inventory (CSRI).

    Measured: baseline and 12 week follow up

  8. Implementation of COMPASS

    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

    Measured: post treatment (12 week follow up)

  9. Implementation of COMPASS

    The investigators will investigate the implementation of COMPASS by collecting descriptive data on patient adherence to COMPASS online sessions.

    Measured: post treatment (12 week follow up)

  10. Implementation of COMPASS

    The investigators will investigate the implementation of COMPASS by collecting descriptive data on the number and duration of therapist calls attended.

    Measured: post treatment (12 week follow up)

  11. Implementation of COMPASS

    The investigators will investigate the implementation of COMPASS by collecting descriptive data on the dropout rate of COMPASS.

    Measured: post treatment (12 week follow up)

  12. Adoption

    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).

    Measured: 12 weeks follow up (post treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study startFeb 2024 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06222359
Sponsor's protocol ID
335756
Status last verified
Oct 2023
First submitted
3 Nov 2023
Last updated
24 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.

    PubMed 27187854

  • Carleton RN, Norton MA, Asmundson GJ. Fearing the unknown: a short version of the Intolerance of Uncertainty Scale. J Anxiety Disord. 2007;21(1):105-17. doi: 10.1016/j.janxdis.2006.03.014. Epub 2006 May 2.

    PubMed 16647833

  • Rimes KA, Chalder T. The Beliefs about Emotions Scale: validity, reliability and sensitivity to change. J Psychosom Res. 2010 Mar;68(3):285-92. doi: 10.1016/j.jpsychores.2009.09.014. Epub 2009 Dec 9.

    PubMed 20159215

  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PubMed 10109801

  • Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

    PubMed 11983645

  • Ryan EG, Vitoratou S, Goldsmith KA, Chalder T. Psychometric Properties and Factor Structure of a Long and Shortened Version of the Cognitive and Behavioural Responses Questionnaire. Psychosom Med. 2018 Feb/Mar;80(2):230-237. doi: 10.1097/PSY.0000000000000536.

    PubMed 29023262

  • Stuifbergen A, Becker H, Blozis S, Beal C. Conceptualization and development of the Acceptance of Chronic Health Conditions Scale. Issues Ment Health Nurs. 2008;29(2):101-14. doi: 10.1080/01612840701792548.

    PubMed 18293219

  • Thornicroft, G. (2001). An adapted version of the Client Service Receipt Inventory. Costing psychiatric interventions. London: Measuring Mental Health Needs.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Depression, run by King's College London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Distress (primary outcome for a future full scale trial). (time frame: baseline and 12 week follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06222359, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in