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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMPASS | Device | Digital CBT to treat psychological distress in Multiple Sclerosis (MS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reach of screening and COMPASS MS intervention |
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Patients will be eligible for inclusion for the COMPASS-MS intervention if they are:
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:
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:
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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
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27187854 | Background | 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. | |
| 16647833 | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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- 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 | - 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 | - 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 | - 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 | - 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 | - 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 | 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 | 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 | 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 | 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 | 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) |
| 20159215 | 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. |
| 10109801 | 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. |
| 11983645 | 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. |
| 29023262 | 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. |
| 18293219 | 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. |
| Background | Thornicroft, G. (2001). An adapted version of the Client Service Receipt Inventory. Costing psychiatric interventions. London: Measuring Mental Health Needs. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |