Search / Trial NCT06222359

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

Launched by KING'S COLLEGE LONDON · Jan 15, 2024

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Trial Information

Current as of October 07, 2024

Not yet recruiting

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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...

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Eligibility criteria

  • 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).

About King's College London

King's College London is a prominent research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the college leverages its extensive expertise in medicine, neuroscience, and public health to conduct rigorous studies aimed at improving patient outcomes. As a sponsor of clinical trials, King's College London prioritizes ethical standards, participant safety, and scientific integrity, fostering an environment that encourages groundbreaking research and the translation of findings into clinical practice. Through its state-of-the-art facilities and a diverse network of researchers, the institution strives to address critical health challenges and contribute to the global body of medical knowledge.

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