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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06222359
• Other study ID #: 335756
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 distress in routine care.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• COMPASS
Digital CBT to treat psychological distress in Multiple Sclerosis (MS)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 12 week follow up
Secondary	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).	Baseline only
Secondary	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.	Baseline only
Secondary	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)	Baseline only
Secondary	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)	Baseline only
Secondary	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.	baseline and 12 week follow up
Secondary	Efficacy: psychological outcomes	- The investigators will measure Expression of emotion will be measured using the Beliefs about Emotions Scale.	baseline and 12 week follow up
Secondary	Efficacy: Psycho-social outcomes	- 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
Secondary	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	post treatment (12 week follow up)
Secondary	Implementation of COMPASS	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)
Secondary	Implementation of COMPASS	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)
Secondary	Implementation of COMPASS	The investigators will investigate the implementation of COMPASS by collecting descriptive data on the dropout rate of COMPASS.	post treatment (12 week follow up)
Secondary	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).	12 weeks follow up (post treatment)