Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)

NCT05956912 | Unknown

• 2 other identifiers: IRAS ID: 31367729567
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. Depression and anxiety are common among CR patients, and current psychological treatments for cardiac patients have minor effects. However, the NIHR-funded PATHWAY trial found that group Metacognitive Therapy (MCT) was associated with improvements in anxiety and depression when added to CR and was more effective than usual CR alone. Group MCT was also associated with preventing anxiety and depression. The next steps will establish beacon sites for delivering MCT and pilot-test additions to the national audit of cardiac rehabilitation (NACR) data capture mechanism to include an MCT data field. Such steps will support a quantitative and qualitative evaluation of implementation. Methods: The investigators aim to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending MCT, the impact of adding MCT to CR on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. The investigators will deliver training in group MCT to CR staff from CR services across England. The investigators will conduct semi-structured qualitative interviews with CR staff trained in group MCT to assess views on the training programme, including successes and barriers to implementation of training and delivery. The investigators will interview 8-10 CR stakeholders to identify any barriers to implementation and how these might be resolved. Discussion: The study will support development of an NHS roll-out strategy and systematic data collection that can be used to evaluate wide-scale implementation. The study can benefit service users by improving patients' mental health outcomes and CR practitioners' clinical skills. Results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.

Conditions

Anxiety; Depression; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adoption of group MCT

  Successful adoption of group MCT at each site is set a-priori. A traffic-light criteria will be used to determine successful adoption. 1. Green - achieved all of the following: a) Delivered two 6-session group MCT courses (b) at least three patients per group, and (c) a combined total of at least 60% attending four or more sessions. 2. Amber - achieved one of the three criteria given above. 3. Red - achieved none of the criteria. A Green rating indicates that a site has fully met the criteria for successful adoption. Red indicates a failure to meet the requirements. Amber is partial adoption, where amendments to procedures and protocols might lead to successful adoption. At Amber sites, specific qualitative work will be undertaken to understand the reasons for not meeting criteria more fully and to help develop strategies to ameliorate this. An overall assessment will be made considering the traffic-light ratings of all six beacon sites.

  Within the 6 months that MCT is being delivered in CR services

Secondary Outcomes (6)

• Dartmouth Coop

  Initial Cardiac Rehabilitation Assessment (Baseline) & Within 6 months of attending cardiac rehabilitation (Discharge)

• Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)

  1 month prior to training in MCT

• Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)

  Within 1 month of delivering the pilot group of MCT

• Semi-structured interviews will explore the views and opinions of group-MCT in CR (CR staff trained in group-MCT)

  Upon completion of delivering group-MCT, approximately 5 months after starting the delivery of MCT in CR

• Semi-structured interviews will explore the views and opinions of group-MCT in CR (CCG and other management stakeholders)

  Through implementation of MCT in CR services, approximately 7 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac rehabilitation staff trained in delivering Group-MCT, wider cardiac rehabilitation staff and managers, and healthcare professionals from local clinical commissioning groups. All CR patients attending cardiac rehabilitation.

You may qualify if:

• Be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-MCT
• Be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level
• Minimum of 18 years old
• Competent level of English Language skills (able to read, understand and complete interviews in English).

You may not qualify if:

• Below 18 years of age
• Not a healthcare professional or professional working at the commissioner level
• Does not have a competent level of English language skills
• All patients attending CR who meet the NICE recommendations for acute coronary syndrome (NG185) and heart failure (NG106) will be offered group MCT as part of routine CR.

Sponsors & Collaborators

• University of Manchester: lead
• Greater Manchester Mental Health NHS Foundation Trust: collaborator
• University of York: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• Wells A, Reeves D, Belcher A, Wilson P, Doherty P, Capobianco L. Protocol for an implementation study of group metacognitive therapy for anxiety and depression in NHS cardiac rehabilitation services in England (PATHWAY-Beacons). Front Health Serv. 2024 Oct 17;4:1296596. doi: 10.3389/frhs.2024.1296596. eCollection 2024.

  PMID: 39483442 DERIVED

Related Links

• Research Project Website Page

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Adrian Wells, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Wells, PhD

CONTACT

01612765399; adrian.wells@manchester.ac.uk

Lora Capobianco, PhD

CONTACT

01610046664; lora.capobianco@gmmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical and Experimental Psychopathology

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: July 24, 2023
• Study Start: September 6, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

GB (1)