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

NCT06222359 | Unknown

• 1 other identifier: 335756
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis; Depression; Anxiety

Outcome Measures

Primary Outcomes (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.

  baseline and 12 week follow up

Secondary Outcomes (12)

• Reach of screening and COMPASS MS intervention

  Baseline only

• Reach of screening and COMPASS MS intervention

  Baseline only

• Reach of screening and COMPASS MS intervention

  Baseline only

• Reach of screening and COMPASS MS intervention

  Baseline only

• Efficacy: psychological outcomes

  baseline and 12 week follow up

Interventions

COMPASS DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:
• Work in a Neurology Service in England including both inpatient services and MS therapy centres.
• Have direct patient experience with working with PwMS (e.g. Neurologist, Doctor, Nurse, Reception)
• Work alongside a Neurology services in England and are involved in the care of PwMS (e.g. pharmacy/physiotherapy/commissioning bodies).

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator

Related Publications (8)

• 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.

  PMID: 27187854 BACKGROUND

• 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.

  PMID: 16647833 BACKGROUND

• 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.

  PMID: 20159215 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

• 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.

  PMID: 11983645 BACKGROUND

• 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.

  PMID: 29023262 BACKGROUND

• 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.

  PMID: 18293219 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2023-10