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

U

University of Manchester

Status

Enrolling

Conditions

Cardiac Rehabilitation
Depression
Anxiety

Study type

Observational

Funder types

Other

Identifiers

NCT05956912
IRAS ID: 313677
29567 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Qualitative Inclusion Criteria:

All CR staff must meet the following inclusion criteria to be eligible:

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

Exclusion Criteria:

  1. Below 18 years of age
  2. Not a healthcare professional or professional working at the commissioner level
  3. Does not have a competent level of English language skills

Audit inclusion criteria:

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.

Trial contacts and locations

1

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Central trial contact

Lora Capobianco, PhD; Adrian Wells, PhD

Data sourced from clinicaltrials.gov

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